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NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Trial info - trialinfo@nspharma.com

NCT05996003
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Inclusion Criteria:
* Male ≥ 4 years and \<15 years of age * Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame * Able to walk independently without assistive devices * Ability to complete the TTSTAND without assistance in \<20 seconds * Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study. * Other inclusion criteria may apply.
Exclusion Criteria:
* Has a body weight of \<20 kg at the time of informed consent (applies to participants screening for Part 1 only) * Evidence of symptomatic cardiomyopathy * Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug * Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer * Surgery within the 3 months prior to the first dose of study drug or planned during the study duration * Previously treated in an interventional study of NS-089/NCNP-02 * Having taken any gene therapy. * Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP or is expected to receive exon skipping oligonucleotide prior to completion of study. * Other exclusion criteria may apply.
DRUG: NS-089/NCNP-02
Duchenne Muscular Dystrophy, Exon 44, DMD
Exon 44 Skipping, DMD
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Study Locations

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Location Contacts
Alberta Children's Hospital Calgary, Alberta Julie Dao - (julie.dao@ucalgary.ca)
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Raven Hill - (rhill@luriechildrens.org) Alka Maheshwari - (amaheshwari@luriechildrens.org)
Children's Hospital Colorado Aurora, Colorado Hannah Kleiner - (hannah.kleiner@childrenscolorado.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Angela Edmondson - (Angela.Edmondson@cchmc.org)
London Health Sciences Centre London, Teresa Longfield - (teresa.longfield@lhsc.on.ca)
NHO Osaka Toneyama Medical Center Toyonaka, Osaka Clinical Trial Office - (410-chiken@mail.hosp.go.jp)
National Center of Neurology and Psychiatry Kodaira, Tokyo
National Hospital Organization Nagara Medical Center Nagara, Gifu-shi, Gifu Clinical Trial Management Office - (yonekura.kei.wu@mail.hosp.go.jp)
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do JaeYoon Kim - (lusterwuzz@naver.com)
Rare Disease Research Atlanta, Georgia Julia Zhu - (julia.zhu@rarediseaseresearch.com)
Rare Disease Research, LLC - FL Kissimmee, Florida Marcial Almaraz - (marcial.almaraz@rarediseaseresearch.com)
Seoul National University Hospital Seoul, Hyeon Ju Kwon - (hjkwon@snuh.org; 49041@snuh.org)
Shiga General Hospital Moriyama-shi, Shiga Children's Building - (kenji.s.address@gmail.com)
UT Southwestern/Children's Health Dallas, Texas Deniece Winston - (Deniece.Winston@UTSouthwestern.edu)
University of Kansas Medical Center (KUMC) Kansas City, Kansas Rebecca Clay - (rclay@kumc.edu)
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania Vibha Chauhan - (vibha.chauhan@chp.edu)
Virginia Commonwealth University Health System Richmond, Virginia Andrea Jewell - (andrea.jewell@vcuhealth.org)

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer (SUNRAY-02)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

NCT06890598
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Inclusion Criteria:
* Histological or cytological confirmation of NSCLC. * Part A
• Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
• Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection. * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Must have an ECOG performance status of 0 or 1. * Able to swallow oral medication. * Must have adequate laboratory parameters. * Contraceptive use should be consistent with local regulations for those participating in clinical studies. * Women of childbearing potential must * Have a negative pregnancy test. * Not be breastfeeding during treatment
Exclusion Criteria:
* Have known changes in the EGFR or ALK genes. * Have another type of cancer that is progressing or required active treatment within the past 3 years before screening. * Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed. * Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
DRUG: Olomorasib, DRUG: Pembrolizumab, DRUG: Durvalumab, DRUG: Placebo
Carcinoma, Non-Small-Cell Lung
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Study Locations

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AHN Allegheny General Hospital Pittsburgh, Pennsylvania
ASST Grande Ospedale Metropolitano Niguarda Milan,
AZ Delta vzw Roeselare,
Adana City Hospital Adana,
Agios Loukas Clinic Thessaloniki,
Agios Savvas Regional Cancer Hospital Athens,
Aichi Cancer Center Hospital Aichi, Nagoya,
Amphia Ziekenhuis, locatie Breda Molengracht Breda,
Amsterdam UMC, locatie VUmc Amsterdam,
Antalya Egitim ve Arastırma Hastanesi Antalya,
Antwerp University Hospital Edegem, Antwerp
Anyang Cancer Hospital Anyang,
Asan Medical Center Seoul,
Asklepios Fachkliniken München-Gauting Gauting,
Asklepios Klinik Harburg Hamburg,
Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille,
Austin Health Heidelberg, Victoria
Azienda Ospedaliera Dei Colli Naples,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona,
Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano,
BASS Cancer Center Walnut Creek, California
Baptist Health Hamburg Lexington, Kentucky
Baptist Health Lexington Lexington, Kentucky
Baskent University Dr. Turgut Noyan Research and Training Center Adana,
Beijing Cancer Hospital Beijing,
Boca Raton Regional Hospital Boca Raton, Florida
Bradfordhill Santiago,
Budapesti Uzsoki Utcai Korhaz Budapest,
Buddhist Dalin Tzu Chi General Hospital Chiayi City,
CHI Saint Joseph Cancer Center - East Lexington, Kentucky
CHIREC - site delta Auderghem,
CHU Bordeaux Haut-Leveque Pessac,
CHU Grenoble Alpes La Tronche,
CHU de Toulouse - Hopital Larrey Toulouse,
CHUS - Hospital Clinico Universitario Santiago de Compostela,
CTO - Centro de Tratamento Oncológico Belém,
Cancer Care Northwest - Vercler Spokane Valley, Washington
Cancer Hospital Chinese Academy of Medical Science Beijing,
Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center Shenzhen,
Cancer Hospital of Shantou University Medical College Shantou,
Captain James A. Lovell Federal Health Care Center North Chicago, Illinois
Centre Antoine-Lacassagne Nice,
Centre Hospitalier Universitaire de Poitiers Poitiers,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes,
Centre Leon Berard Lyon,
Centro Hospitalar E Universitário De Coimbra Coimbra,
Centro Paulista de Oncologia Clínica São Paulo,
Centro de Oncología de Precisión Santiago,
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará Fortaleza,
Centro de Pesquisa Sao Lucas Campinas,
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA Rio de Janeiro,
Chang Gung Medical Foundation-LinKou Branch Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City,
Changhua Christian Hospital Changhua County,
Chi Mei Hospital - Liouying Branch Tainan City,
Chi Mei Medical Center Tainan, Tainan
China-Japan Friendship Hospital Beijing,
Chonnam National University Hwasun Hospital Hwasun-gun,
Chung Shan Medical University Hospital Taichung,
Chungbuk National University Hospital Chungju,
Clearview Cancer Institute Huntsville, Alabama
Cleveland Clinic Cleveland, Ohio
Columbia University Irving Medical Center New York, New York
Complejo Hospitalario de Navarra Pamplona,
Comprehensive Hematology Oncology St. Petersburg, Florida
DRK Kliniken Berlin Mitte Berlin,
Deenanath Mangeshkar Hospital & Research Centre Pune,
Drammen Sykehus, Vestre Viken HF Drammen,
E-DA Hospital Kaohsiung City,
ETZ Elisabeth Tilburg,
Errikos Dunant Hospital Center Athens,
European Interbalkan Medical Center Thessaloniki,
Evangelische Lungenklinik Berlin Berlin,
Evangelisches Krankenhaus Herne - Eickel Herne,
FALP Santiago,
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Banská Bystrica,
Fakultni nemocnice Bulovka Prague,
Far Eastern Memorial Hospital New Taipei City,
Farkasgyepui Tudogyogyintezet Farkasgyepű,
Florida Cancer Specialists - South Fort Myers, Florida
Florida Cancer Specialists East West Palm Beach, Florida
Florida Cancer Specialists North St. Petersburg, Florida
Franciscan Health Indianapolis, Indiana
Franziskus-Hospital Harderberg Georgsmarienhütte,
Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo
Galaxy Superspeciality Hospital Aurangabad,
Gangnam Severance Hospital, Yonsei University Health System Seoul,
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep,
Goulburn Valley Health Shepparton,
Groupe hospitalier Paris saint Joseph Paris,
Guangdong Provincial People's Hospital Guangzhou,
Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi
Gustave Roussy Villejuif,
H.R.U Málaga - Hospital General Málaga,
HELIOS Klinikum Erfurt Erfurt,
HFR Fribourg - Hôpital cantonal Fribourg,
Harbin Medical University Cancer Hospital Harbin, Heilongjiang
Hartford Hospital (HH) Hartford, Connecticut
Haukeland Universitetssjukehus Bergen,
Heartlands Hospital Birmingham,
Hemato Oncology Clinic Ahmedabad,
Highlands Oncology Group Springdale, Arkansas
Himeji Medical Center Himeji,
Hokkaido University Hospital Hokkaido, Sapporo,
Hospices Civils de Lyon - Hopital Louis Pradel Bron,
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico Universitario Lozano Blesa Zaragoza,
Hospital Clinico de Valencia Valencia,
Hospital Cuf porto Porto,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Infanta Cristina Badajoz,
Hospital Insular de Gran Canaria Las Palmas de Gran Canaria,
Hospital Jerez de la Frontera Jerez de la Frontera,
Hospital Santa Catarina - Paulista São Paulo,
Hospital Sao Lucas da PUCRS Porto Alegre,
Hospital Sirio Libanes São Paulo,
Hospital Tacchini Bento Gonçalves,
Hospital Universitari Son Espases Palma de Mallorca,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hospital da Luz Lisboa Lisbon,
Hospital de Cancer de Londrina Londrina,
Houston Methodist Hospital Houston, Texas
Hualien Tzu Chi Medical Center Hualien City,
Hubei Cancer Hospital Wuhan,
Huddersfield Royal Infirmary Huddersfield,
Hunan Cancer Hospital Changsha, Hunan
Hunan Cancer Hospital Changsha, Hunan
Hôpital Européen Georges Pompidou Paris,
Hôpital Robert Schuman Vantoux,
ICON Cancer Centre - Kurralta Park Kurralta Park,
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Icon Cancer Centre Wesley Auchenflower,
Institut Curie Paris,
Institut Jean Godinot Reims,
Institut de Cancerologie de l'Ouest Saint-Herblain,
Instituto Catalan de Oncologia - Hospital Duran i Reynals Hospitalet,
Instituto D'Or Pesquisa e Ensino Rio de Janeiro,
Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo,
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto,
Instituto Tumori Giovanni Paolo II Bari,
Institutul Oncologic Cluj-Napoca,
Isala, locatie Zwolle Zwolle,
Istituto Nazionale Tumori Regina Elena Rome,
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola,
Izmir Atatürk Training and Research Hospital Izmir,
Jefferson Health - Cherry Hill Cherry Hill, New Jersey
Jefferson Hospital Northeast Philadelphia, Pennsylvania
Jilin Cancer Hospital Changchun,
Jinan Central Hospital Jinan,
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey
Johns Hopkins Bayview Medical Center Baltimore, Maryland
Juntendo University Hospital Bunkyo-ku, Tokyo
K2 Oncology Providencia,
Kaiser Permanente Interstate Medical Office Central Portland, Oregon
Kaiser Permanente San Diego Mission Road San Diego, California
Kanagawa Cancer Center Yokohama, Kanagawa
Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama,
Kanazawa University Hospital Kanazawa,
Kansai Medical University Hospital Hirakata, Osaka
Kantonsspital Baden Baden,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karmanos Cancer Institute Detroit, Michigan
Keimyung University Dongsan Hospital Daegu,
Klinik Floridsdorf Vienna,
Klinikum Chemnitz Chemnitz,
Klinikum Koln-Merheim Cologne,
Klinikum Nürnberg Nord Nuremberg,
Konkuk University Medical Center Seoul,
Korea University Guro Hospital Seoul,
Kouros Moccia Oncologia Locarno,
Krankenhaus Martha-Maria Halle-Dölau Halle,
Kyungpook National University Chilgok Hospital Daegu,
Kyushu University Hospital Fukuoka, Fukuoka,
Latrobe Regional Health Traralgon,
Lexington Medical Center West Columbia, South Carolina
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
Liuzhou People's Hospital Liuzhou,
Lotus-Med Bucharest,
LungenClinic Grosshansdorf Großhansdorf,
MV-Zentrum für Onkologie und Hämatologie Cologne,
Malabar Cancer Centre - Thalassery Thalassery,
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Pendik,
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Medipoint Hospitals Pvt. Ltd. Pune,
Medizinische Universität Graz Graz,
Meir Medical Center Kfar Saba,
Memorial Sloan Kettering Cancer Center New York, New York
Miami Cancer Institute at Baptist Health, Inc. Miami, Florida
Missouri Baptist Medical Center St Louis, Missouri
Miyagi Cancer Center Natori,
Moffitt Cancer Center Tampa, Florida
NHO Kinki Chuo Chest Medical Center Sakai,
National Cancer Center Gyeonggi-do,
National Cancer Center Hospital East Chiba, Kashiwa,
National Cheng Kung University Hospital Tainan,
National Taiwan University Cancer Center (NTUCC) Taipei,
National Taiwan University Hospital Taipei,
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region Douliu,
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) Amsterdam,
Nemocnice AGEL Ostrava - Vitkovice a.s. Ostrava,
New England Cancer Specialists Westbrook, Maine
New Taipei Municipal TuCheng Hospital New Taipei City,
Niigata Cancer Center Hospital Niigata,
Northport VA Medical Center Northport, New York
Northwest Cancer Specialists PC Vancouver, Washington
Ochsner Clinic Foundation Jefferson, Louisiana
Ochsner Health Ochsner Cancer Center - Baton Rouge Baton Rouge, Louisiana
Oncocentro de Minas Gerais Belo Horizonte,
One Day Med Szczecin,
Onkologiezentrum Donauwörth Donauwörth,
Ordensklinikum Linz GmbH Elisabethinen Linz,
Oregon Health and Science University Portland, Oregon
Orszagos Onkologiai Intezet Budapest,
Oslo universitetssykehus, Radiumhospitalet Oslo,
Ospedale San Gerardo-ASST Monza Monza,
Ospedale San Martino Genova,
Ovidius Clinical Hospital OCH Ovidiu,
Pacific Medical College & Hospital Udaipur,
Parc de Salut Mar - Hospital del Mar Barcelona,
Parkview Research Center at Parkview Regional Medical Center Fort Wayne, Indiana
Peking University People's Hospital Beijing,
Policlinico "G. Rodolico" Catania,
Profound Research LLC Oceanside, California
Providence Portland Medical Center Portland, Oregon
Providence St. Vincent Medical Center Portland, Oregon
Pusan National University Hospital Seogu, Busan Gwang'yeogsi
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do
Rajiv Gandhi Government General Hospital Chennai,
Rambam Health Care Campus Haifa,
Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram,
Reliant Medical Group Worcester, Massachusetts
Robert Bosch Krankenhaus GmbH Stuttgart,
Royal Marsden Hospital (Chelsea) London,
Royal Marsden Hospital (Sutton) Sutton,
SC Memorial Healthcare International SRL Bucharest,
SCRI Oncology Partners Nashville, Tennessee
Sahlgrenska Universitetssjukhuset Gasteborg,
Saitama Medical University International Medical Center Saitama,
Sakarya University School of Medicine Adapazarı,
Samsun Medical Park Hastanesi Samsun,
Samsung Medical Center Seoul,
Sarah Cannon Research Institute London, England
Savera Cancer & Multi Speciality Hospital Patna,
Seoul National University Bundang Hospital Seongnam-si,
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
Shandong Cancer Hospital Jinan, Shandong
Shanghai Chest Hospital Shanghai,
Sheba Medical Center Ramat Gan,
Shenzhen People's Hospital Shenzhen,
Shizuoka Cancer Center Shizuoka,
Sibley Memorial Hospital Washington D.C., District of Columbia
Sichuan Cancer Hospital Chengdu,
Sidney Kimmel Cancer Center - Washington Township Sewell, New Jersey
Sir Charles Gairdner Hospital Nedlands, Western Australia
Sir H. N. Reliance Foundation Hospital and Research Centre Mumbai, Maharashtra
Sorlandet Sykehus Arendal Arendal,
Springfield Clinic Main Campus Springfield, Illinois
St. Antonius Ziekenhuis, locatie Utrecht Utrecht,
St. Elisabeth-Krankenhaus Leipzig Leipzig,
Stanford Cancer Center Palo Alto, California
Sunshine Coast University Hospital Birtinya, Queensland
Swedish Cancer Institute - Edmonds Edmonds, Washington
Swedish Medical Center Englewood, Colorado
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej Kielce,
Sykehuset Innlandet HF Gjøvik Gjøvik,
Taichung Veterans General Hospital Taichung, China
Taipei Veterans General Hospital Taipei, Beitou District / R.o.c.
Taizhou Hospital of Zhejiang Province Taizhou,
Tamworth Hospital North Tamworth,
Tata Memorial Centre - Homi Bhabha Cancer Hospital Varanasi,
Tennessee Oncology Nashville, Tennessee
Tennessee Oncology Chattanooga Chattanooga, Tennessee
Thangam Cancer Center - Namakkal Namakkal,
The Cancer Institute Hospital of JFCR Tokyo,
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul,
The Catholic University Of Korea St. Vincent's Hospital Suwon,
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Eunpyeong-gu
The Catholic University of Korea, Incheon St. Mary's Hospital Incheon,
The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul,
The Center for Cancer and Blood Disorders Fort Worth, Texas
The Christie NHS Foundation Trust Manchester,
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The First Affiliated Hospital of Henan University of Science &Technology Luoyang,
The First Affiliated Hospital of Soochow University Suzhou, Jiangsu
The First Affiliated Hospital of Xi'An Jiaotong University Xi’an, Shanxi
The First People's Hospital of Foshan Foshan,
The Second Affiliated Hospital Chongqing Medical University Chongqing,
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang
The Second People's Hospital of Neijiang Neijiang,
The Third People's Hospital of Chengdu (CDTPH) Chengdu,
The University of Arizona Cancer Center - North Campus Tucson, Arizona
The University of Vermont Medical Center Inc. Burlington, Vermont
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office Philadelphia, Pennsylvania
Thoracic General Hospital of Athens "I Sotiria" Athens,
Thoraxklinik-Heidelberg gGmbH Heidelberg,
Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin Municipality
Tokyo Metropolitan Komagome Hospital Bunkyō City,
Tongji Hospital Tongji Medical,Science & Technology Wuhan, Hubei
Torbay Hospital Torquay,
Tottori University Hospital Yonago, Tottori
Trakya University Edirne,
UCLA Hematology/Oncology - Santa Monica Los Angeles, California
USO - Texas Oncology - San Antonio San Antonio, Texas
USO - Texas Oncology Gulf Coast Sugar Land, Texas
USO - US Oncology Research Network The Woodlands, Texas
UZ Leuven Leuven,
Universitaetsklinikum Tuebingen Tübingen,
University General Hospital of Heraklion Heraklion, Crete,
University General Hospital of Larissa Larissa,
University Hospital and UW Health Clinics Madison, Wisconsin
University Hospital of Patras Pátrai,
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University Hospitals Sussex NHS Foundation Trust East Sussex,
University of Alabama at Birmingham Birmingham, Alabama
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange, California
University of Chicago Medical Center Chicago, Illinois
University of Florida - Jacksonville Jacksonville, Florida
University of Illinois at Chicago Chicago, Illinois
University of Maryland Baltimore, Maryland
University of Tennessee Medical Center Knoxville, Tennessee
University of Texas MD Anderson Cancer Center Houston, Texas
University of Virginia Health System Charlottesville, Virginia
Univerzitná nemocnica Bratislava - Nemocnica Ružinov Bratislava,
VCU Health Adult Outpatient Pavillion Richmond, Virginia
Vivantes Klinikum im Friedrichshain - Landsberger Allee Berlin,
Vychodoslovensky Onkologicky ustav a.s. Košice,
Wakayama Medical University Hospital Wakayama,
West China Hospital, Sichuan University Chengdu, Sichuan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan,
Xiangya Hospital Central South University Changsha,
Xiangya Hospital Central South University Changsha,
Yeungnam Univeristy Medical Center Nam-gu,
Zhejiang Cancer Hospital Zhejiang,
Zhejiang Cancer Hospital Zhejiang,
Zhejiang Provincial People's Hospital Hangzhou,
Zhongshan Peoples Hospital Zhongshan,
ZhuZhou Central Hospital Zhuzhou,
Ziekenhuis St. Jansdal Harderwijk,
İ.A.Ü VM Medical Park Florya Hastanesi Istanbul,

The CONFORM Pivotal Trial

Aly Dechert, MS - adechert@conformalmedical.com

NCT05147792
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Inclusion Criteria:

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
• Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
• Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
• Able to comply with the protocol-specified medication regimen and follow-up evaluations
• The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).
Exclusion Criteria:

• Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Documented active systemic infection
• Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment
• Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
• Recent (within 30 days of index procedure) stroke or transient ischemic attack
• Recent (within 30 days of index procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
• Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
• Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Unable to undergo general anesthesia
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
• A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
• Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)
• Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE prior to implant
• Left ventricular ejection fraction (LVEF) \<30%
• Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
• Atrial septal defect that warrants closure
• High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20)
• Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Evidence of cardiac tumor
DEVICE: CLAAS, DEVICE: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Atrial Fibrillation, Stroke
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Study Locations

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Location Contacts
AKFA Medline Olmazor, Tashkent
Abrazo Arizona Heart Hospital Phoenix, Arizona
AdventHealth Orlando Orlando, Florida Chantie Garvey - (chantie.garvey@adventhealth.com)
AdventHealth Tampa Tampa, Florida Daniel Robledo - (daniel.robledo@adventhealth.com)
Albany Medical Center / Capital Cardiology Associates Albany, New York Mara Zink - (mzink@capitalcardiology.com)
Ascension St. Vincent - Carmel, IN Indianapolis, Indiana
Ascension St. Vincent's Jacksonville Jacksonville, Florida
Baptist Hospital of Miami Miami, Florida Maria Ardid - (mariaar@baptisthealth.net)
Baystate Medical Center Springfield, Massachusetts Christine Callahan - (Christine.Callahan@baystatehealth.org)
CHI Health / CommonSpirit Research Institute Omaha, Nebraska Maddie Esch - (maddie.esch@commonspirit.org)
CHRISTUS Health Tyler, Texas Jamie-Crystal Wylie - (jamiecrystal.wylie@christushealth.org)
Carilion Clinic Roanoke, Virginia Brittny O'Toole - (bmotoole@carilionclinic.org)
Catholic Medical Center Manchester, New Hampshire
Centracare Heart and Vascular Center Saint Cloud, Minnesota Audrey Hillebrand-Raap - (Audrey.Hillenbrand-Raap@centracare.com)
Chapidze Heart Disease Center Tbilisi, Teona Gamezardashvili - (t.gamezardashvili@clinicalaccelerator.com) Beka Khakhutashvili - (b.khakhutashvili@clinicalaccelerator.com)
Chippenham Hospital Richmond, Virginia Ariana Dickens - (Ariana.Dickens@hcahealthcare.com)
Community Memorial Hospital Ventura Ventura, California Melissa Grant - (melissa@siteresearchmgmt.com)
Cooper University - Heart House Haddon Heights, New Jersey Kaitlyn Downey - (KDowney@hearthousenj.com)
Corewell Health Grand Rapids, Michigan
Emory University Atlanta, Georgia Teressa Burns - (teressa.burns@emory.edu)
Erlanger Health System Chattanooga, Tennessee Kumari Kasa - (Parvathikumari.Kasa@erlanger.org)
Grandview Medical Center Birmingham, Alabama Kristy Raco - (kristy.raco@grandviewhealth.com)
Hackensack University Medical Center Hackensack, New Jersey Tarah Martelly - (tarah.martelly@hmhn.org)
Henry Ford Providence Southfield Hospital Southfield, Michigan
Henry Ford St. John Hospital Detroit, Michigan Renee Bess - (rbess1@hfhs.org)
HonorHealth Scottsdale, Arizona Kiersten Rundio - (krundio@honorhealth.com)
Houston Methodist Houston, Texas Chinwe Ngumezi - (ccngumezi@houstonmethodist.org)
Huntington Hospital Huntington, New York Samia Solh - (Samia.Solh@huntingtonhealth.org)
Hôpital Privé Jacques Cartier Massy, Séverine Roger - (s.roger@icps.com.fr)
Israeli-Georgian Medical Research Clinic Helsicore Tbilisi, Natalia Cornea - (n.cornea@clinicalaccelerator.com) Teona Gamazerdashvili - (t.gamezardashvili@clinicalaccelerator.com)
Kansas City Cardiac Arrhythmia Research, LLC Overland Park, Missouri Rachael Koeppe - (rachael.koeppe@hcahealthcare.com)
Lahey Hospital & Medical Centeer Burlington, Massachusetts Jean Byrne - (jean.byrne@lahey.org)
Lankenau Heart Institute Wynnewood, Pennsylvania Rachael Cohen - (cohenrac@mlhs.org)
Largo Medical Center Upper Marlboro, Maryland Holly Lynn Grospitch - (HollyLynn.Grospitch@hcahealthcare.com)
Legacy Emanuel Hospital and Health Portland, Oregon Karla Kummer - (kkummer@lhs.org)
Lifespan Health System Providence, Rhode Island
M Health Fairview St. John's Hospital Maplewood, Minnesota Beth Jorgenson - (beth.jorgenson@fairview.org)
MedStar Union Memorial Hospital Baltimore, Maryland Keith Moyer - (Keith.T.Moyer@medstar.net)
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Hermann Memorial City Medical Center Houston, Texas Maddie Peek - (maddie@whactc.com)
Midwest Cardiovascular Institute Naperville, Illinois Sherri McCoy - (Sherri.McCoy@cardio.com)
Mission Hospital Asheville, North Carolina Christina Riggsbee - (christina.riggsbee@hcahealthcare.com)
Mount Sinai Hospital New York, New York Joshua Wiener - (joshua.wiener@mountsinai.org)
North Mississippi Medical Center Tupelo, Mississippi Kristin Eads - (KEads@nmhs.net)
Northside Hospital, Inc Atlanta, Georgia Katie Moore - (katie.moore@northside.com)
Ohio Health Research Institute Columbus, Ohio
Pacific Heart Institute Santa Monica, California Stacy Chang - (research@pacificheart.com)
Piedmont Health Institute Atlanta, Georgia Caryn Bernstein - (caryn.bernstein@piedmont.org)
Pima Heart & Vascular Tucson, Arizona
Promedica Toledo Hospital Toledo, Ohio Sonya Inderrieden - (Sonya.Inderrieden@ProMedica.org)
Republican Specialized Center for Surgery named after V. Vakhidov Chilanzar, Tashkent
Saint Luke's Hospital of Kansas City Kansas City, Missouri Cheryl Rutherford - (cjrutherford@saint-lukes.org)
Sarasota Memorial Health Care System Sarasota, Florida Kristen Sangmaster - (kristen-sangmaster@smh.com)
Senatra Norfolk Norfolk, Virginia Linette Klevan - (LRKLEVAN@sentara.com)
St. Bernard's Medical Center Jonesboro, Arkansas Kayla Rubino - (krubino@dnairresearch.com)
Tbilisi Heart Center Tbilisi, Ketevan Gabunia, MD - (kgabunia@tbhc.ge)
Tbilisi Heart and Vascular Clinic Tbilisi, Natalia Cornea - (n.cornea@clinicalaccelerator.com) Teona Gamezardashvili - (t.gamezardashvili@clinicalaccelerator.com)
Tennova Healthcare - Turkey Creek Medical Center Knoxville, Tennessee Juliana Bailey - (juliana.bailey@tennova.com)
Terrebone - Cardiovascular Institute of the South Houma, Louisiana Jennifer Aucoin - (jennifer.aucoin@cardio.com)
TriHealth Cincinnati, Ohio Marta McClellan - (Marta_McClellan@trihealth.com)
Trident Medical Center Charleston, South Carolina Molly Harper - (Molly.Harper@hcahealthcare.com)
UPMC Harrisburg Mechanicsburg, Pennsylvania Matthew Rutt - (ruttmd4@upmc.edu)
USF - Tampa General Hospital Tampa, Florida Jacky He - (jackyhe@usf.edu)
University of Buffalo / Kaleida Health Buffalo, New York Cassandra Davern - (cadavern@buffalo.edu)
University of Iowa Iowa City, Iowa Trisha Elliott - (trisha-elliott@uiowa.edu)
University of Kansas Medical Center Kansas City, Kansas Grace Millington - (gmillington@kumc.edu)
Vanderbilt University Medical Center Nashville, Tennessee Amanda Caroll - (Amanda.carroll@vumc.org)
Virginia Commonwealth University Richmond, Virginia Esoterica Berry - (Esoterica.Berry@vcuhealth.org)
Wellstar Kennestone Hospital Marietta, Georgia Jennifer Cuvo - (Jennifer.Cuvo@wellstar.org)
West Virginia University Morgantown, West Virginia Marvin Hudson - (marvin.hudson1@wvumedicine.org)

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pociredir

Call Center - clinicaltrials@fulcrumtx.com

NCT05169580
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Key
Inclusion Criteria:
* Participant is 18 to 65 years of age, inclusive at the time informed consent is obtained. * Documented SCD at the time of screening (S/S, S/β0, S/β+, and S/C only) as confirmed through review of medical records or HPLC. * Participants who meet at least one the following criteria:
• ≥4 to 10 episodes of SCD pain crisis over 12 months, or ≥2 to 5 over 6 months prior to screening
• ≥2 episodes of SCD pain crisis plus at least one of the following over previous 12 months: i) Acute chest syndrome (ACS) ii. Hepatic or splenic sequestration iii. Priapism
• ≥2 of the following events over the previous 12 months:i. ACS ii. Hepatic or splenic sequestration iii. Priapism
• Tricuspid regurgitant jet velocity (TRV) ≥ 3.0 meter/second(m/s) OR TRV ≥ 2.5 m/s + N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma level ≥ 160 picogram per milliliter; OR documented ongoing pulmonary hypertension diagnosed from previous echocardiogram or right-sided heart catheterization with mean pulmonary artery pressure \> 25 millimeter of mercury;
• SCD-related chronic kidney disease (CKD)
• Meet medical criteria to receive (e.g., post-cerebrovascular accident) but are contraindicated for chronic transfusions (e.g., alloimmunization, transfusion reactions) * Previous experience with Hydroxyurea (HU) but have shown to be unresponsive and/or intolerant or ineligible AND * Previous experience with a stable dose of voxelotor, crizanlizumab, and/ or L-glutamine but have shown to be unresponsive and/or intolerant or ineligible * Per Investigator's recommendation, participants may continue crizanlizumab and/or L-glutamine but must be on a stable dose for at least 6 months * HbF ≤ 20% of total Hb * Total Hb ≥ 5.5 g/dL and ≤ 12 g/dl (males) or ≤ 10.6 g/dl (females) at screening. * Participant must meet both of the following laboratory values at screening:
• Absolute neutrophil count ≥ 1.5 × 10\^9 per liter (/l)
• Platelets ≥ 80 × 10\^9/l
• Absolute reticulocyte count at screening ≥ 100 x 10\^9/l. Key
Exclusion Criteria:
* Sickle cell complication requiring care from a medical provider in hospital or emergency care setting in the 14 days prior to starting study drug. * History of bone marrow transplant or human stem cell transplant or gene therapies. * • Participants with a history of severe renal disease defined as estimated glomerular filtration rate \< 30 mL/min/1.73m\^2. Participants on dialysis of any kind are excluded. * Participants receiving regularly scheduled transfusions or therapeutic phlebotomies, or any participant who has been transfused within 60 days prior to initiating study drug. * Participant with active malignancy, or history of cancer (except for squamous cell skin cancer, basal cell skin cancer, and stage 0 cervical carcinoma in situ, with no recurrence for the last 5 years), or has an immediate family member with known or suspected familial cancer syndrome. Known presence of a chromosomal abnormality or genetic mutation that may put the participant at an increased risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). * Participant currently on HU, or have received HU, within 60 days prior to initiating study drug.
DRUG: Pociredir oral capsule(s)
Sickle Cell Disease, Sickle Cell Anemia
Sickle Cell Disease, Sickle Cell Anemia, Pharmacokinetics, Pharmacodynamics, Pociredir, Open label
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Atlanta Center for Medical Research Atlanta, Georgia
Augusta University Augusta, Georgia
Axon Clinical Research Institute Baltimore, Maryland
Barau Dikko Teaching Hospital Kaduna,
Boston Medical Center Boston, Massachusetts
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg,
Eastern Carolina University Greenville, North Carolina
Foundation for Sickle Cell Disease Research, LLC Hollywood, Florida
Inova Schar Cancer Institute Fairfax, Virginia
Jacobi Medical Center The Bronx, New York
Lynn Health Science Institute Oklahoma City, Oklahoma
Mississippi Center for Advanced Medicine Madison, Mississippi
National Hospital, Abuja Abuja,
Our Lady of the Lake Hospital Baton Rouge, Louisiana
Queens Hospital Cancer Center Jamaica, New York
Sonar Research Center Atlanta, Georgia
University of Arkansas for Medical Sciences (UAMS) Little Rock, Arkansas
University of California, Los Angeles Los Angeles, California
University of Ibadan Ibadan,
University of Illinois Chicago Chicago, Illinois
University of Miami Health System Miami, Florida
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Texas Houston Houston, Texas
Virginia Commonwealth University Richmond, Virginia
Visionaries Clinical Research Atlanta, Georgia

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

ctrrecruit@vcu.edu

NCT06577441
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Inclusion Criteria:
* GENERAL MYLEOMATCH REGISTRATION CRITERIA: * Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \[g-CSF\], thrombopoietin \[TPO\] agonist), lenalidomide or luspatercept is allowed with a maximum limit of 1 month of exposure. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN) * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Enasidenib
Myelodysplastic Syndrome
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Study Locations

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Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Medical College of Wisconsin Milwaukee, Wisconsin
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mills Health Center San Mateo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Parkland Health Center - Farmington Farmington, Missouri
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
San Juan City Hospital San Juan,
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Chicago Medicine-Orland Park Orland Park, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
William S Middleton VA Medical Center Madison, Wisconsin

High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Brooke Burgess, MS - URCC_22053@urmc.rochester.edu

NCT05838716
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Inclusion Criteria:
* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed) * Be age 60 years or older * Be starting ADT or have received their first ADT treatment in the past 3 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted) * Have a total serum vitamin D between 10 and 27 ng/ml * Have a total serum calcium of less than or equal to 10.5 mg/dl * Have a normal GFR (glomerular filtration rate \> 30ml) * Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study * Be able to provide written informed consent * Be able to swallow pills and capsules * Be able to speak and read English
Exclusion Criteria:
* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment * Have a diagnosis of stage IV chronic kidney disease * Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl) * Have a history of hypercalcemia or vitamin D toxicity/sensitivity
PROCEDURE: Biospecimen Collection, DIETARY_SUPPLEMENT: D Vitamin, PROCEDURE: Dual X-ray Absorptiometry, DRUG: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
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Ballad Health Cancer Care - Bristol Bristol, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia Site Public Contact - (Anne_caramella@bshsi.org)
Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Francis Medical Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Mary's Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
CarolinaEast Medical Center New Bern, North Carolina Site Public Contact - (lharrison@carolinaeasthealth.com)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Saint Louis St Louis, Missouri
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Nash UNC HealthCare Rocky Mount, North Carolina
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
SMC Center for Hematology Oncology Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (melissa_beckman@bshsi.org)
Saint Francis Hospital Federal Way, Washington Site Public Contact - (melissa_beckman@bshsi.org)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - North Kansas City, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center-Overland Park Overland Park, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)

A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults

Nicholas Thomson - Nicholas.thomson@vcuhealth.org

NCT06239285
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Inclusion Criteria:
* violently injured patients from VCU's Level 1 Trauma Center * 18 years or older * English-speaking
Exclusion Criteria:
* Under 18 years old * Not a victim of Violent crime
DEVICE: Brief Violence Intervention VR (BVI-VR), OTHER: Treatment as Usual (TAU)
Violence
Firearm Violence Victim
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Virginia Commonwealth University Richmond, Virginia Nicholas Thomson - (nicholas.thomson@vcuhealth.org)

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)

Bayer Clinical Trials Contact - clinical-trials-contact@bayer.com

NCT06452277
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Inclusion Criteria:
* Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent. * Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC). * Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited. * No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening. * Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Exclusion Criteria:
* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance: * a. in situ cancers of cervix, breast, or skin, * b. superficial bladder cancer (Ta, Tis and T1), * c. limited-stage prostate cancer, * d. basal or squamous cancers of the skin. * Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD. * Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention. * Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0). * History of severe hypersensitivity reaction to treatment with a monoclonal antibody. * Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
DRUG: BAY2927088, DRUG: Pembrolizumab, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed
Advanced Non-small Cell Lung Cancer, HER2 Mutation
NSCLC, ERBB2 mutation
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?enry Durant Hospital Center-4th Oncology Department and Clinical Trials Unit Athens,
A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante São Paulo,
AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica Avellino, Campania
ASST Sette Laghi_Ospedale Macchi - Oncologia Varese,
AZ Delta | Clinical Trial Center - Pneumology Roeselare, West-Flanders
Aalborg University hospital - oncology department Aalborg,
Aarhus Universitetshospital Aarhus,
Adana Sehir Egitim ve Arastirma Hastanesi Yüreğir,
AdventHealth Cancer Institute Orlando, Florida
Allegheny General Hospital Pittsburgh, Pennsylvania
Ankara Bilkent Sehir Hastanesi Ankara,
Ankara Etlik Sehir Hastanesi Yenimahalle, Ankara
Antwerp University Hospital | Oncology Department Antwerp,
Assuta Ashdod Public Hospital (R.A) Ashdod,
Austin Hospital - Olivia Newton John Cancer Research Institute Heidelberg, Victoria
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica Palermo,
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica Bologna, Emilia-Romagna
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica Orbassano, Piedmont
BC Cancer - Vancouver Site Vancouver, British Columbia
Beacon Hospital Petaling Jaya,
Beijing Cancer Hospital - Oncology Department Beijing, Beijing Municipality
Beijing Chest Hospital, Capital Medical University Beijing,
Beijing Hospital Beijing, Beijing Municipality
Belfast City Hospital Belfast,
Bioclinic Thessaloniki Thessaloniki,
Blacktown Cancer & Haematology Centre Blacktown, New South Wales
Brampton Civic Hospital - Oncology Brampton, Ontario
Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály Budapest,
CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique Montpellier,
CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie Rouen,
CHULN - Hospital Pulido Valente Lisbon,
Calvary Mater Hospital Newcastle Waratah, New South Wales
Cancer Hospital, Chinese Academy of Medical Sciences Beijing,
CardioMed S.R.L. Cluj-Napoca,
Careggi University Hospital - Oncologia Clinica Florence,
Careggi University Hospital - Oncologia Clinica Florence,
Centre Antoine Lacassagne - Departement Oncologie Nice,
Centre Hospitalier Intercommunal Creteil - Service de pneumologie Créteil,
Centre Hospitalier Michallon Grenoble - Service pneumologie La Tronche,
Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique Limoges,
Centro Médico Privado CEMAIC Córdoba,
Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima São Paulo,
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia Verona,
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) Buenos Aires,
Centro de Investigaciones Clínicas, Clínica Viedma Viedma,
Centro de Pesquisa da Clínica de Oncologia Reichow Blumenau, Santa Catarina
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati Aviano, Friuli Venezia Giulia
Centrul de Oncologie Sfantul Nectarie Craiova,
Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Berlin,
Chi-Mei Medical Center, Liouyine Tainan City,
Chonnam National University Hwasun Hospital Hwasun-gun,
Chung Shan Medical University Hospital Taichung,
Chungbuk National University Hospital Chungju,
Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona,
Clinica Integral Internacional de Oncologia S. de R.L. de C.V. Puebla City,
Columbia Asia Hospital Bukit Rimau Shah Alam, Selangor
Complejo Hospitalario Universitario A Coruña (CHUAC) A Coruña,
Complex Oncology Center - Plovdiv EOOD Plovdiv,
Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit Concord, New South Wales
Curie Oncology | Farrer Singapore,
Docrates Mehiläinen Syöpäsairaala Helsinki, Uusimaa
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw,
Ege Universitesi Tip Fakultesi Izmir,
Fakultna Nemocnica Trnava Trnava,
Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy Olomouc,
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 Milan, Lombardy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare Rome, Lazio
Fujian Cancer Hospital Fuzhou, Fujian
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica Lisbon,
Fundacion Instituto Valenciano de Oncologia (IVO Valencia,
Fundación CENIT para la Investigación en Neurociencias Ciudad Autonoma Buenos Aires,
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo
General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA Athens,
Gleneagles Penang Medical Center George Town,
Guangxi Medical University (GXMU) - Affiliated Tumor Hospital Nanning,
Guangzhou Medical University - The First Affiliated Hospital Guangzhou,
Gustave Roussy - Departement Oncologie-Radiotherapie Villejuif,
Gyeongsang National University Hospital Jinju, Gyeongsangnam-do
HFR Freiburg - Kantonsspital Fribourg,
Harbin Medical University Cancer Hospital Harbin, Heilongjiang
Hokkaido University Hospital Hokkaido, Sapporo,
Hong Kong United Oncology Centre Kowloon,
Hopital Foch - Oncologie digestive et thoracique Suresnes,
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie Brest,
Hopital Nord Laennec - Oncologie medicale thoracique et digestive Nantes,
Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Barcelona,
Hospital General Universitario Gregorio Marañón | Oncología Madrid,
Hospital Pedro Hispano | Clinical Research Center Matosinhos Municipality, Porto District
Hospital Quiron Dexeus - Oncologia Barcelona,
Hospital Sirio Libanes São Paulo,
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia Brasília,
Hospital Universitario De Navarra - Oncologia Pamplona,
Hospital Universitario Fundacion Jimenez Diaz- Oncology Service Madrid,
Hospital Universitario Puerta De Hierro De Majadahonda - Oncologia Majadahonda, Madrid
Hospital Universitario Ramon Y Cajal - Oncologia Madrid,
Hospital Universitario Y Politecnico La Fe - Oncologia Valencia,
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia Nuevo León,
Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia São José do Rio Preto, São Paulo
Hubei Cancer Hospital Wuhan,
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia Rozzano, Lombardy
Hunan Cancer Hospital - Oncology Department Changsha, Hunan
I.A.Ü. VM Medical Park Florya Hastanesi Küçükçekmece,
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2 Rome, Lazio
IPO Porto Porto,
Institut Bergonié - Unicancer Nouvelle Aquitaine Bordeaux,
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location Badalona,
Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire Lille,
Institut Curie - Paris - Oncologie medicale Paris,
Institut de Cancerologie Ouest - Saint-Herblain Saint-Herblain,
Instituto Argentino de Diagnostico y Tratamiento (IADT) TBC,
Instituto Nacional De Cancerologia Bogota, Cundinamarca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II Bucharest,
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca,
Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology Porto Alegre, Rio Grande do Sul
Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi Kadıköy,
Istituto Europeo di Oncologia s.r.l - Oncologia Toracica Milan, Lombardy
Istituto Oncologico Veneto_Padova - UOC Oncologia 2 Padua, Veneto
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica Meldola, Emilia-Romagna
Jewish General Hospital - Department of Pulmonary Oncology Montreal, Quebec
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University Nanjing,
Jilin Cancer Hospital Changchun,
John B. Amos Cancer Center Columbus, Georgia
Kansai Medical University Hospital Hirakata, Osaka
Kantonsspital Baden Baden,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Kindai University Hospital Sayama, Osaka
Kitasato University Hospital Sagamihara, Kanagawa
Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik Vienna,
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik Cologne, North Rhine-Westphalia
Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde) Nuremberg,
Kobe University Hospital Kobe, Hyōgo
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabánya,
Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie Zlín, Zlín
Kyiv City Clinical Oncology Center - Department of Chemotherapy #1 Kyiv,
LLC "RDP Ukraine" - Medical Department Dnipro,
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal, Rio Grande do Norte
Limited Liability Company "MedOffice Group Medical Center" Kyiv,
LinYi Cancer Hospital (Linyi Tumor Hospital) Linyi,
Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin Hemer,
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center Minneapolis, Minnesota
MHAT "Heart and brain" Pleven Pleven,
MHAT Park Hospital EOOD Plovdiv,
MHAT Serdika Sofia,
MHAT Sveta Marina EAD Varna,
MHAT Uni Hospital Panagyurishte, Pazardzhik
MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department Uzhhorod,
Marmara University Hospital Istanbul,
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP) Brno,
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku Otwock,
Medical Center LLC "Verum Expert Clinic" Kyiv,
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie Vienna,
Memorial Cancer Institute at Miramar Miramar, Florida
Metropolitan Hospital- 4th Oncology Clinic Piraeus,
Moffitt Cancer Center Tampa, Florida
Moffitt Cancer Center - Magnolia Campus Tampa, Florida
Multiprofile Hospital for Active Treatment "Sveta Sofia" Sofia,
Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department Rivne,
NAIC - Instituto do Cancer Bauru,
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, Jiangsu
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej Warsaw, Masovian Voivodeship
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej Warsaw, Masovian Voivodeship
National Cancer Center Hospital East Chiba, Kashiwa,
National Cheng Kung University Hospital Tainan,
National Hospital Organization Himeji Medical Center Himeji-Shi, Hyōgo
National Hospital Organization Kyushu Medical Center Fukuoka, Fukuoka
National Hospital Organization Nagoya Medical Center Nagoya, Aichi-ken
National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital) Ube, Yamaguchi
National Taiwan University Hospital Taipei,
National Taiwan University Hospital (NTUH) - Cancer Research Center Taipei,
Nederlands Kanker Instituut Amsterdam,
Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologie Nový Jicín,
Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddelení Ostrava - Vítkovice,
Niigata Cancer Center Hospital Niigata,
Nippon Medical School - Nippon Medical School Hospital - Cancer Center Bunkyo-ku, Tokyo
Norrland University Hospital - Cancercentrum Umeå,
ONCARE Treatment Center San Pedro Garza García,
Odense University Hospital - Oncology Department Odense C,
Oncare Viaducto Nápoles Mexico City,
OncoCare Cancer Centre | Gleneagles Medical Centre Singapore,
Oncocenter Puebla City,
Oncologia Integral Satelite Naucalpan,
Osaka International Cancer Institute Osaka, Osaka,
Ospedale San Raffaele s.r.l. - Oncologia Medica Milan,
Ospedale Vito Fazzi Lecce - Oncologia Lecce,
PAPANIKOLAOU General Hospital of Thessaloniki Thessaloniki,
POKO Poprad s.r.o. Poprad,
Patty & George Hoag Cancer Center Newport Beach, California
Piedmont Cancer Institute - Atlanta Atlanta, Georgia
Prince of Wales Hospital Grimsby,
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology Toronto, Ontario
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center Kropyvnytskyi,
Profound Research - OMG - Royal Oak Cancer Center Royal Oak, Michigan
Profound Research -OMG - TriAtria Cancer Center Farmington Hills, Michigan
Pronutrir Fortaleza - CE Fortaleza,
Providence Cancer Institute - Franz Clinic Portland, Oregon
Providence Oncology and Hematology Care Clinic Westside Portland, Oregon
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do
Queen Elizabeth Hospital Hong Kong Hong Kong,
Queen Mary Hospital Hong Kong,
R.J. Zuckerberg Cancer Center New Hyde Park, New York
Radboud University Medical Center | Afdeling Interne Geneeskunde Nijmegen,
Radiotherapy Center Cluj SRL Flore?ti, Comuna Floresti
Raffles Cancer Centre Singapore,
Rede DoR Recife - PE Recife, Pernambuco
Regionshospitalet Gødstrup - Medicinsk afdeling Herning,
Rigshospitalet - Kræftbehandling Copenhagen OE,
Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin Stuttgart,
Royal Surrey County Hospital Guildford, Surrey
S.C Ovidius Clinical Hospital SRL - Oncology Department Ovidiu,
Saitama Cancer Center Kitaadachi-gun, Saitama
Sakarya Universitesi Egitim ve Arastirma Hastanesi Sakarya,
Samsung Medical Center - Oncology Department Seoul,
Sc Oncolab Srl Craiova, Dolj
Sendai Kousei Hospital Miyagi,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System - Oncology Department Seoul, Seoul Teugbyeolsi
Shaare Zedek Medical Center (SZMC) Jerusalem,
Shandong University - Shandong Cancer Hospital Jinan,
Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai, Shanghai Municipality
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department Hangzhou, Zhejiang
Skane University Hospital Lund, Skåne County
Soroka Medical Center- Legacy Heritage Cancer Center Beersheba,
Specialized Hospital for Active Treatment of Oncology Sofia,
Spitalul Clinic Coltea Bucharest,
Sunway Medical Centre Subang Jaya, Selangor
Sunway Medical Centre Penang Perai,
Swietokrzyskie Centrum Onkologii Kielce,
Taichung Veterans General Hospital Taichung, China
Taipei Veterans General Hospital Taipei, Beitou District / R.o.c.
Tan Tock Seng Hospital Singapore,
Tel-Aviv Sourasky Medical Center Tel Aviv,
The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC) Garran,
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street Fort Lauderdale, Florida
The People's Liberation Army General Hospital (Beijing 301 Hospital) Beijing,
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology Chicago, Illinois
The University of Texas MD Anderson Cancer Center - Texas Medical Center Houston, Texas
Torbay Hospital Torquay,
Tottori University Hospital Yonago, Tottori
Turun Yliopistollinen keskussairaala Turku,
UC Medical Center - Oncology Cincinnati, Ohio
UC San Diego Health - Moores Cancer Center San Diego, California
UCLA Health Santa Monica Cancer Care Santa Monica, California
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology San Francisco, California
UM Greenebaum Comprehensive Cancer Center Baltimore, Maryland
UMass Memorial Medical Center - University Campus - Hematology/Oncology Worcester, Massachusetts
UZ Leuven Gasthuisberg - Pneumology Department Leuven, Vlaams-Brabant
Unidade Local Saúde Coimbra, E.P.E Coimbra,
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III Salzburg,
Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde Salzburg,
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech Wuhan, Hubei
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung) Essen, North Rhine-Westphalia
Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie Giessen, Hesse
University General Hospital ATTIKON, Department of Internal Medicine IV Chaïdári,
University General Hospital of Athens "ATTIKON" Chaïdári,
University General Hospital of Larissa Larissa,
University Hospital Kebangsaan Malaysia Cheras,
University Hospital Simmons Cancer Center Lung/Head Neck Clinic Dallas, Texas
University Malaya Medical Centre Kuala Lumpur,
University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia Sofia,
University of Athens Medical School-Sotiria General Hospital - 3rd Dept of Medicine & Medical Oncology Athens,
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital) Chengdu, Sichuan
University of Illinois Hospital - Outpatient Cancer Care Center Chicago, Illinois
University of the Sunshine Coast Sippy Downs, Queensland
Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie Frankfurt,
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi Lodz,
Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok,
Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials Unit Cardiff,
Virginia Commonwealth University Richmond, Virginia
Volyn Regional Oncology Center Lutsk,
West China Hospital Sichuan University Chengdu, Sichuan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan,
Xiamen University - The First Affiliated Hospital Xiamen,
Zhejiang Cancer Hospital Zhejiang,
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province Taizhou, Zhejiang
Zhongshan Hospital, Fudan University - Oncology Department Shanghai,
hopital Emile Muller - Service Pneumologie Mulhouse,
hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique Pierre-Bénite,
hopital cochin APHP - service de pneumologie Paris,
hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires,

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Toll Free Number - Trialsites@msd.com

NCT06136559
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy. * Has at least 1 marker of disease burden. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization. * Has the ability to swallow and retain oral medication. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening. * Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection. * Has gastrointestinal (GI) dysfunction that may affect drug absorption. * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL. * Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening. * Has clinically significant cardiovascular disease. * Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients. * Has history of severe bleeding disorder. * Has known additional malignancy that is progressing or has required active treatment within the past 2 years. * Has received any systemic anticancer therapy for CLL/SLL. * Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors. * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration. * Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
DRUG: Nemtabrutinib, DRUG: Ibrutinib, DRUG: Acalabrutinib
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Study Locations

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AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205) Mechelen, Antwerpen
Aalborg Universitetshospital, Syd ( Site 0403) Aalborg, North Denmark
Akershus Universitetssykehus ( Site 0902) Lørenskog, Akershus
Alta Bates Summit Medical Center ( Site 0004) Berkeley, California
Anhui Provincial Cancer Hospital ( Site 2001) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407) Ankara,
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401) Ankara,
Antalya Egitim ve Arastırma Hastanesi ( Site 1409) Antalya,
Aotearoa Clinical Trials ( Site 3201) Auckland,
Arizona Oncology Associates - NAHOA ( Site 8007) Prescott, Arizona
BC Cancer Kelowna ( Site 0112) Kelowna, British Columbia
BC Cancer Victoria ( Site 0109) Victoria, British Columbia
Barnet Hospital ( Site 3005) Barnet,
Bnai Zion Medical Center ( Site 1505) Haifa,
Bradfordhill-Clinical Area ( Site 2310) Santiago, Region M. de Santiago
Cancer Care Associates Of York ( Site 0005) York, Pennsylvania
Cancer Institute Hospital of JFCR ( Site 1906) Koto, Tokyo
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100) Rimouski, Quebec
Centro Medico Monte Carmelo-Oncology ( Site 2706) Arequipa, Ariqipa
Centro de Infusion Superare ( Site 2602) Mexico City, Mexico City
Champalimaud Foundation ( Site 3102) Lisbon, Lisbon District
Chang Gung Medical Foundation-Linkou Branch ( Site 1703) Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702) Kaohsiung City,
Chiba Cancer Center ( Site 1905) Chiba,
Chongqing University Cancer Hospital ( Site 2041) Chongqing, Chongqing Municipality
Chulalongkorn University ( Site 1802) Bangkok, Bangkok
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003) Nottingham,
Clermont Oncology Center ( Site 0046) Clermont, Florida
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306) Santiago, Region M. de Santiago
Clínica Anglo Americana ( Site 2701) Lima,
Constantiaberg Haematology ( Site 1106) Plumstead, Western Cape
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall, Pennsylvania
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids, Michigan
Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich, Connecticut
Ege Universitesi Hastanesi ( Site 1404) Izmir,
Evangelismos General Hospital of Athens ( Site 0700) Athens, Attica
FALP-UIDO ( Site 2300) Santiago, Region M. de Santiago
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801) Bangkok, Bangkok
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301) Hradec Králové,
Fakultni nemocnice Olomouc ( Site 0303) Olomouc,
Florida Cancer Specialists - East ( Site 7002) West Palm Beach, Florida
Florida Cancer Specialists - South ( Site 7001) Fort Myers, Florida
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402) Cali, Valle del Cauca Department
Galilee Medical Center ( Site 1507) Nahariya,
General Hospital of Athens "Laiko" ( Site 0704) Athens, Attica
GenesisCare - Bristol ( Site 3011) Bristol, South Gloucestershire
GenesisCare - Cambridge ( Site 3001) Newmarket, Suffolk
GenesisCare - Windsor ( Site 3002) Windsor, Windsor And Maidenhead
Groote Schuur Hospital-Clinical Haematology ( Site 1100) Cape Town, Western Cape
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) Nanning, Guangxi
Gunma University Hospital ( Site 1903) Maebashi, Gunma
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202) Barcelona, Catalonia
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208) Majadahonda, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209) Pozuelo de Alarcón, Madrid
Hadassah Medical Center-Hemato-Oncology ( Site 1500) Jerusalem,
Haemalife ( Site 1105) Kuilsriver, Western Cape
Hainan General Hospital ( Site 2018) Haikou, Hainan
Health Pharma Professional Research S.A. de C.V: ( Site 2608) Mexico City, Mexico City
Henan Cancer Hospital-hematology department ( Site 2025) Zhengzhou, Henan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913) Hiroshima,
Hokkaido University Hospital ( Site 1900) Sapporo, Hokkaido
Hospital 9 De Julho ( Site 2206) São Paulo, São Paulo
Hospital Paulistano-Americas Oncologia ( Site 2202) São Paulo,
Hospital Pulau Pinang ( Site 1602) George Town, Pulau Pinang
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206) Barcelona,
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201) Salamanca,
Hunan Cancer Hospital ( Site 2020) Changsha, Hunan
IMAT S.A.S ( Site 2401) Montería, Departamento de Córdoba
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606) Koblenz, Rhineland-Palatinate
Inova Schar Cancer Institute ( Site 0015) Fairfax, Virginia
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207) L'Hospitalet Del Llobregat, Barcelona
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005) Tianjin, Tianjin Municipality
Instituto Nacional de Câncer - INCA ( Site 2201) Rio de Janeiro,
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103) Lisbon, Lisbon District
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100) Porto,
Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction, Colorado
Japanese Red Cross Osaka Hospital ( Site 1908) Osaka,
Jiangsu Province Hospital ( Site 2000) Nanjing, Jiangsu
Jiangxi Provincial Cancer Hospital ( Site 2009) Nanchang, Jiangxi
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack, New Jersey
Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County
Kindai University Hospital ( Site 1909) Sakai, Osaka
Kliniken Maria Hilf ( Site 0603) Mönchengladbach, North Rhine-Westphalia
Kobe City Medical Center General Hospital ( Site 1910) Kobe, Hyōgo
Kyushu University Hospital ( Site 1914) Fukuoka,
Liuzhou People's Hospital ( Site 2029) Liuzhou, Guangxi
Lutheran Medical Center ( Site 0027) Golden, Colorado
Maharaj Nakorn Chiang Mai Hospital ( Site 1800) Muang, Chiang Mai
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408) Istanbul,
McGill University Health Centre ( Site 0106) Montreal, Quebec
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010) Spokane, Washington
Mega Medipol ( Site 1412) Istanbul,
MidAmerica Cancer Care, LLC ( Site 0043) Kansas City, Missouri
Moores Cancer Center ( Site 0003) La Jolla, California
Nagoya University Hospital ( Site 1907) Nagoya, Aichi-ken
Naresuan University Hospital ( Site 1804) Muang, Changwat Phitsanulok
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004) Warsaw, Masovian Voivodeship
National Cheng Kung University Hospital ( Site 1700) Tainan,
National Taiwan University Hospital ( Site 1701) Taipei,
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101) Pretoria, Gauteng
North Shore Hospital-Department of Haematology ( Site 3200) Auckland,
Odense Universitetshospital-Department of Hematology ( Site 0401) Odense C, Region Syddanmark
Okayama University Hospital ( Site 1912) Okayama,
Oncology Specialists of Charlotte ( Site 0054) Charlotte, North Carolina
Ondokuz Mays Üniversitesi ( Site 1410) Samsun,
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600) Berlin,
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901) Oslo,
Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne, Indiana
Peking University First Hospital ( Site 2022) Beijing, Beijing Municipality
Peking University Third Hospital-Hematology ( Site 2011) Beijing, Beijing Municipality
Pratia MCM Krakow ( Site 1007) Krakow, Lesser Poland Voivodeship
Pratia Onkologia Katowice ( Site 1009) Katowice, Silesian Voivodeship
Queen Elizabeth Hospital ( Site 1603) Kota Kinabalu, Sabah
Queen Mary Hospital ( Site 3300) Hong Kong,
Rabin Medical Center ( Site 1504) Petah Tikva,
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503) Haifa,
Regions Hospital ( Site 0042) Saint Louis Park, Minnesota
Roskilde Sygehus-Department of Hematology ( Site 0402) Roskilde, Region Sjælland
Roswell Park Cancer Institute ( Site 0023) Buffalo, New York
Royal Lancaster Infirmary ( Site 3012) Lancaster, Lancashire
Royal North Shore Hospital ( Site 2806) St Leonards, New South Wales
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048) Madison, Wisconsin
Saint Elizabeth Healthcare ( Site 0041) Edgewood, Kentucky
Saint Joseph Hospital ( Site 0026) Denver, Colorado
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005) Olsztyn, Warmian-Masurian Voivodeship
Shaanxi provincial people's hospital ( Site 2012) Xi'an, Shaanxi
Shandong Cancer Hospital ( Site 2003) Jinan, Shandong
Shanxi Cancer Hospital ( Site 2033) Taiyuan, Shanxi
Sheba Medical Center-Hemato Oncology ( Site 1501) Ramat Gan,
Shimane University Hospital ( Site 1911) Izumo, Shimane
Sisli Florence Nightingale Hastanesi ( Site 1411) Istanbul,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405) Valledupar, Cesar Department
Songklanagarind hospital ( Site 1803) Hat Yai, Changwat Songkhla
Southeastern Medical Oncology Center ( Site 0049) Goldsboro, North Carolina
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) Guangzhou, Guangdong
Southmead Hospital ( Site 3010) Bristol, Bristol, City of
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006) London, London, City of
St James's University Hospital ( Site 3004) Leeds,
Summit Medical Group Cancer Center ( Site 0007) Florham Park, New Jersey
Sun Yat-sen University Cancer Center ( Site 2028) Guangzhou, Guangdong
Sykehuset i Vestfold ( Site 0903) Tønsberg, Vestfold
TENNESSEE ONCOLOGY ( Site 0031) Nashville, Tennessee
Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga, Tennessee
Texas Oncology - Central/South Texas ( Site 8008) Austin, Texas
Texas Oncology - Northeast Texas ( Site 8012) Tyler, Texas
Texas Oncology - San Antonio ( Site 8006) San Antonio, Texas
The Affiliated Hospital of Guizhou Medical University ( Site 2024) Guiyang, Guizhou
The Affiliated Hospital of Xuzhou Medical College ( Site 2013) Xuzhou, Jiangsu
The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth, Texas
The Churchill Hospital ( Site 3007) Oxford, Oxfordshire
The First Affiliated Hospital of Nanchang University ( Site 2023) Nanchang, Jiangxi
The First Affliated Hospital of Suzhou University ( Site 2027) Suzhou, Jiangsu
The First Hospital of Jilin University-Hematology ( Site 2030) Changchun, Jilin
The Ottawa Hospital - General Campus ( Site 0102) Ottawa, Ontario
The Second Xiangya Hospital of Central South University ( Site 2010) Changsha, Hunan
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002) Hangzhou, Zhejiang
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019) Tianjin, Tianjin Municipality
Tohoku University Hospital ( Site 1901) Sendai, Miyagi
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016) Wuhan, Hubei
Trakya University-Balkan Onkoloji Hastanesi ( Site 1403) Edirne,
USA Mitchell Cancer Institute ( Site 0014) Mobile, Alabama
UZ Leuven-Hematology ( Site 0200) Leuven, Vlaams-Brabant
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107) Vila Nova de Gaia, Porto District
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104) Lisbon,
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106) Lisbon,
Universitaetsklinikum Ulm. ( Site 0601) Ulm, Baden-Wurttemberg
University Hospital and UW Health Clinics ( Site 0006) Madison, Wisconsin
University Hospital of Alexandroupolis ( Site 0701) Alexandroupoli, East Macedonia and Thrace
University Hospital of Ioannina ( Site 0702) Ioannina,
University Malaya Medical Centre ( Site 1604) Lembah Pantai, Kuala Lumpur
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017) Iowa City, Iowa
University of Virginia Cancer Center ( Site 0040) Charlottesville, Virginia
Universitätsklinikum Halle ( Site 0604) Halle, Saxony-Anhalt
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006) Lublin, Lublin Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011) Gdansk, Pomeranian Voivodeship
VK&K Studien GbR ( Site 0607) Landshut, Bavaria
Virginia Commonwealth University (VCU) Medical Center ( Site 0030) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) Prague,
Waikato Hospital-Haematology ( Site 3202) Hamilton, Waikato Region
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026) Chengdu, Sichuan
William Osler Health System ( Site 0103) Brampton, Ontario
Wits Clinical Research ( Site 1102) Johannesburg, Gauteng
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013) Słupsk, Pomeranian Voivodeship
Wuhan Union Hospital ( Site 2015) Wuhan, Hebei
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014) Ürümqi, Xinjiang
Yamagata University Hospital ( Site 1902) Yamagata,
Yitzhak Shamir Medical Center. ( Site 1506) Ẕerifin,
Zhejiang Cancer Hospital ( Site 2017) Hangzhou, Zhejiang
hospital universitario de canarias ( Site 1205) San Cristóbal de La Laguna, Santa Cruz De Tenerife

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME)

Immatics US, Inc. - ctgovinquiries@immatics.com

NCT06743126
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Inclusion Criteria:
* Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma * Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.
Exclusion Criteria:
* Primary mucosal or uveal melanoma and melanoma of unknown primary * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents. * History of cardiac conditions as per protocol * Prior allogenic stem cell transplantation or solid organ transplantation * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician * History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs * Known hypersensitivity to any of the rescue medications * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Any condition contraindicating leukapheresis * Pregnant or breastfeeding * Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment) * Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis, * Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis. * Patients with any active infection or ongoing reactivation of infection * Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months * Prior treatment with IMA203 * Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months * Patients with LDH greater than 2.0-fold ULN * Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment * Patients with active brain metastases or leptomeningeal metastases * Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization * Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment * Other protocol defined inclusion/exclusion criteria could apply
BIOLOGICAL: IMA203, BIOLOGICAL: nivolumab plus relatlimab, BIOLOGICAL: lifileucel, BIOLOGICAL: nivolumab, BIOLOGICAL: pembrolizumab, BIOLOGICAL: ipilimumab, DRUG: Dacarbazine, DRUG: temozolomide, DRUG: paclitaxel, DRUG: paclitaxel plus carboplatin, DRUG: Albumin-Bound Paclitaxel
Melanoma, Cutaneous Malignant
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Location Contacts
Atlantic Health System/Morristown Medical Center Morristown, New Jersey
Avera Cancer Institute Sioux Falls, South Dakota Benjamin Solomon, MD - (Benjamin.Solomon@avera.org)
Baylor University Dallas, Texas
Charite Universitaetsmedizin Berlin KöR Berlin,
City of Hope National Medical Center Duarte, California Yan Xing, MD - (yxing@coh.org)
Cleveland Clinic, Taussig Cancer Institute Cleveland, Ohio James Isaac - (isaacsj3@ccf.org)
Fox Chase Cancer Center Philadelphia, Pennsylvania Anthony J Olszanski, MD, RPh - (Anthony.Olszanski@FCCC.edu)
Fred Hutchinson Cancer Center Seattle, Washington Sylvia Lee, MD - (leesm@uw.edu)
Goethe University Frankfurt Frankfurt am Main,
Honor Health Research Institute Scottsdale, Arizona Justin Moser, MD - (jmoser@honorhealth.com)
Huntsman Cancer Institute, University of Utah Salt Lake City, Utah Siwen Hu-Lieskovan, MD, PhD - (Siwen.Hu-Leiskovan@hci.utah.edu)
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health New York, New York Maya Dimitrova, MD - (maya.dimitrova@nyulangone.org)
Massachusetts General Hospital Boston, Massachusetts
Memorial Sloan Kettering Cancer Center New York, New York James Smithy, MD - (smithyj@mskcc.org)
Moffitt Cancer Center Tampa, Florida
Ohio State University Columbus, Ohio
Providence Cancer Institute Franz Clinic Portland, Oregon Matthew Taylor, MD - (Matthew.Taylor@providence.org)
SCRI Oncology Partners Nashville, Tennessee
Stanford Cancer Center Palo Alto, California Alison Betof Warner, MD, PhD - (allison.betof@stanford.edu)
Technische Universitaet Dresden Dresden,
The University of Texas MD Anderson Cancer Center Houston, Texas Rodabe N Amaria, MD - (RNAmaria@mdanderson.org)
Thomas Jeffersion University, Sidney Kimmel Cancer Center Philadelphia, Pennsylvania
UCLA Hematology/Oncology Los Angeles, California Bartosz Chmielowski, MD, PhD - (bchmielowski@mednet.ucla.edu)
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill, North Carolina Stergios Moschos, MD - (stergios_moschos@med.unc.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania Jason J Luke, M.D. - (lukejj@upmc.edu)
Universitaet Leipzig Leipzig,
Universitaetsklinikum Bonn AöR Bonn,
Universitaetsklinikum Erlangen AöR Erlangen,
Universitaetsklinikum Essen AöR Essen,
Universitaetsklinikum Heidelberg AöR Heidelberg,
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Mainz,
University Hospital Cologne AöR Cologne,
University Medical Center Hamburg-Eppendorf Hamburg, City state of Hamburg
University of MD Greenebaum Comprehensive Cancer Center Baltimore, Maryland Petra Hausner, MD, PhD - (phausner@umm.edu)
University of Miami - Sylvester Comprehensive Cancer Cente Miami, Florida Leonel Hernandez-Aya, MD - (l.hernandezaya@med.miami.edu)
University of Nebraska Medical Center Omaha, Nebraska Bhavina Sharma, MD - (bhsharma@unmc.edu)
University of Pennsylvania, Abramson Cancer Center Philadelphia, Pennsylvania
University of Texas Southwestern Medical Center Dallas, Texas Sanjay Chandrasekaran, MD - (Sanjay.Chandrasekaran@utsouthwestern.edu)
Virginia Commonwealth University Richmond, Virginia Andrew Poklepovic, MD - (andrew.poklepovic@vcuhealth.org)
Yale Cancer Center New Haven, Connecticut

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Director Regulatory Affairs - langerj@nrgoncology.org

NCT05896189
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Inclusion Criteria:
* The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. * The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. * The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. * Participants must be at least 6 months and no more than 5 years (after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy). Participants may still be taking endocrine therapy and/or trastuzumab. * The participant must be able to understand, speak, read, and write in English or Spanish.
Exclusion Criteria:
* Scoring less than or equal to 3 on the 6-item cognitive screen. * Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. * Definitive clinical or radiologic evidence of metastatic disease. * Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible. * Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). * Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. * Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. * Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability. * Participants who are enrolled in an active behavioral intervention (e.g., occupational therapy, physical therapy, etc.) or pharmaceutical intervention or who are in the follow-up phase of a cancer control trial or therapeutic trial that has extensive PRO follow-up after treatment ends. Participants who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and/or survival analysis (cancer-related mortality or all-cause mortality) would be eligible. * Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.
BEHAVIORAL: Arm 1: Computerized Cognitive Training-Global Stimulation Games, BEHAVIORAL: Arm 2: Computerized Cognitive Training-Neuroplasticity Games
Breast Cancer, Cognitive Impairments
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AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Addison Gilbert Hospital Gloucester, Massachusetts
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advanced Breast Care Center PLLC Warren, Michigan
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Mercy Hospital Council Bluffs, Iowa
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
AnMed Health Cancer Center Anderson, South Carolina Site Public Contact - (rhonda.ballew@anmedhealth.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Radiation Therapy Center Anchorage, Alaska
Annie Penn Memorial Hospital Reidsville, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Arizona Center for Cancer Care Tempe, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care - Biltmore Phoenix, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care - Gilbert Gilbert, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care - Osborn Scottsdale, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care - Phoenix Phoenix, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care - Scottsdale Scottsdale, Arizona Site Public Contact - (penny.labriola@arizonaccc.com)
Arizona Center for Cancer Care-Peoria Peoria, Arizona
Arizona Center for Cancer Care-Surprise Surprise, Arizona Site Public Contact - (Roster@nrgoncology.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Ascension Borgess Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Borgess Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Via Christi Hospitals Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
BASS Medical Group - Lennon Walnut Creek, California Site Public Contact - (brenna.lindsey@bassmedicalgroup.com)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital for Women Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Beverly Hospital Beverly, Massachusetts
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Blanchard Valley Hospital Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia Site Public Contact - (Anne_caramella@bshsi.org)
Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Richmond Community Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Francis Medical Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Mary's Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Westchester Emergency Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Boulder Community Foothills Hospital Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
Broward Health North Deerfield Beach, Florida
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Health Saint Francis Grand Island, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CTCA at Southeastern Regional Medical Center Newnan, Georgia
CTCA at Western Regional Medical Center Goodyear, Arizona
Cancer Care Associates PC Royal Oak, Michigan
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Kansas - Chanute Chanute, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Dodge City Dodge City, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - El Dorado El Dorado, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - McPherson McPherson, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Newton Newton, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Parsons Parsons, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Pratt Pratt, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Salina Salina, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Wellington Wellington, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Winfield Winfield, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Independence Independence, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Kingman Kingman, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Liberal Liberal, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Center-Metro Medical Center Bayamon Bayamón,
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan
Castle Medical Center Kailua, Hawaii Site Public Contact - (Roster@nrgoncology.org)
Cedars Sinai Medical Center Los Angeles, California
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (Roster@nrgoncology.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Chester County Hospital West Chester, Pennsylvania Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Akron General Akron, Ohio Site Public Contact - (CancerAnswer@ccf.org)
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Colorado Blood Cancer Institute Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Comprehensive Medical Center PLLC Royal Oak, Michigan
Cone Health Cancer Center Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Alamance Regional Burlington, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Asheboro Asheboro, North Carolina
Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health MedCenter Asheboro Asheboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Contra Costa Regional Medical Center Martinez, California
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC - Englewood Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC - Troy Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Miami Valley South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Wayne Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Doctors Cancer Center Manatí,
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Englewood Hospital and Medical Center Englewood, New Jersey
Enloe Medical Center Chico, California
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
FMH James M Stockman Cancer Institute Frederick, Maryland
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Frederick Memorial Hospital Frederick, Maryland
Frederick Memorial Hospital Crestwood Frederick, Maryland Site Public Contact - (ctsucontact@westat.com)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Freeman Physician Group of Pittsburg Pittsburg, Kansas Site Public Contact - (BNMathew@freemanhealth.com)
Fremont - Rideout Cancer Center Marysville, California
Fresno Cancer Center Fresno, California Site Public Contact - (Kpoct@kp.org)
Garnet Health Medical Center Middletown, New York Site Public Contact - (jgerlach@garnethealth.org)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Selinsgrove Selinsgrove, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
George Washington University Medical Center Washington D.C., District of Columbia
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Goshen Center for Cancer Care Goshen, Indiana Site Public Contact - (cccois@goshenhealth.com)
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Halifax Health Medical Center-Centers for Oncology Daytona Beach, Florida
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Hawaii Diagnostic Radiology Services LLC Honolulu, Hawaii Site Public Contact - (mmiyoshi@hawaiidrs.com)
HaysMed Hays, Kansas
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-Auburn Auburn, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hematology Oncology Consultants PC-Royal Oak Royal Oak, Michigan
Hematology Oncology Consultants PC-Troy Troy, Michigan
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Cancer Institute-Downriver Brownstown, Michigan
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford River District Hospital East China Township, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - GLCMS Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jackson Oncology Associates PLLC Jackson, Mississippi
Jefferson Healthcare Port Townsend, Washington
Jersey Shore Medical Center Neptune City, New Jersey
John Fitzgerald Kennedy Medical Center Atlantis, Florida
John H Stroger Jr Hospital of Cook County Chicago, Illinois
John Muir Medical Center-Walnut Creek Walnut Creek, California Site Public Contact - (clinicalresearch@johnmuirhealth.com)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kaiser Permanente - Kensington Medical Center Kensington, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente - Largo Medical Center Largo, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente Cancer Treatment Center South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Tysons Corner Medical Center McLean, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente- Marshall Medical Offices Redwood City, California
Kaiser Permanente-Burke Medical Center Burke, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Gaithersburg Medical Center Gaithersburg, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Stockton Stockton, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Woodlawn Medical Center Baltimore, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kuakini Medical Center Honolulu, Hawaii
Lahey Hospital and Medical Center Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Medical Center-Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lexington Medical Center West Columbia, South Carolina Site Public Contact - (research@lexhhealth.org)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Lyndon Baines Johnson General Hospital Houston, Texas
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marshall Cancer Center Cameron Park, California Site Public Contact - (cancerservices@marshallmedical.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin
Mayo Clinic Health Systems-Mankato Mankato, Minnesota
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
Mease Countryside Hospital Safety Harbor, Florida Site Public Contact - (research.cto@baycare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital Chattanooga, Tennessee Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
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Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Ankush Ratwani, MD - ankush.ratwani@vumc.org

NCT04996173
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Inclusion Criteria:

• Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis.
• Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation.
• Able to provide informed consent
• Age \> 18
Exclusion Criteria:

• Inability to provide informed consent.
• Pregnancy
• Known or suspected malignant central airway stenosis
• Patient has already been enrolled in this study.
• Study subject has any disease or condition that interferes with safe completion of the study including:
• Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
• Recent pneumothorax in the previous 12 months
• Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \< 30% predicted) and/or severe persistent asthma.
• Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians.
• Prior complications with SCT
• Contraindication to rigid bronchoscopy
• Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging.
• Greater then 1 BCAS intervention within 6 months before enrollment
DEVICE: Spray cryotherapy, DEVICE: Ballon Dilation, DEVICE: Radial Incision
Pulmonary Disease
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Study Locations

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Location Contacts
University of Mississippi Medical Center Jackson, Mississippi Stacy Porter - (sporter6@umc.edu)
Vanderbilt University Medical Center Nashville, Tennessee Brianna Swanner - (briana.swanner@vumc.org)
Virginia Commonwealth University Richmond, Virginia Ramsha Hamid - (ramsha.hamid@vcuhealth.org)

Advancing Water Security: A Community Participatory School-Based Hydration Intervention

Sarah Farthing, MS - sarah.malone@vcuhealth.org

Melanie Bean
NCT06714929
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Inclusion Criteria:
* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible * BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g) * Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district. * Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Exclusion Criteria:
* Lunchroom observations: None. * BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration * Student surveys: None. * Staff surveys: None.
BEHAVIORAL: Hydration
Dental Caries, Obesity Prevention
hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
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Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, PhD - (melanie.bean@vcuhealth.org)

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (REBIRTH)

Dennis McNamara, MD - mcnamaradm@upmc.edu

NCT05180773
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Inclusion Criteria:

• Presentation with a new diagnosis of peripartum cardiomyopathy
• Post-delivery and within the first 5 months post-partum.
• Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
• Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
• Age \> or = 18.
Exclusion Criteria:

• Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF \> 0.55 prior to or in early pregnancy)
• Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF.
• Postpartum women currently breastfeeding and planning to continue.
• Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
• Previous cardiac transplant
• Current durable LVAD support
• Currently requiring support with extracorporeal membrane oxygenation (ECMO)
• Current history of alcohol or drug abuse
• Chemotherapy or chest radiation within 5 years of enrollment
• Evidence of ongoing bacterial septicemia
• Medical, social or psychiatric condition which limit the ability to comply with follow-up.
DRUG: Bromocriptine, DRUG: Placebo, DRUG: Guideline Directed Medical Therapy for Heart Failure (GDMT), DRUG: Rivaroxaban, DRUG: Second Placebo
Peripartum Cardiomyopathy, Postpartum
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Study Locations

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Location Contacts
Albert Einstein College of Medicine/ Montefiore Medical Center The Bronx, New York Vanya Prasad - (vprasad@montefiore.org)
Ascension St. Vincent Heart Center Indianapolis, Indiana Anne Renick - (anne.renick@ascension.org) Regina Margiotti - (RAMARGIO@ascension.org)
Atrium Health Sanger Heart and Vascular Institute Charlotte, North Carolina Zaida Roman - (Zaida.roman@atriumhealth.org)
Baylor College of Medicine Houston, Texas Sandra Pena - (sandra.pena@bcm.edu)
Brigham and Women's Hospital Boston, Massachusetts Audrey Yun - (ayun1@bwh.harvard.edu) Mariam Markabani - (mmarkabani@bwh.harvard.edu)
Cedars-Sinai Medical Center Los Angeles, California Odette Chida Ibarra - (odette.chidaibarra@cshs.org)
Cleveland Clinic Cleveland, Ohio Barbara Gus - (gusb@ccf.org)
Columbia University Irving Medical Center New York, New York Barbara Alvarez - (bsa2133@cumc.columbia.edu)
Emory University Atlanta, Georgia Eisha Udeshi - (eudeshi@emory.edu) Nino Kavtaradze - (nkavtar@emory.edu)
Hartford Hospital Hartford, Connecticut Khadija El Aoudi - (Khadija.ElAoudi@hhchealth.org)
Henry Ford Health System Detroit, Michigan Jodi Carter - (jcarte23@hfhs.org)
Indiana University/Indiana University Health Indianapolis, Indiana Srdjan Kurbalija - (skurbalija@iuhealth.org)
Inova Healthcare Services Fairfax, Virginia Joanne Wotring - (joanne.wotring@inova.org)
Intermountain Medical Center Murray, Utah Morgan McClure - (morgan.mcclure@imail.org)
Johns Hopkins University Baltimore, Maryland Yavette Goldsborough - (ygoldsb1@jhmi.edu)
Karen L Florio, MD Columbia, Missouri Akira Clemons - (amcg5z@umsystem.edu)
Keck School of Medicine of USC Los Angeles, California Jorge Caro - (jorge.caro@med.usc.edu)
Lehigh Valley Health Network Allentown, Pennsylvania
Louisiana State University Shreveport, Louisiana Monicah Jepkemboi - (monicah.jepkemboi@lsuhs.edu)
Massachusetts General Hospital Boston, Massachusetts Monica Duan - (mduan2@mgb.org)
Mayo Clinic, Florida Jacksonville, Florida Jena Hayes - (hayes.jena@mayo.edu)
Mayo Clinic, Rochester Rochester, Minnesota Molly Dolan - (Dolan.Molly@mayo.edu) Brittni Ferdinand - (Ferdinand.brittni@mayo.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Amy Blair - (ablair@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Virginia Theodorof - (theodoro@musc.edu) Olivia Washington - (washoliv@musc.edu)
Minneapolis Heart Institute Foundation Minneapolis, Minnesota Sarah Schwager - (Sarah.Schwager@allina.com) Gretchen Benson - (GBenson@mhif.org)
Mount Sinai Hospital New York, New York Lovelyne Julien - (lovelyn.julien@mountsinai.org) Tiffany Soto - (tiffany.soto@mssm.edu)
NYU Langone Health New York, New York Lucia Muzzarelli - (Lucia.Muzzarelli@nyulangone.org)
Northwestern University Chicago, Illinois Jessica Patalino - (jessica.patalino@nm.org)
Oklahoma University Health Science Center Oklahoma City, Oklahoma Natalie Feland - (natalie-feland@ouhsc.edu)
Old Dominion University Norfolk, Virginia Kristin Ayers - (ayerskl@evms.edu)
Penn State Hershey Medical Center Hershey, Pennsylvania Katie Loffredo - (kloffredo@pennstatehealth.psu.edu) Veronica Bausher - (vbausher@pennstatehealth.psu.edu)
Rhode Island Hospital Providence, Rhode Island Kelly Franchetti, RN - (kfranchetti@lifespan.org)
Saint Luke's Hospital of Kansas City Kansas City, Missouri Rosann Gans, RN - (rgans@saint-lukes.org)
Stanford University Stanford, California Tamara Bazouzi - (bazouzit@stanford.edu)
Stern Cardiovascular Foundation, Inc Germantown, Tennessee Denise Peeler - (denise.peeler@sterncardio.com) Kari Fondren - (kari.fondren@sterncardio.com)
Stony Brook Medicine Stony Brook, New York Uzma Usmani - (Uzma.Usmani@stonybrookmedicine.edu)
Temple Heart and Vascular Institute Philadelphia, Pennsylvania Jennie Wong - (jennie.wong@tuhs.temple.edu)
UT Southern Medical Center Dallas, Texas
University Hospitals, Cleveland Medical Center Cleveland, Ohio Emily Mullenax - (Emily.Mullenax@UHhospitals.org)
University of Alabama Birmingham Birmingham, Alabama LaTangellia Walker - (latangelliadwalker@uabmc.edu) Nancy Saxon - (nbsaxon@uabmc.edu)
University of Arizona Sarver Heart Center Tucson, Arizona Lizzette Cruz - (marquez@shc.arizona.edu)
University of California Irvine Health Orange, California Linh Huỳnh, MPH - (plhuynh@hs.uci.edu)
University of California San Diego La Jolla, California Rachel Han - (rah015@health.ucsd.edu)
University of Colorado Anschutz Medical Campus Aurora, Colorado Jamie Demmitt, BA - (jamie.demmitt@cuanschutz.edu)
University of Florida Gainesville, Florida David Solares - (David.Solares@medicine.ufl.edu) Vanessa Holway Scheuble - (Vanessa.Scheuble@medicine.ufl.edu)
University of Illinois Health Heart Center Chicago, Illinois Muriel Chen - (yining@uic.edu)
University of Iowa Hospitals and Clinic Iowa City, Iowa Cynthia Larew - (cynthia-larew@uiowa.edu) Page Scovel - (page-scovel@uiowa.edu)
University of Kentucky, Gill Heart & Vascular Institute Lexington, Kentucky Jennifer Isaacs - (Jennifer.isaacs@uky.edu) Travis Sexton - (trsext2@uky.edu)
University of Maryland Medical Center, Baltimore Baltimore, Maryland Caitlin Hearn - (chearn@som.umaryland.edu)
University of Michigan Ann Arbor, Michigan Kavita Shah - (skavita@med.umich.edu)
University of Minnesota Minneapolis, Minnesota Melanie Farinella - (crawl027@umn.edu)
University of Pennsylvania Philadelphia, Pennsylvania Alavi Hossain - (Alavi.Hossain@Pennmedicine.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Dennis McNamara, MD - (mcnamaradm@upmc.edu) Donna Simpson, CRNP, MPH - (simpsondm@upmc.edu)
University of Rochester Rochester, New York Lori Caufield, RN BSN CCRC - (lori_caufield@urmc.rochester.edu)
University of South Florida Tampa, Florida Amanda McNamara - (alett1@usf.edu) Jacky He - (jackyhe@usf.edu)
University of Texas Health San Antonio San Antonio, Texas
University of Vermont Medical Center Burlington, Vermont Meghan Sesera, RN - (meghan.sesera@uvmhealth.org) Michaelanne Rowen - (Michaelanne.Rowen@uvmhealth.org)
University of Virginia Charlottesville, Virginia Melanie Dean - (DMD4PD@uvahealth.org) Caroline Flournoy - (clf4w@uvahealth.org)
University of Washington Medical Center Seattle, Washington Adele Stefanowicz - (amstef99@cardiology.washington.edu)
University of Wisconsin Madison Madison, Wisconsin Holly Hage - (hhage@wisc.edu) Karen Olson - (kjolson@medicine.wisc.edu)
Vanderbilt Nashville, Tennessee Olivia Patridge - (olivia.h.patridge@vumc.org)
Virginia Commonwealth University Richmond, Virginia Melissa Sears - (melissa.sears@vcuhealth.org)
Washington University School of Medicine St Louis, Missouri Annie Dirks - (aplatts@wustl.edu) Lesley Alexander - (alesley@wustl.edu)
Yale University New Haven, Connecticut Cinthia S De Freitas - (cinthia.defreitas@yale.edu)

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (FORTE)

Director, Department of Regulatory Affairs - langerj@nrgoncology.org

NCT05080673
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Inclusion Criteria:
* The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish.
Exclusion Criteria:
* • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size. * Traditional serrated adenomas found on the qualifying colonoscopy. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy. * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization. * Incomplete qualifying colonoscopy (e.g., cecum not visualized). * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.) * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.) * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]). * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis). * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.
PROCEDURE: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Mercy Hospital Council Bluffs, Iowa
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Alta Bates Summit Medical Center - Summit Campus Oakland, California
Altru Cancer Center Grand Forks, North Dakota
Ann M Wierman MD LTD Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Armes Family Cancer Center Findlay, Ohio
Ascension All Saints Hospital Racine, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital Chilton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Saint Francis Hospital Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BASS Medical Group - Lennon Walnut Creek, California Site Public Contact - (brenna.lindsey@bassmedicalgroup.com)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Tumor Institute Oakland, California
Bay Pines VA Healthcare System Bay Pines, Florida Site Public Contact - (vhabayresearch@va.gov)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming Site Public Contact - (research@billingsclinic.org)
Blanchard Valley Hospital Findlay, Ohio
Boston Veteran's Affairs Medical Center Jamaica Plain, Massachusetts Site Public Contact - (ctsucontact@westat.com)
Boulder Community Foothills Hospital Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Health Saint Francis Grand Island, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
CTCA at Western Regional Medical Center Goodyear, Arizona
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Camden Clark Medical Center Parkersburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Center-Metro Medical Center Bayamon Bayamón,
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois
Carle Physician Group-Effingham Effingham, Illinois
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois
Carle at The Riverfront Danville, Illinois
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (Roster@nrgoncology.org)
Colorado Blood Cancer Institute Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
CommonSpirit Cancer Center Mercy Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Dayton Physicians LLC-Wayne Greenville, Ohio
Doctors Cancer Center Manatí,
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota
Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota
Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota
Essentia Health - Saint Joseph's Staples Clinic Staples, Minnesota
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
George Washington University Medical Center Washington D.C., District of Columbia
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa
HIMA San Pablo Oncologic Hospital Caguas,
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (Roster@nrgoncology.org)
Highline Medical Center-Main Campus Burien, Washington
Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
Idaho Urologic Institute-Meridian Meridian, Idaho
Indu and Raj Soin Medical Center Beavercreek, Ohio
Instituto Oncologia Moderna Ponce Ponce,
Jefferson Healthcare Port Townsend, Washington
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kaiser Permanente - Kensington Medical Center Kensington, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente - Largo Medical Center Largo, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Tysons Corner Medical Center McLean, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Burke Medical Center Burke, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Franklin Denver, Colorado Site Public Contact - (kristi.m.bronkan@kp.org)
Kaiser Permanente-Gaithersburg Medical Center Gaithersburg, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Lone Tree Lone Tree, Colorado Site Public Contact - (kristi.m.bronkan@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
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Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population (ACE)

Lavin Entwisle - lentwisle@cochlear.com

NCT06293482
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Inclusion Criteria:
* Individuals 18 or older at the time of consent * Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as \<50% correct on a word recognition test * Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of \>30 dB HL * Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. * Willing and able to provide written informed consent.
Exclusion Criteria:
* Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies) * Absence of cochlea development or a cochlear nerve * Presence of active middle ear infection in the ear to be implanted * Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted * Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation. * Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation. * Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation. * Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator. * Additional disabilities that may affect the participant's participation of safety during the clinical investigation. * Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Employees of Cochlear. * Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
DEVICE: Cochlear™ Nucleus® System
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Cochlear implant, Sensorineural hearing loss, Safety, Efficacy
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Study Locations

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Location Contacts
Barrow Neurological Institute Phoenix, Arizona Shawn Stevens - (shawn.stevens@commonspirit.org)
Centre for Neurosciences Tucson, Arizona Gwendolyn Grabiec - (GGrabiec@neurotucson.com)
Cleveland Clinic Cleveland, Ohio Sarah Sydlowski - (sydlows@ccf.org)
Indiana University Indianapolis, Indiana Rick Nelson, MD - (ricnelso@iupui.edu)
Midwest Ear Institute Kansas City, Missouri Sarah Zlomke - (sking@saint-lukes.org)
New York University New York, New York William Shapiro - (william.shapiro@nyulangone.org)
Pacific Neuroscience Institute Santa Monica, California Courtney Voelker, MD - (Courtney.Voelker@providence.org)
University of Miami Miami, Florida Meredith Holcomb - (meredith.holcomb@med.miami.edu)
University of Pennsylvania Hospitals Philadelphia, Pennsylvania Tiffany Hwa - (tiffany.hwa@pennmedicine.upenn.edu)
Virginia Commonwealth University Richmond, Virginia
Virginia Mason Seattle, Washington

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Clinical Trials Administrator - clinicaltrials@regeneron.com

NCT03564340
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Key
Inclusion Criteria:

• Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
• serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
• has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
• documented relapse or progression on or after the most recent line of therapy
• no standard therapy options likely to convey clinical benefit
• Adequate organ and bone marrow function as defined in the protocol
• Life expectancy of at least 3 months
• Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
• Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
• MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
• 1-4 prior lines of systemic therapy, as described in the protocol Key
Exclusion Criteria:

• Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
• Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
• Prior treatment with a MUC16 - targeted therapy
• Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
• History and/or current cardiovascular disease, as defined in the protocol
• Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen Note: Other protocol-defined Inclusion/Exclusion Criteria apply
DRUG: Ubamatamab, DRUG: Cemiplimab, DRUG: Sarilumab, DRUG: Tocilizumab
Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Recurrent Endometrial Cancer, Endometrial Cancer, Low-grade Serous Ovarian Cancer
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Asan Medical Center, Univ. of Ulsan Seoul,
Centre Antoine Lacassagne Nice,
Centre Francois Baclesse (CFB) Caen, Normandy
Centre Georges Francois Leclerc Dijon,
Clinica Universidad Navarra (CUN) Madrid Madrid,
Clinica Universidad de Navarra Madrid,
Columbia University Medical Center New York, New York
Dana Farber / Harvard Cancer Center Boston, Massachusetts
Erasmus MC Rotterdam,
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma,
Fundacion Jimenez Diaz Madrid,
Grand Hopital de Charleroi Charleroi, Hainaut
Guys Hospital London,
Hopital Lyon Sud Lyon, Pierre-Benite
Hospital Clinico Universitatio Santiago de Compostela Santiago de Compostela,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario San Carlos Madrid,
Imperial College Healthcare NHS Trust London, Greater London
Institut Bergonie Bordeaux,
Institut Catala d'Oncologia Barcelona,
Institut Catala d'Oncologia Barcelona,
Institut Catala dOncologia Badalona Badalona,
Institut Gustave Roussy Villejuif,
Instituto Nazionale Tumori- Fondazione Pascale Naples,
Istituto Europeo Di Oncologia Milan,
Korea University Guro Hospital Seoul,
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Rochester Rochester, Minnesota
Memorial Sloan Kettering Cancer Center New York, New York
Peter MacCallum Cancer Center Melbourne, Victoria
Prince of Wales Hospital Grimsby,
Radboudumc Nijmegen, Gelderland
Rambam Health Care Campus Haifa,
Roswell Park Cancer Institute Buffalo, New York
Royal Marsden Hospital - Sutton Sutton, Surrey
Samsung Medical Center Seoul,
Sarah Cannon Research Institute London, England
Seoul National University Hospital Seoul,
Sharet Institute of Oncology Jerusalem,
Sheba Medical Center Ramat Gan,
Stephenson Cancer Center Oklahoma City, Oklahoma
The Christie NHS Foundation Trust Manchester,
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center Hilliard, Ohio
The Royal Marsden NHS Foundation Trust London,
UZLeuven Leuven, Vlaams Brabant
Universitair Ziekenhuis Antwerpen Edegem,
University College London Hospitals London,
University Medical Center Groningen Groningen,
University of Alabama_6th Ave Birmingham, Alabama
University of Oxford Oxford, Oxfordshire
Virginia Commonwealth University Richmond, Virginia
Yonsei University Health System Seoul,

FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study (FRESH)

Steven Lauder - steven.lauder@interceptpharma.com

NCT05639543
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Inclusion Criteria:

• Males or females aged 18 to 65 years (inclusive)
• Clinical diagnosis of sAH based on all the following:
• History of ongoing excess alcohol (\>60 g/day \[male\] or \>40 g/day \[female\]) use for ≥6 months, with \<60 days of abstinence prior to the onset of jaundice
• Serum total bilirubin \>3.0 mg/dL
• Aspartate aminotransferase (AST) ≥50 U/L
• AST/Aspartate aminotransferase (ALT) ratio ≥1.5
• Onset of jaundice within prior 8 weeks
• Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
• Cohort 5 and Cohort 6: mDF ≥32
• Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
• Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows: * Surgical sterilization (bilateral tubal occlusion, etc.) * Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system \[IUS\]) * Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation: * Oral * Intravaginal * Transdermal * Progesterone-only hormonal contraception associated with inhibition of ovulation: * Oral * Injectable * Implantable * Sexual abstinence: When in line with the preferred and usual lifestyle of the participant, is defined as avoiding all types of activity that could result in conception (pregnancy) from the initiation of Screening and until at least 90 days after the last dose of investigational product
• Male participants who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use 1 other approved method of highly effective contraception from the initiation of Screening and until at least 90 days after the dose of investigational product as listed in Inclusion Criteria #3.
• Male participants must refrain from sperm donation from the initiation of Screening and until at least 90 days after the last dose of investigational product
• Must provide written informed consent and agree to comply with the study protocol. In participants with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).
• Participants must agree to participate in an alcohol use disorder program during the study period, as recommended by the local institution's addiction medicine specialists, including post-hospitalization
Exclusion Criteria:

• Participants taking products containing obeticholic acid in the 30 days prior to randomization
• Participants taking \>2 doses of systemic corticosteroids within 30 days prior to randomization.
• Participants who have been inpatient at a referral hospital for \>7 days prior to transfer.
• Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
• Abstinence from alcohol consumption for \>2 months before Day 1.
• AST or ALT \>400 U/L.
• Cohort 1 through Cohort 4: mDF \<32 or \>70.
• Cohort 5 and Cohort 6: mDF \<32
• Cohort 1 through Cohort 4: MELD score \<18 or \>25.
• Cohort 5 and Cohort 6: MELD \<21 or \>30
• Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen \[HBsAg\] positive), chronic hepatitis C virus (HCV) RNA positive, drug-induced liver injury (DILI), biliary obstruction, and autoimmune liver disease.
• Current or previous history of hepatocellular carcinoma (HCC)
• History of liver transplantation or currently listed for liver transplant
• Untreated infection (e.g., has not initiated appropriate medical treatment for infection)
• Known positivity for human immunodeficiency virus infection
• Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding that was associated with shock or required transfusion of more than 3 units of blood within 7 days of Screening.
• Kidney injury defined as a serum creatinine \>133 μmol/L (\>1.5 mg/dL) or the requirement for renal replacement therapy whether prior to or after study screening.
• Portal vein thrombosis
• Acute pancreatitis or acute gallbladder disease (e.g., cholecystitis)
• Severe, on-going associated disease (e.g., cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease)
• Malignancy within the 2 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer). Participants under evaluation for possible malignancy are not eligible.
• Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cocaine, and opiates) except tetrahydrocannabinol or in the setting of documented prescription medications (e.g., opiates, benzodiazepines, amphetamines, barbiturates), which also include medications prescribed as part of in-patient management. Participants being treated for alcohol withdrawal may be exempt for this reason, verify with Medical Monitor.
• Participated in a clinical research study and received any active investigational product being evaluated for the treatment of sAH within 3 months before Day 1
• Participation in a study of another investigational medicine or device within 30 days before Screening
• Any other condition or clinical laboratory result that, in the opinion of the Investigator, might confound the results, or would impede compliance or hinder completion of the study
• Participants treated in the Dose Escalation Phase (Cohort 1 through Cohort 4) are not eligible for enrollment into an Extension Cohort (Cohort 5 and Cohort 6), and participants treated in Cohort 5 are not eligible for enrollment into Cohort 6.
DRUG: INT-787, DRUG: Placebo
Alcohol Associated Hepatitis
Severe Alcohol associated Hepatitis (sAH), Alcoholic Hepatitis (AH), Hepatitis, Alcoholic
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Baylor College of Medicine Houston, Texas Megha Bhongade - (megha.bhongade@bcm.edu)
Beth Israel Deaconess Medical Center Boston, Massachusetts
CHU Angers Angers,
Cambridge University NHS Foundation Trust Cambridge,
Clinical Translational Research Site Miami, Florida
Columbia University Medical Center/New York Presbyterian Hospital New York, New York
Henry Ford Health System Detroit, Michigan
Hopital Beaujon Clichy,
Hopital Claude Huriez Lille,
Hopital Rangueil Toulouse,
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Hôpital Pitié Salpêtrière Paris,
Imperial College Healthcare NHS Trust London, Greater London
King's College Hospital London, Andrew Ayers - (Andrew.ayers@nhs.net)
Mayo Clinic Jacksonville, Florida
Medical University of South Carolina Charleston, South Carolina
Mercy Medical Center Springfield, Massachusetts
Northwell Health Center for Liver Disease and Transplantation Manhasset, New York
Parkland Health and Hospital System Dallas, Texas
Royal Free Hospital London,
Rush University Medical Center Chicago, Illinois
Rutgers-New Jersey Medical School Newark, New Jersey
Stanford Healthcare Stanford, California
Tampa General Medical Group Tampa, Florida
The Liver Institute at Methodist Dallas Medical Center Dallas, Texas
UMass Memorial Medical Center Worcester, Massachusetts Anne Foley - (anne.foley@umassmemorial.org)
University Hospitals Plymouth NHS Trust Plymouth,
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Hospital Salt Lake City, Utah
VCU Health Clinical Research Services Unit Richmond, Virginia
Vanderbilt Digestive Disease Center Nashville, Tennessee

Psychobiological Responses Following Exercise and Brain Stimulation

Edmund Acevedo - eoacevedo@vcu.edu

NCT06874595
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Inclusion Criteria:
* Healthy adults * aged 18 to 50 * consent and complete a Physical Activity Readiness Questionnaire (PAR-Q) * be free from any neurological or psychiatric disorder * not be taking any medication that could affect the central nervous system * not have any contraindication for HD-tDCS (i.e. not having metal implanted in the head, pacemaker, medical bumps, seizures, lesions on the scalp or head ) or for bioelectrical impedance (i.e., electronic medical implant, such as a pacemaker or implantable cardioverter defibrillator, and limb amputation) * not be regular users of tobacco products (cigarettes, cigars, chewing tobacco) * not consume an average of more than ten alcoholic beverages per week
Exclusion Criteria:
* Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity will be excluded from participating in this study * women who are pregnant will be exclude from this study
OTHER: Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), OTHER: Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS), OTHER: No exercise followed by HD-tDCS (no exercise + HD-tDCS)., OTHER: State Anxiety Inventory, OTHER: Visual Analog Scale for Anxiety
Psychological
Exercise and Brain Stimulation
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Virginia Commonwealth University Richmond, Virginia Edmund Acevedo, PhD - (eoacevedo@vcu.edu)

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Joseph T Hull, PhD - jhull@supernus.com

NCT04781140
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Inclusion Criteria:

• Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.
• Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.
• Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.
• Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study).
• Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.
• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
Exclusion Criteria:

• Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.
• Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.
• Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).
• Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).
• Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).
DRUG: 100mg SPN-812, DRUG: Placebo
Attention-Deficit/Hyperactivity Disorder
ADHD
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AIM Trials Plano, Texas - (info@aimtrials.com)
APG Research LLC Orlando, Florida - (Mollie@apghealth.com)
Accel Research Sites-LKD CRU Lakeland, Florida - (recruiting@accelclinical.com)
Advanced Discovery Research LLC Atlanta, Georgia - (contact@advdiscovery.com)
Advanced Research Center (ARC), Inc. Anaheim, California - (contact@arctrials.com)
Alliance Research Long Beach, California - (Research@asclepes.com)
Avantis Clinical Research LLC Miami, Florida - (info@avantisclinicalresearch.com)
Boston Children's Hospital Boston, Massachusetts - (leslie.smitley@childrens.harvard.edu) - (ResAdmin@childrens.harvard.edu)
CenExcel iResearch, LLC Decatur, Georgia
CenExel iResearch, LLC. Savannah, Georgia
Cincinnati Children's Hospital and Medical Center Cincinnati, Ohio - (ADHDResearch@cchmc.org)
CincyScience West Chester, Ohio - (research@cincyscience.com)
Clinical Integrative Research Center of Atlanta Atlanta, Georgia
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical Research Partners, LLC Petersburg, Virginia
Clinical Research of Southern Nevada, LLC. Las Vegas, Nevada - (kluna.cpbm@gmail.com)
Coastal Carolina Research Center North Charleston, South Carolina - (CCRC@CoastalCarolinaResearch.com)
Coastal Pediatric Research Summerville, South Carolina - (info.research@cpakids.com)
Cyn3rgy Research Gresham, Oregon - (support@cyn3rgy.com)
D&H Tamarac Research Center Tamarac, Florida - (info@dhnrc.com)
DelRicht Research Baton Rouge, Louisiana - (info@delricht.com)
DelRicht Research (Touro Medical Center) New Orleans, Louisiana - (info@delricht.com)
Duke University Durham, North Carolina
Family Psych of The Woodlands The Woodlands, Texas - (info@woodlandspsych.com)
Hope Research Network, LLC. Miami, Florida - (info@hoperesearchnetwork.com)
Houston Clinical Trials, LLC. Bellaire, Texas
IMMUNOe Research Centers Centennial, Colorado - (verosinfo@veroshealth.com)
Icahn School of Medicine at Mount Sinai New York, New York
Javara Dallas, Texas
Jersey Shore University Medical Center Neptune City, New Jersey - (andrew.layman@hmhn.org)
Kennedy Krieger Institute Baltimore, Maryland
Kentucky Pediatric/Adult Research Bardstown, Kentucky - (kpar@kpar.us)
Luna Research Center Coral Gables, Florida
Med Clinical Research Irvington, New Jersey - (info@medclinicalresearch.com)
Medical Research Group of Central Florida Orange City, Florida
National Institute of Clinical Research (NICR) Garden Grove, California
Neurobehavioral Medicine Group Bloomfield Hills, Michigan - (info@neurobmg.com)
Penn State Health Milton S. Hershey Medical Center-Investigational Drug Service Pharmacy Hershey, Pennsylvania - (rmyers12@pennstatehealth.psu.edu)
Precise Research Centers Flowood, Mississippi
Preferred Research Partners - NWA, LLC Fayetteville, Arkansas
Preferred Research Partners, Inc. Little Rock, Arkansas - (info@preferredresearchpartners.com)
Qualmedica Research, LLC. Owensboro, Kentucky
Qualmedica Research, LLC. Owensboro, Kentucky
Sarkis Clinical Trials Gainesville, Florida
Sun Valley Research Center Imperial, California - (svrcinfo@sunvalleyb.com)
The Center for Clinical Trials, Inc. Saraland, Alabama - (info@thecenterforclinicaltrials.com)
Virginia Commonwealth University, Virginia Treatment Center for Children Richmond, Virginia

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Novartis Pharmaceuticals - novartis.email@novartis.com

NCT05268289
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Inclusion Criteria:
Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS. eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study. First presentation or flare of lupus nephritis.
Exclusion Criteria:
Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening. Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy. Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease. Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment) Other protocol-defined inclusion/exclusion criteria may apply
DRUG: Iptacopan (part 1), DRUG: Iptacopan (part 2), DRUG: Placebo + standard of care, DRUG: Iptacopan + placebo
Lupus Nephritis
LNP023, Iptacopan, Lupus Nephritis, proteinuria, Urine Protein-to-Creatinine Ratio, complete renal response, estimated glomerular filtration rate, renal flares, Systemic Lupus Erythematosus
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AKDHC Medical Research ServicesLLC Phoenix, Arizona
Allegheny Health Network Pittsburgh, Pennsylvania
Brigham and Womens Hosp Harvard Med School Boston, Massachusetts Katherine Curtis - (kcurtis2@bwh.harvard.edu)
Cleveland Clinic Foundation Cleveland, Ohio
Dallas Nephrology Associates Dallas, Texas Esmeralda Martinez - (Martinezes@dneph.com)
FDI Clinical Research San Juan,
Florida Kidney Physicians Riverview, Florida
Florida Kidney Physicians Riverview, Florida
Johns Hopkins Hospital Baltimore, Maryland
Kaiser Permanente Fontana Fontana, California Kimberly Cortez - (kimberly.x.cortez@kp.org)
Loma Linda University Loma Linda, California Brenda Delgado - (bdelgado@llu.edu)
Mayo Clinic Jacksonville Jacksonville, Florida Trinity Hooks - (Hooks.Trinity@mayo.edu)
Mayo Clinic Rochester Rochester, Minnesota
Nep Assoc of Northern Illinois Hinsdale, Illinois
Nephrology Associates Of Central FL Orlando, Florida
Novartis Investigative Site London,
Novartis Investigative Site London,
Novartis Investigative Site London,
Novartis Investigative Site London,
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Ochsner Health System New Orleans, Louisiana
Olive View UCLA Medical Center Sylmar, California
Prolato Clinical Research Center Houston, Texas Debbie Era - (dera@prolato.org)
Ronald Reagan UCLA Medical Center Los Angeles, California
Royal Research Corp Hollywood, Florida
Stony Brook Internists PC East Setauket, New York
Temple University Philadelphia, Pennsylvania Zoe Pfeffer - (Zoe.pfeffer@tuhs.temple.edu)
Univ Calif Irvine Irvine, California
University of Colorado Denver Aurora, Colorado
University of Nebraska Medical Center Omaha, Nebraska
Virginia Commonwealth University Richmond, Virginia Olufunso Fasoyiro - (Olufunso.Fasoyiro1@vcuhealth.org)
Wichita Community Clcl Onco Program Wichita, Kansas Joanna Haddad - (jhaddad@wngpa.com)

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART) (AID-HEART)

Benjamin VanTassell - bvantassell@vcu.edu

NCT06062966
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Inclusion Criteria:
* Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days) * Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality (within 12 months) * Stable dose of inotrope treatment without a recent hospitalization within the previous month * Age ≥21 years and willing/able to provide written informed consent * The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol). * Screening plasma C-reactive protein levels \>2 mg/L
Exclusion Criteria:
* Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration that would interfere with the execution, interpretation, or completion of the study * Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries * Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months * Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs) * Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) * Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA * Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer * Stage V kidney disease or on renal-replacement therapy * Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients) * Pregnancy or breastfeeding * Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing * Hypersensitivity to anakinra or to E. coli derived products
DRUG: Anakinra
Heart Failure
Inotrope sensitivity, IL-1 Blockade, Subcutaneous (SC), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV, 6 Minute Walk Test (6MWT)
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Virginia Commonwealth University Richmond, Virginia Azita Talasazah - (talasazah@vcu.edu) Benjamin Van Tassell - (bvantassell@vcu.edu)

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack (ARTEMIS)

Novo Nordisk - clinicaltrials@novonordisk.com

NCT06118281
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Key inclusion: * Age 18 years or above at the time of signing the informed consent. * Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities. * ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion. b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads. OR * Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit. * Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 hours of hospitalisation (time 0) for NSTEMI. * Presence of at least one of the following criteria confirmed based on the participant's medical records and/or medical history interview: a) Any prior MI. b) Prior coronary revascularisation. c) Diabetes mellitus treated with ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2). e) Prior ischaemic stroke. f) Known carotid disease or peripheral artery disease in the lower extremities. g) Multivessel coronary artery disease (current/prior). h) For STEMI patients only: anterior MI at index acute myocardial infarction (AMI) Key exclusion: * Use of fibrinolytic therapy for treatment of the current AMI. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV. * Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg)). * Severe kidney impairment defined as any of the following: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) Chronic haemodialysis or peritoneal dialysis. * Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN). * Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation). b) Previously known or current ascites (clinical eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) Known hepatic cirrhosis. * Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery (CABG)), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged)percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed. * Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. * Known (acute or chronic) hepatitis B or hepatitis C. * History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation. b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2).
DRUG: Ziltivekimab, DRUG: Placebo
Cardiovascular Risk, Acute Myocardial Infarction (AMI)
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Location Contacts
"AHEPA" University General Hospital of Thessaloniki Thessaloniki,
"AHEPA" University General Hospital of Thessaloniki Thessaloniki,
"Hygeia" General Hospital of Athens Athens,
"MHAT - Pazardzhik" Pazardzhik,
"Sotiria" Thoracic Diseases Hospital of Athens Athens,
"UMHAT "Aleksandrovska" EAD, Cardiology clinic Sofia,
"UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology Sofia,
"UMHAT-Burgas" Burgas,
"UMHATEM N.I. Pirogov" EAD Sofia,
'G. Gennimatas' General Hospital of Athens Athens,
'G. Gennimatas' General Hospital of Athens Athens,
'MHAT Hadzhi Dimitar' OOD Sliven,
'MHAT Sveta Karidad' EAD Plovdiv,
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ Lublin,
10 Wojskowy Szpital Kliniczny z Polikliniką - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Bydgoszczy Bydgoszcz,
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship
A.O.U Città della Salute e della Scienza di Torino Torino,
A.O.U Città della Salute e della Scienza di Torino Torino,
A.O.U. Ferrara, Sant'Anna Cona (Ferrara), Fe
AORN "Sant'Anna e San Sebastiano" Caserta, Ce
AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia Novara,
AOUI Verona Verona,
ASSOCIAÇÃO LAR SÃO FRANCISCO DE ASSIS NA PROVIDÊNCIA DE DEUS - Hospital Regional de Presidente Prudente Presidente Prudente, São Paulo
AUSL Romagna - Distretto Rimini - Ospedale Infermi Rimini,
Aakash Healthcare Super Speciality Hospital New Delhi,
Aalborg Universitetshospital Kardiologisk Afdeling Aalborg,
Aalborg Universitetshospital Kardiologisk Afdeling Aalborg,
Aarhus Universitetshospital, Hjertesygdomme Aarhus N,
Abbott Northwestern Hospital Minneapolis, Minnesota
Acibadem City Clinic UMHAT EOOD Sofia,
Acibadem City Clinic UMHAT Tokuda EAD Sofia,
Advanced Cardiovascular, LLC Alexander City, Alabama
Advanced Heart & Vein Center Thornton, Colorado
Advanced Heart Care LLC Bridgewater, New Jersey
Adventist Healthcare Shady Grove Medical Center Rockville, Maryland
Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar,
Ajou University Hospital Suwon, Gyeonggi-do
Akdeniz University Medical Faculty Antalya,
Alexandra General Hospital, Therapeutic Clinic Athens,
All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi
All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi
All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar, Odisha
All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur, Maharashtra
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
American Heart of Poland S.A. Zgierz,
Amper Kliniken AG - Helios Amper-Klinikum Dachau - Kardiologie Dachau,
Amphia Ziekenhuis Breda,
AnMed Health Clinical Research Anderson, South Carolina
Ankara Sehir Hastanesi Cardiology Ankara,
Ankara University Medical Faculty Ankara,
Antalya İl Sağlık Müdürlüğü Antalya EAH Muratpasa/ Antalya,
Ap-Hp-Hopital Bichat-Claude Bernard-1 Paris,
Ap-Hp-Hopital Europeen Georges Pompidou Paris,
Aphp-Hopital La Pitie Salpetriere-1 Paris,
Apollo Multispeciality Hospital, Kolkata Kolkata, West Bengal
Arcispedale S Maria Nuova Azienda ULSS-IRCCS Reggio Emilia,
Arkansas Cardiology Clinic Little Rock, Arkansas
Arneja Heart & Multispeciality Hospital Nagpur, Maharashtra
Asahi General Hospital_Cardiology Chiba,
Asan Medical Center Seoul,
Ascension Sacred Heart Pensacola, Florida
Ascension St. Mary's Research Institute - Michigan Southfield, Michigan
Asklepieion General Hospital Athens/Voula,
Asklepios Klinik Langen - Medizinische Klinik I Langen,
Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1 Marseille,
Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista Bragança Paulista, São Paulo
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital New Delhi, National Capital Territory of Delhi
Atlanta VAMC Decatur, Georgia
AtlantiCare Regional Medi Cnt Pomona, New Jersey
Augusta University Augusta, Georgia
Augusta University Augusta, Georgia
Aultman Hospital Canton, Ohio
Aurora St. Luke's Medi Ctr Milwaukee, Wisconsin
Austin Health Heidelberg, Victoria
Austin Heart Austin, Texas
Azienda Ospedaliera Santa Maria Degli Angeli Pordenone, PN
Azienda Ospedaliera Universitaria Careggi Florence, Tuscany
Azienda Ospedaliera Universitaria Federico II di Napoli Napoli,
Azienda Ospedaliera di Parma Parma,
Azienda Ospedaliera di Parma Parma,
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Napoli,
Azienda Ospedaliero - Universitaria Sant'Andrea Rome,
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara Novara,
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro, Cz
Azienda Ospedaliero-Universitaria SS Antonio e Biagio e Cesare Arrigo Alessandria,
Azienda Sanitaria Friuli Occidentale - Azienda Ospedaliera Santa Maria Degli Angeli - SC Cardiologia Pordenone Pordenone, PN
Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia Torino, To
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo, Lombardy
Azienda Unità Sanitaria Locale Di Piacenza - Cardiologia Piacenza,
B M Birla Heart Research Centre Kolkata, West Bengal
B M Birla Heart Research Centre Kolkata, West Bengal
BG Klinikum Unfallkrankenhaus Berlin GmbH - Klinik für Kardiologie Berlin,
Baptist Clin Res Institute Memphis, Tennessee
Baptist Heart Specialists Jacksonville, Florida
Baptist Hospital Cardiology Pensacola, Florida
Barts Heart Centre London,
Barts Heart Centre London,
Barwon Health (The Geelong Hospital) Geelong, Victoria
Batra Hospital and Medical Research Center New Delhi, National Capital Territory of Delhi
Baylor Scott & White Res Inst Plano, Texas
Beijing Anzhen Hospital, Capital Medical University Beijing, Beijing Municipality
Bellvitge Universitary Hospital Badalona,
Birmingham VA Medical Center Birmingham, Alabama
Blackpool Victoria Hospital Blackpool,
Bon Secours St. Mary's Hospital of Richmond, LLC Richmond, Virginia
Bravis Ziekenhuis Roosendaal,
Bremer Institut für Herz- und Kreislaufforschung (BIHKF) Bremen,
Bridgeport Hospital Bridgeport, Connecticut
Brigham & Women's Hospital Boston, Massachusetts
Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji Bursa,
Bursa Şehir Hastanesi- Kardiyoloji Bursa,
CHU de Quebec-Universite-Laval,HDQ Québec,
CHUM Centre de Recherch Hotel-Dieu Montreal, Quebec
CHUM Centre de Recherch Hotel-Dieu Montreal, Quebec
CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto, São Paulo
CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto, São Paulo
CISSS de Lanaudiere - Centre hospitalier De Lanaudiere Saint-Charles-Borromée, Quebec
CISSSL Hôsp Pierre-Le Gardeur Terrebonne, Quebec
CIUSS Hopit de Chicoutimi Chicoutimi, Quebec
CV Research of Knoxville Powell, Tennessee
Cairns Base Hospital Cairns, Queensland
Cangzhou Central Hospital Cangzhou Shi, Hebei
Canisius-Wilhelmina ziekenhuis Nijmegen,
Cardio. Consult. of S. GA Thomasville, Georgia
Cardiolg Assoc Rsch LLC_Tupelo Tupelo, Mississippi
Cardiology Associates of Fairfield County Stamford, Connecticut
Cardiology Associates_Asheville Asheville, North Carolina
Cardiología Hospital J. M. Ramos Mejia Buenos Aires,
Cardiovascular Associates of the Delaware Valley Vineland, New Jersey
Catharina Ziekenhuis Eindhoven Eindhoven,
Cellitinnen-Krankenhaus St. Vinzenz Köln - Kardiologie Cologne,
Central Arkansas Veteran's Healthcare System Little Rock, Arkansas
Central India Cardiology Hospital and Research Institute Nagpur, Maharashtra
Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau Chambray-lès-Tours,
Centre Hospitalier Saint Joseph Saint Luc Lyon,
Centre Hospitalier Sud Francilien Corbeil-Essonnes,
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1 Grenoble,
Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz Besançon,
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1 Pessac,
Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1 Caen,
Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon Lille,
Centre Hospitalier Universitaire de Nice-Hopital Pasteur Nice,
Centre Hospitalier Universitaire de Poitiers Poitiers,
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse,
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse,
Centre hosp affilié univ rég Trois-Rivières, Quebec
Centro Médico Nacional Siglo XXI Mexico City,
Centro Privado de Cardiología San Miguel de Tucuimán, Tucumán Province
Centro de Estudios Clinicos de Querétaro S.C. Querétaro,
Centro de Estudios Clinicos de Querétaro S.C. Querétaro,
Centro de Imagen y Tecnologia en Intervención Cardiovascular México, La Magdalena Contreras
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio San Miguel de Tucumán, Tucumán Province
Centro de Pesquisa Clínica do Hospital de Clínicas da Universidade Federal de Uberlândia Uberlândia, Minas Gerais
Centro de atención e investigación cardiovascular del Potosí San Luis Potosí City,
Cerrahpaşa Kardiyoloji Enstitüsü Istanbul,
Chambersburg Hospital Chambersburg, Pennsylvania
Charité - Campus Benjamin Franklin - Klinik für Kardiologie Berlin,
Chattanooga Heart Institute Chattanooga, Tennessee
Chattanooga Heart Institute Chattanooga, Tennessee
China-Japan Friendship Hospital Beijing,
China-Japan Friendship Hospital Beijing,
China-Japan Union Hospital of Jilin University Changchun, Jilin
China-Japan Union Hospital of Jilin University-Cardiology Changchun, Jilin
Chinese Academy of Medical Sciences Fuwai Hospital Beijing, Beijing Municipality
Chippenham Medical Center Richmond, Virginia
Chonnam National University Hospital Gwangju,
Chopda Medicare and Research Centre Pvt. Ltd. Nashik, Maharashtra
Christiana Care Health Services, Inc. Newark, Delaware
Christus Heart and Vascular Institute Tyler, Texas
Chru de Nancy - Hopital Brabois Vandœuvre-lès-Nancy,
Chungbuk National University Hospital Chungju,
Chungnam National University Hospital Daejeon,
Chungnam National University Sejong Hospital Sejong-si,
Cleveland Clinic_Cleveland Cleveland, Ohio
Clínica Privada Velez Sarsfield Córdoba,
Clínica Privada Velez Sarsfield Córdoba,
Complejo Hospitalario Universitario A Coruna A Coruña,
Concord Repatriation General Hospital - Cardiology Department Concord, New South Wales
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk,
Corewell Health Grand Rapids, Michigan
Dallas VA Medical Center Dallas, Texas
Danbury Hospital - Cardiology Department Danbury, Connecticut
Dartmouth-Hitchcock Med Ctr Lebanon, New Hampshire
Dayanand Medical College & Hospital Ludhiana, Punjab
Deenanath Mangeshkar Hospital & Research Centre Pune,
Deenanath Mangeshkar Hospital & Research Centre Pune,
Denver Health Medical Center Denver, Colorado
Derriford Hospital Plymouth,
Deutsches Herzzentrum TU München - Klinik für Herz- und Kreislauferkrankungen München,
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej Wroclaw,
Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow, Uttar Pradesh
Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow, Uttar Pradesh
Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi EAH Istanbul,
Duke University Medical Center Durham, North Carolina
ESIC Medical College and Hospital, Hyderabad Hyderabad, Telangana
Eastern Shore Rsrch Inst, LLC Fairhope, Alabama
Ehime Prefectural Central Hosp Ehime,
Elisabeth-TweeSteden Ziekenhuis Tilburg,
Emory University Hospital Atlanta, Georgia
Endeavor Health Glenbook Hosp Evanston, Illinois
Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC Acquaviva delle Fonti,
Erciyes University Cardiology Kayseri,
Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma Eskişehir, Odunpazari
Eskisehir Sehir Hospital Odunpazarı /Eskişehir,
Essentia Health Duluth, Minnesota
Evangelismos Hospital Athens,
Ewha Womans University Seoul Hospital Seoul,
FN u Sv. Anny Brno,
Fairview Health Services Maplewood, Minnesota
Fairview Health Services Maplewood, Minnesota
Fakultni nemocnice Brno Brno,
Fakultni nemocnice Kralovske Vinohrady Prague, Praha 10
Fakultni nemocnice Olomouc Olomouc, Olomoucký kraj
Fakultni nemocnice Plzen - Lochotin Plzen - Lochotín,
Flinders Medical Centre Bedford PK, South Australia
Fondazione IRCCS Policlinico San Matteo Pavia,
Fondazione IRCCS San Gerardo dei Tintori Monza,
Fondazione Policlinico Universitario Agostino Gemelli IRCS Roma,
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma,
Fortis Escorts Heart Institute, New Delhi New Delhi, National Capital Territory of Delhi
Fortis Hospital, Mohali Mohali, Punjab
Frankston Hospital Frankston, Victoria
Freeman Hospital, Newcastle Newcastle upon Tyne,
Fujita Health University Hospital_Cardiology Aichi,
Fukuoka University Hospital_Cardiology Fukuoka-shi, Fukuoka,
Fundacion Favaloro CABA, Buenos Aires, Argentina
Fundación Nuestra Señora del Rosario - Estudios Clínicos los Arroyos San Nicolás de los Arroyos, Buenos Aires
G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi
G. Kuppuswamy Naidu Memorial Hospital Coimbatore, Tamil Nadu
G. Kuppuswamy Naidu Memorial Hospital Coimbatore, Tamil Nadu
G.H. of Athens "Evaggelismos" Athens,
Gachon University Gil Medical Center Incheon,
Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College Kanpur, Uttar Pradesh
Gangdong Kyung Hee University Hospital Seoul,
Geisinger Medical Center Danville, Pennsylvania
Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt Thessaloniki,
General Hospital Of Eleusina Thriasio Eleusina,
General Hospital of Athens "Elpis" Ampelokipoi/Athens,
General Hospital of Athens "Laiko" Goudi, Athens,
General Hospital of Chios "Skilitsio" Chios,
General Hospital of Imathia Monada Veria Véroia,
General Hospital of Imathia Monada Veria Véroia,
General Hospital of Patras Agios Andreas Pátrai,
General Hospital of Thessaloniki PAPAGEORGIOU Nea Efkarpia, Thessaloniki
General Hospital of Tianjin Medical University-Endocrinology Tianjin, Tianjin Municipality
Genesis Health Care System Zanesville, Ohio
Glenfield Hospital Leicester,
Gold Coast University Hosptial Southport, Queensland
Golden Jubilee University National Hospital Glasgow,
Grande Ospedale Metropolitano Niguarda Milan,
Grandview Medical Center Birmingham, Alabama
Grey Nuns Community Hospital Edmonton, Alberta
Groene Hart Ziekenhuis, locatie Bleuland Gouda,
Group Euroclinic - Athens Euroclinic Athens,
Guangdong Provincial People's Hospital Guangzhou,
Guangdong Provincial People's Hospital Guangzhou,
HCA Research Institute McAllen, Texas
Hackensack Meridian Health Hackensack, New Jersey
Hadassah Ein Karam MC - Cardio Department Jerusalem,
Hadassah Mount Scorpus MC - Cardiology department Jerusalem,
Hamilton Health Sciences Corp, Ontario Hamilton, Ontario
Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine Hokkaido,
Hanaoka Seishu Memorial Hospital Hokkaido,
Hanyang University Seoul Hospital Seoul,
Health Sciences North Rsrch Inst Greater Sudbury, Ontario
Heart & Vascular Inst._Titus Mount Pleasant, Texas
Heart Center Rsrch_Hunstville Huntsville, Alabama
Hebei General Hospital Shijiazhuang, Hebei
Helios Klinikum Erfurt GmbH - 3. Med. Klinik - Kardiologie Erfurt,
Henry Dunant Hospital Center Athens,
Heritage Medical Research Clinic Calgary, Alberta
Herlev og Gentofte Hospital Hellerup, Capital Region
Hermosillo Heart Team Hermosillo, Sonora
Hillel Yafe MC - Cardiology Department Hadera,
Hippokration Hospital Athens,
Holy Cross Hospital Fort Lauderdale, Florida
Holy Name Medical Center Teaneck, New Jersey
Honor Health Scottsdale, Arizona
Hopital Sacre-Coeur de Montreal Montreal, Quebec
Hospices Civils de Lyon- Hopital Louis Pradel-1 Bron,
Hospital Agamenon Magalhães Recife, Pernambuco
Hospital Alvaro Cunqueiro de Vigo Vigo,
Hospital Angeles de Culiacan Culiacán, Sinaloa
Hospital Angeles de Xalapa Xalapa, Veracruz
Hospital Angeles de las Lomas México, State of Mexico
Hospital Canselor Tuanku Muhriz UKM Cheras,
Hospital Cardiologica Aguascalientes Aguascalientes, Aguascalientes
Hospital Civil De Guadalajara Fray Antonio Alcalde Guadalajara, Jalisco
Hospital Clinic i Provincial Barcelona,
Hospital Clinico San Carlos Madrid,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Clinico Universitario de Valladolid Valladolid,
Hospital Clinico Virgen de la Victoria Málaga,
Hospital Clinico de Santiago Santiago de Compostela,
Hospital De La Santa Creu I Sant Pau Barcelona,
Hospital Del Mar Barcelona,
Hospital Del Mar Barcelona,
Hospital Dr. Jose Maria Cullen Santa Fe,
Hospital Espanol De Mendoza Godoy Cruz, Mendoza Province
Hospital General Universitario Dr. Balmis Alicante,
Hospital General Universitario Dr. Balmis Alicante,
Hospital General de Mexico (HGM) Cuauhtémoc, México, D.F.
Hospital Germans Trias I Pujol Badalona,
Hospital Germans Trias I Pujol Badalona,
Hospital Gregorio Maranon Madrid,
Hospital Gregorio Maranon Madrid,
Hospital Israelita Albert Einstein Morumbi, São Paulo
Hospital Italiano Buenos Aires,
Hospital Italiano de la Plata La Plata, Buenos Aires
Hospital Juárez de Mexico Ciudad de México, D.F.,
Hospital Maternidade e Pronto Socorro Santa Lucia Poços de Caldas, Minas Gerais
Hospital Mãe de Deus - Porto Alegre Porto Alegre/RS,
Hospital Pulau Pinang George Town,
Hospital Queen Elizabeth II Sabak Bernam,
Hospital Raja Perempuan Zainab II Kelantan,
Hospital Raja Permaisuri Bainun Ipoh Ipoh, Perak
Hospital Ramon Y Cajal Madrid,
Hospital Ruy Azeredo Ltda Goiânia, Goiás
Hospital Serdang Kajang, Selangor
Hospital Serdang Kajang, Selangor
Hospital Sultanah Aminah Johor Bahru, Johor
Hospital Sultanah Bahiyah Alor Setar, Kedah,
Hospital São Lucas - PUC/RS Porto Alegre, Rio Grande do Sul
Hospital Tengku Ampuan Afzan Kuantan, Pahang
Hospital Univ. Virgen de la Arrixaca El Palmar, Murcia
Hospital Universitari Joan XXIII Tarragona,
Hospital Universitari Joan XXIII Tarragona,
Hospital Universitario Austral Pilar,
Hospital Universitario Austral Pilar,
Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey, Nuevo León
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de La Princesa Madrid, M
Hospital Universiti Kebangsaan Malaysia Kuala Lumpur,
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan Kota Bharu, Kelantan,
Hospital Virgen de la Arrixaca El Palmar, Murcia
Hospital das Clínicas da Universidade Federal do Triangulo Mineiro Uberaba, Minas Gerais
Hospital de Lleida "Arnau de Vilanova" Lleida,
Hospital del Centenario Rosario, Santa Fe,
Hospital do Coração do Brasil Brasília, Federal District
Houston Medical Center Houston, Texas
Houston Medical Center Houston, Texas
Houston Methodist Hospital Houston, Texas
Huashan Hospital Fudan University Shanghai,
Huashan Hospital Fudan University Shanghai,
Hyogo Medical University Hospital_Cardiovascular Medicine Hyōgo,
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo,
ICOT Istituto Marco Pasquali - UOC Cardiologia Latina,
II. interni klinika VFN - Kardiologie a angiologie Prague,
IKEM Prague,
IRCCS Policlinico San Donato San Donato Milanese, MI
Ikazia Ziekenhuis Rotterdam,
Illawarra Heart Health Centre Wollongong, New South Wales
Indiana University Health Methodist Hosptial Indianapolis, Indiana
Indraprastha Apollo Hospital, New Delhi New Delhi, National Capital Territory of Delhi
Inha University Hospital Incheon,
Inje University Haeundae Paik Hospital Busan,
Inova Fairfax Medical Campus Falls Church, Virginia
Ins Uni de Cardi et de PNA de Québec,
Inspira Health Mullica Hill, New Jersey
Instituto Cardiovascular Buenos Aires CABA, Buenos Aires
Instituto Dante Pazzanese de Cardiologia São Paulo,
Instituto Nacional de Cardiologia Ignacio Chavez Mexico City,
Instituto Nacional de Ciencias Medicas y Nutricion Tlalpan, Mexico City
Instituto de Cardiología de Corrientes Corrientes,
Instituto de Pesquisa Clinica de Campinas Campinas, São Paulo
Integral Pesquisa e Ensino Votuporanga,
Integral Pesquisa e Ensino Votuporanga,
Interbalkan Medical Center of Thessaloniki Thessaloniki,
Intercard Spolka z ograniczona odpowiedzialnoscia Pińczów,
Intercard Spolka z ograniczona odpowiedzialnoscia Pińczów,
Intercoastal Medical Group Sarasota, Florida
Intercoastal Medical Group Sarasota, Florida
Intermountain Medical Center Murray, Utah
Interventional Cardiology Medical Group West Hills, California
Irmandade Santa Casa de Misericórdia de Passos Passos, Minas Gerais
Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre,
Irmandade da Santa Casa de Misericórdia de Marília Marília, São Paulo
Ishikawa Prefectural Central Hospital_Cardiology Ishikawa,
Ishikiriseiki Hospital_Circulatory Medicine Osaka,
Istanbul University Cerrahpasa Medical Faculty Istanbul,
Jackson Heart Clinic Jackson, Mississippi
Jacobi Medical Center The Bronx, New York
Jadestone Clinical Research, LLC Silver Spring, Maryland
Japanese Red Cross Fukuoka Hospital_Cardiology Fukuoka,
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry, Tamil Nadu
Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh
Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh
Jeroen Bosch Ziekenhuis 's-Hertogenbosch,
Jersey City Med Center Jersey City, New Jersey
Jinan Central Hospital Affiliated to Shandong University Jinan, Shandong
Jmf Clínica Do Coração Ltda Aracaju,
Juntendo University Shizuoka Hospital Izunokuni-shi, Shizuoka,
Justice K S Hegde Charitable Hospital Mangaluru, Karnataka
KAT General Hospital of Attica Kifissia,
Kagawa Prefectural Central Hospital, Cardiovascular Medicine Takamatsu-shi, Kagawa,
Kaiser Permanente Viewridge Medical Offices San Diego, California
Kanto Rosai Hospital_Cardiology Kanagawa,
Kaplan MC - Cardiac Intensive Care Rehovot,
Kardiologisk Odense & Svendborg Svendborg,
Kartal Kosuyolu Yuksek Ihtisas EAH Istanbul,
Kasturba Medical College and Hospital, Manipal Udupi, Karnataka
Kath. St. Paulus GmbH - St Johannes Hospital Dortmund - Kardiologie Dortmund,
Kayseri City Hospital Kayseri,
Kayseri City Hospital Kayseri,
Keimyung University Dongsan Hospital Daegu,
Kelowna Cardiology Res. Ltd. Kelowna, British Columbia
Kettering General Hospital Kettering,
Kettering Medical Center Kettering, Ohio
King George Hospital Visakhapatnam, Andhra Pradesh
King George's Medical University (KGMU) Lucknow, Uttar Pradesh
King George's Medical University (KGMU) Lucknow, Uttar Pradesh
Kings College Hospital London,
Kings College Hospital London,
Kingston General Hospital Kingston, Ontario
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie Rzeszów,
Klinikum Friedrichshafen GmbH - Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin Friedrichshafen,
Klinikum Fulda gAG - Med. Klinik I Fulda,
Klinikum Leverkusen gGmbH - Med. Klinik 1 Leverkusen,
Knoxville Heart Group Knoxville, Tennessee
Kocaeli University Medical Faculty İzmit,
Konstantopouleio G.H. of Athens, "Agia Olga" Athens,
Korea University Anam Hospital Seoul,
Korea University Guro Hospital Seoul,
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Ústní Nad Labem, Czechia
Krajská nemocice Liberec, a.s Liberec,
Krajská nemocnice T.Bati a.s. Zlín,
Kyunghee University Medical Center Seoul,
Kyungpook National University Hospital Daegu,
Kütahya Sağlık Bilimleri Üniversitesi Evliya Çelebi Research and Training hospital Kütahya,
Kütahya Şehir Hastanesi Kütahya,
LA BioMed Harbor UCLA Med Cenr Torrance, California
Lakshmi Hospital Palakkad, Kerala
Lalitha Super Specialities Hospital Guntur, Andhra Pradesh
Les Hopitaux de Chartres-Hopital Louis Pasteur Le Coudray,
Lincoln County Hospital Lincoln,
Lindner Center,Christ Hospital Cincinnati, Ohio
Lisie Hospital Kochi, Kerala
Lister Hospital Stevenage,
Liver Ins@ Mthdist DTX Med Cen Dallas, Texas
Liverpool Heart & Chest Hospital Liverpool,
Liverpool Hospital Liverpool,
Liverpool Hospital Liverpool,
Loma Linda University Faculty Medical Clinics Loma Linda, California
London Health Sciences Center Ontario London, Ontario
Louis Stokes Clvlnd VA Med Ctr Cleveland, Ohio
Lyell McEwin Hospital Elizabeth Vale, South Australia
MHAT "Dr. Bratan Shukerov" Smolyan,
MHAT "Dr. Bratan Shukerov" Smolyan,
MHAT "Puls" AD Cardiology Department Blagoevgrad,
MHAT - Dr. Atanas Dafovski AD Kardzhali,
MHAT Haskovo AD Haskovo,
MHAT Heart and Brain Pleven,
MHAT Heart and Brain EAD Burgas,
MHAT MC-Sv Ivan Rilski EOOD Plovdiv,
MHAT Southwest Hospital OOD Sandanski,
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt,
Maasstad Ziekenhuis Rotterdam,
Maine Medical Center Bramhall Portland, Maine
Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana
Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana
Marengo CIMS Hospital Ahmedabad, Gujarat
Marmara University Medical Faculty Istanbul,
Matsuyama Red Cross Hospital_Department of Cardiovascular Medicine Ehime,
Max Super Speciality Hospital, Saket New Delhi, National Capital Territory of Delhi
Mayo Clinic Arizona Phoenix, Arizona
Mayo Clinic Jacksonville Jacksonville, Florida
McGuire VA Medical Center Richmond, Virginia
McLaren Bay Region Bay City, Michigan
McLaren Greater Lansing Lansing, Michigan
McLaren Macomb Health Care Mount Clemens, Michigan
McLaren Northern MI Hosp Petoskey, Michigan
Meander Medisch Centrum Amersfoort,
MedStar Hlth Res Institute Clinton, Maryland
MedStar Hlth Res Institute Clinton, Maryland
Medical College & Hospital, Kolkata Kolkata, West Bengal
Medical College & Hospital, Kolkata Kolkata, West Bengal
Medicover Hospitals, Visakhapatnam MVP Visakhapatnam, Andhra Pradesh
Medisch Centrum Haaglanden Locatie Westeinde Ziekenhuis The Hague,
Medisch Spectrum Twente Enschede,
Medizinische Hochschule Hannover - Kardiologie und Angiologie Hanover,
Meir MC - Cardiology department Kfar Saba,
Memorial Healthcare Owosso, Michigan
Mercy Gilbert Medical Center Gilbert, Arizona
Mercy Health - St. Vincent Medical Center Toledo, Ohio
Mercy Research Springfield, Missouri
MercyOne NE Iowa Fam Med & Res Waterloo, Iowa
Mersin City Hospital Mersin,
Mersin University Cardiology Mersin,
Methodist Healthcare System of San Antonio San Antonio, Texas
Methodist Physicians Clinic Omaha, Nebraska
MetroHealth Medical Center Cleveland, Ohio
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Athens,
Mhat "Nch" Sofia,
MidMic Medical Cntr - Midland Midland, Michigan
Midwest Cardiovascu Rsrch Foundation Elkhart, Indiana
Midwest Heart and Vascular Specialists Overland Park, Kansas
Midwest Heart and Vascular Specialists Overland Park, Kansas
Miedziowe Centrum Zdrowia s.a. Lubin,
Missouri Cardiovascular Specialist Columbia, Missouri
Mito Saiseikai General Hospital_Cardiology Ibaraki,
Miyazaki Medical Association Hospital Miyazaki, Miyazaki
Miyazaki Medical Association Hospital_Cardiology Miyazaki, Miyazaki
Mobile Heart USA Health Cardiology Clinic Mobile, Alabama
Monument Health Clinical Rsrch Rapid City, South Dakota
Morriston Hospital Swansea,
Moses H. Cone Mem Hosp Greensboro, North Carolina
Mount Sinai Morningside New York, New York
Multi-Profile Hospital For Active Treatment - City Clinic - Sveti Georgi EOOD Montana,
Multicare Health System Tacoma, Washington
Multidisciplinary Hospital For Active Treatment Cardiolife Ltd. Lovech,
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo,
Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD Gotse Delchev,
Musgrove Park Hospital Taunton,
Myongji Hospital Goyang-si, Gyeonggi-do
NC Heart and Vascular Research Raleigh, North Carolina
NHO Kure Medical Center and Chugoku Cancer Center Kure-shi, Hiroshima,
NUPEC Cardio Belo Horizonte,
NYU Grossman School of Med New York, New York
Nanfang Hospital, Southern Medical University Guangzhou,
Nanfang Hospital, Southern Medical University Guangzhou,
Nanjing Drum Tower Hospital Nanjing,
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw,
National Heart Institute Beverly Hills, California
National Heart Institute Beverly Hills, California
National Hospital Organization Kumamoto Medical Center_Cardiology Kumamoto,
Necmettin Erbakan University Hospital Konya,
Nemocnice AGEL Třinec-Podlesí a.s. Třinec,
Nemocnice Na Homolce Prague,
Nemocnice Pardubickeho kraje a.s. Pardubice,
Nemocnice České Budějovice a.s. České Budějovice,
Nepean Hospital Kingswood, New South Wales
New Brunswick Heart Centre Saint John, New Brunswick
New Cross Hospital Wolverhampton,
Niagara Health System St. Catharines, Ontario
Nil Ratan Sircar Medical College and Hospital Kolkata, West
Nimits Hospital Athens,
Nishinomiya Watanabe Cardiovascular Cerebral Center_Cardiovascular Medicine Hyōgo,
Noordwest Ziekenhuisgroep Alkmaar,
Nordsjællands Hospital Hillerød,
North Kansas City Hospital Kansas City, Missouri
North Mississippi Medical Center Tupelo, Mississippi
Northeast Georgia Medical Ctr Gainesville, Georgia
Northern General Hospital Sheffield,
Northern Health Epping, Victoria
Northern Light Eastern Maine Medical Center Bangor, Maine
Novant Hlth Cardio - Kimel Park Winston-Salem, North Carolina
Nuevo Hospital Civil "Dr. Juan I. Menchaca" Guadalajara, Jalisco
Nuevo Hospital Civil "Dr. Juan I. Menchaca" Guadalajara, Jalisco
OLVG Oost Amsterdam,
OSF HealthCare_Cardiovasc Inst Rockford, Illinois
Odense Universitetshospital, Kardiologisk afd. Odense C,
Ondokuz Mayıs Universitesi Tıp Fakültesi Samsun,
Osaka General Medical Center_Cardiology Osaka,
Osmania General Hospital Hyderabad, Telangana
Ospedale Civile dell'Annunziata Cosenza,
Ospedale Isola Tiberina Gemelli Isola Rome,
Ospedale Maggiore Carlo Alberto Pizzardi Bologna,
Ospedale Misericordia Grosseto Grosseto,
Ospedale Policlinico San Martino Genoa, Liguria
Ospedale Sandro Pertini - UOC Cardiologia Rome,
Ospedale Sant'Andrea - Cardiology La Spezia,
Overton Brooks V.A. Medical Center Shreveport, Louisiana
Overton Brooks V.A. Medical Center Shreveport, Louisiana
PUCCAMP - Hospital e Maternidade Celso Pierro Campinas, São Paulo
Pan-Arcadian General Hospital of Tripoli Evangelistria Tripoli,
Parkway Cardiology Associates, PC Oak Ridge, Tennessee
Peking University First Hospital-Cardiology Beijing, Beijing Municipality
Peking University Third Hospital Beijing, Beijing Municipality
Penn State Hershey Medical Center Hershey, Pennsylvania
Penn State Hlth Holy Spirit Med Ctr Camp Hill, Pennsylvania
PharmaTex Research, LLC Amarillo, Texas
Podhalanski Szpital Specjalistyczny Nowy Targ,
Policlinico Casilino - Cardiologia e UTIC Rome,
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh Chandigarh,
Prairie Cardiovascular Consultants, Ltd. Springfield, Illinois
Presidio Ospedaliero di Rivoli Rivoli, To
Prince of Wales Hospital_Randwick Randwick, New South Wales
Princess Alexandra Hospital Queensland, Queensland
Princess Alexandra Hospital Queensland, Queensland
Prism Hlth Carolina Card Cons Greenville, South Carolina
ProMedica Toledo, Ohio
Prolato Clinical Research Cntr Houston, Texas
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do
QE II Health Sciences Centre Halifax, Nova Scotia
Queen Alexandra Hospital Portsmouth,
Queen Alexandra Hospital Portsmouth,
Rabin MC -Beilinson - Cardiac intensive unit Petah Tikva,
Radboudumc Nijmegen, Gelderland
Ramaiah Memorial Hospital Bengaluru, Karnataka
Rambam MC - Cardiac Intensive Care Unit Haifa,
Reading Hospital West Reading, Pennsylvania
Regina General Hospital Regina, Saskatchewan
Regions Hospital Saint Paul, Minnesota
Reid Physician Associates Richmond, Indiana
Renmin Hospital of Wuhan University-Cardiology Wuhan, Hubei
Rhode Island Hospital Providence, Rhode Island
Rhythm Heart Institute Vadodara, Gujarat
Rhön-Klinikum AG - Zentralklinik Bad Berka - Kardiologie Bad Berka,
Rigshospitalet Copenhagen,
Rijnstate Ziekenhuis Arnhem,
Robert Packer Hospital Sayre, Pennsylvania
Robert-Bosch-Krankenhaus GmbH Stuttgart Stuttgart,
Royal Adelaide Hospital Cardiovascular Clinical Trials Adelaide, South Australia
Royal Alexandra Hospital Edmonton, Alberta
Royal Bournemouth Hospital Bournemouth, Dorset
Royal Brisbane and Women's Hospital Herston, Queensland
Royal Brompton and Harefield Hospitals Harefield, Middlesex
Royal Cornwall Hospital (Treliske) Truro, Cornwall
Royal Infirmary of Edinburgh - Cardiology Edinburgh,
Royal Perth Hospital Perth, Western Australia
Royal University Hospital Saskatoon, Saskatchewan
Royal Victoria Regional Health Centre Barrie, Ontario
S Denver Cardiology Associates Littleton, Colorado
S.P. Medical College & Associated Group of Hospitals Bikaner, Rajasthan
SCANMED Spółka Akcyjna Kutno,
SCANMED Spółka Akcyjna Kutno,
SCANMED Spółka Akcyjna Kutno,
SCANMED Spółka Akcyjna Kutno,
SCANMED Spółka Akcyjna Kutno,
SCB Medical College and Hospital Cuttack, Odisha
SHATC - Cardiolife OOD Varna,
SHATC - Medica Kor EAD Rousse,
SHATC - Yambol EAD Yambol,
SMC Heart Institute and IVF Research Centre Raipur, Chhattisgarh
SMS Medical College & Attached Hospitals Jaipur, Rajasthan
Sahyadri Super Speciality Hospital Pune,
Saint Elizabeth Medical Center Edgewood, Kentucky
Saint Joseph's Hospital Health Center Liverpool, New York
Saint Paul's Hospital Vancouver, British Columbia
Saint Thomas Hospital Nashville, Tennessee
Saiseikai Yokohamashi Nanbu Hospital_Cardiology Yokohama-shi, Kanagawa,
Saiseikai Yokohamashi Tobu Hospital_Cardiology Kanagawa,
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki,
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie Rzeszów, Podkarpackie Voivodeship
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Krakow,
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Puławy, Lublin Voivodeship
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Swidnicy Swidnica,
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Swidnicy Swidnica,
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Ostrowi Mazowieckiej Ostrów Mazowiecka,
San Diego Cardiac Center San Diego, California
San Francisco V.A. Medical Center San Francisco, California
Sanatorio Finochietto Buenos Aires,
Sanatorio Finochietto Buenos Aires,
Sanatorio Güemes CABA, City of Buenos Aires
Sanatorio Modelo Quilmes Quilmes, Buenos Aires
Sanatorio Parque Rosario, Santa Fe Province
Sanford Health - Fargo Fargo, North Dakota
Sanford Health - Fargo Fargo, North Dakota
Sanford Research Sioux Falls, South Dakota
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh
Sarawak Heart Centre Kota Samarahan, Sarawak
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research Ahmedabad, Gujarat
Sentara Bayside Hospital Norfolk, Virginia
Seoul National University Bundang Hospital Seongnam-si,
Seoul National University Hospital Seoul,
Servicios Integrales Nova de Monterrey San Nicolás de los Garza,
Servicios Integrales Nova de Monterrey San Nicolás de los Garza,
Seth GS Medical College & KEM Hospital Mumbai, Maharashtra
Severance Hospital, Yonsei University Health System Seoul,
Shamir MC - Cardio and Pedi Beer Yaakov,
Sheba MC - Cardiology Clinical Research Unit Tel Litwinsky,
Shengjing Hospital of China Medical University Shenyang, Liaoning
Shengjing Hospital of China Medical University-Cardiology Shenyang, Liaoning
Shiga University of Medical Science Hospital_Cardiology Shiga,
Shri B. D. Mehta Mahavir Heart Institute Surat, Gujarat
Shri Krishna Hrudayalaya & Critical Care Centre Nagpur, Maharashtra
Shri Mahant Indiresh Hospital Dehradun, Uttarakhand
Sichuan Provincial People's Hospital-Cardiology Chengdu, Sichuan
Sir Ganga Ram Hospital New Delhi, National Capital Territory of Delhi
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou,
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou,
Sismanogleio General Hospital Marousi,
Sourasky MC - Cardio Vascular Research Center Tel Aviv,
South Oklahoma Heart Research, LLC Oklahoma City, Oklahoma
South Oklahoma Heart Research, LLC Oklahoma City, Oklahoma
Southlake Regional Hlth Centre Newmarket, Ontario
Specialized Hospital For Active Cardiology Treatement Cardiolife OOD Varna,
Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów,
Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów,
Specjalistyczny Szpital Miejski im. M.Kopernika w Toruniu Torun,
Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka
Sri Ramachandra Medical Centre Chennai, Tamil Nadu
Sri Ramachandra Medical Centre Chennai, Tamil Nadu
Ss. Annunziata Chieti, Abruzzo
St Francis Hospital Lindner Research Center Roslyn, New York
St Francis Hospital Lindner Research Center Roslyn, New York
St. Boniface Hospital Winnipeg, Manitoba
St. Boniface Hospital Winnipeg, Manitoba
St. Luke's Idaho Cardiology Associates Meridian, Idaho
St. Michael's Hospital Toronto, Ontario
St.Jude Clin-NovantHemby Child Charlotte, North Carolina
St.Mary's Hospital_Cardiology Fukuoka,
Sterling Hospitals, Race Course Road Vadodara, Gujarat
Stony Brook University Hospital Stony Brook, New York
Städt. Klinikum Dresden - 2. Medizinische Klinik Dresden,
Sultan Ahmad Shah Medical Centre @IIUM Kuantan, Pahang
Sunnybrook Health Sciences Centre Toronto, Ontario
Sunshine Coast University Hospital Birtinya, Queensland
Sunshine Hospital St Albans, Victoria
Swedish Medical Center_Seattle Seattle, Washington
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Warsaw,
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Warsaw,
Szpital Miejski Nr 4 w Gliwicach Sp. z o.o., Oddzial Kardiologii Gliwice, Silesian Voivodeship
Szpital Uniwersytecki Nr 2 im. Dr. Jana Biziela Bydgoszcz,
Szpital Wolski im. dr Anny Gostyńskiej Sp. z o.o. Warsaw,
Szpitale Pomorskie Sp. z o.o. Gdynia, Pomeranian Voivodeship
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan Adana,
TEDA International Cardiovascular Hospital-Cardiovascular Tianjin, Tianjin Municipality
Teda International Cardiovascular Hospital Tianjin, Tianjin Municipality
Teikyo University Hospital_Cardiology Tokyo,
Tennova HC Turkey Creek MC Knoxville, Tennessee
Tergooi, locatie Hilversum Hilversum,
Texas Heart Inst Medical Ctr Houston, Texas
The 1st Affiliated Hospital of WMU-Cardiology Wenzhou, Zhejiang
The Alfred Hospital Melbourne, Victoria
The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheonsi Weonmigu,
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul,
The First Affiliated Hospital of Harbin Medical University Harbin,
The First Affiliated Hospital of Harbin Medical University Harbin,
The First Affiliated Hospital of WMU-Cardiology Wenzhou, Zhejiang
The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular Xi'an, Shaanxi
The First Affiliated hospital of Fujian Medical University Fuzhou, Fujian
The Heart House Haddon Heights Haddon Heights, New Jersey
The James Cook University Hospital Middlesbrough,
The Madras Medical Mission Chennai, Tamil Nadu
The New York Hospital Brooklyn, New York
The People's Hospital of Guangxi Zhuang Autonomous Region Nanning, Guangxi
The People's Hospital of Liaoning Province Shenyang, Liaoning
The People's Hospital of Liaoning Province-Cardiology Shenyang, Liaoning
The Prince Charles Hospital Chermside, Queensland
The Sakakibara Heart Institute of Okayama_Department of Cardiovascular Medicine Okayama,
The Second Affiliated Hospital Of Chongqing Medical University Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Nanjing Medical university Nanjing,
The Second Xiangya Hospital of Central South University Changsha,
Tianjin People's Hospital Tianjin, Tianjin Municipality
Toho University Sakura Medical Center_Cardiology Chiba,
Tohoku University Hospital, Cardiovascular Sendai-shi, Miyagi,
Tokai University Hospital_Cardiology Kanagawa,
Tokai University Hospital_Cardiology Kanagawa,
Tokat Gaziosmanpaşa Üniversitesi Tıp Fakültesi Hastanesi Tokat Province,
Tokushima Prefectural Central Hospital_Cardiology Tokushima,
Torbay Hospital Torquay,
Torrance Memorial Medical Center Torrance, California
Townsville University Hospital Douglas,
Trakya University Edirne,
Trinity Health Michigan Heart Ypsilanti, Michigan
Trinity Health Oakland Hospital Pontiac, Michigan
Trinity Medical Group Minot, North Dakota
Trinity Medical WNY, PC Buffalo, New York
Tsuchiura Kyodo General Hospital_Internal Medicine Ibaraki,
Tsukuba Medical Center Hospital_Department of Cardiology Tsukuba-shi, Ibaraki,
Tzaneio General Hospital of Piraeus Piraeus,
U.G.H of Athens "Attikon" Chaidari, Athens,
UCSD Medical Center San Diego, California
UF Hlth Jacksonville Jacksonville, Florida
UHN-Toronto General Hospital Toronto, Ontario
UHN-Toronto General Hospital Toronto, Ontario
UMC Groningen Groningen,
UMC of Southern Nevada Las Vegas, Nevada
UMHAT "Deva Maria" EOOD Burgas,
UMHAT "Sveta Marina" EAD Varna,
UMHAT Pulmed, Department of Cardiology Plovdiv,
UMHAT Sofiamed Sofia,
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv,
UNC Hospital HVC_Meadowmont Chapel Hill, North Carolina
UT Health University of Texas Houston, Texas
Unidad Medica de Alta Especialidad No. 71 IMSS Torreón, Coahuila
Unidad Medica de Alta Especialidad No. 71 IMSS Torreón, Coahuila
Uniklinik Klinikum Bielefeld - Kardiologie und Internist. Intensivmedizin Bielefeld,
Uniklinik Regensburg - Innere Medizin II Regensburg,
Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden,
Uniklinik Tübingen - Innere Med. III Kardiologie und Angiologie Tübingen,
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie Heidelberg,
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Cardiology Wuhan, Hubei
Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa/Thessaly, Greece
Univ of Alberta Hosp Edmonton Edmonton, Alberta
Univ of Mississippi Med Center Jackson, Mississippi
Universiti Teknologi MARA, Sungai Buloh Campus Sungai Buloh, Selangor
University General Hospital of Ioannina,Internal Medicine Ioannina,
University General Hospital of Ioannina,Internal Medicine Ioannina,
University Hospitals of Cleveland Medical Center Elyria, Ohio
University Malaya Medical Centre Kuala Lumpur,
University Medical Center New Orleans New Orleans, Louisiana
University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD Sofia,
University Of Washington_Seattle Seattle, Washington
University of CO - Division of Cardiology Aurora, Colorado
University of Californ LA-UCLA Los Angeles, California
University of California Irvine Irvine, California
University of Cincinnati/UC Health Cincinnati, Ohio
University of Florida Gainesville, Florida
University of Kansas Hospital Kansas City, Kansas
University of Louisville Louisville, Kentucky
University of Ottawa Heart Ins Ottawa, Ontario
University of Rochester Rochester, New York
University of Texas Medical Branch Galveston, Texas
University of Texas Southwestern Medical Center Dallas, Texas
University of Toledo Toledo, Ohio
University of Virginia Charlottesville, Virginia
Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie Düsseldorf,
Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main,
Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau,
Universitätsklinikum Hamburg-Eppendorf - University Medical Center Hamburg-Eppendorf Hamburg,
Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie Leipzig,
Universitätsklinikum Mannheim - 1. Medizinische Klinik Mannheim,
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie Szczecin,
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan,
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan,
Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi Lodz,
Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok,
Uniwersytecki Szpital Kliniczny w Opolu Opole,
Uniwersytecki Szpital Kliniczny w Opolu Opole,
Uniwersyteckie Centrum Kliniczne (UCK) Gdansk,
Uniwersyteckie Centrum Kliniczne WUM Warsaw,
Uniwersyteckie Centrum Kliniczne WUM Warsaw,
VA Greater Los Angeles Hlthcare System Los Angeles, California
VA Medical Center_Minneapolis Minneapolis, Minnesota
VA Medical Center_Salem Salem, Virginia
Valley Clinical Trials Covina, California
Valley Clinical Trials Covina, California
Valley Health Link Winchester, Virginia
Vancouver General Hospital Vancouver, British Columbia
Vanderbilt University Medical Center Nashville, Tennessee
Vanderbilt University Medical Center Nashville, Tennessee
Vardhaman Mahavir Medical College & Safdarjung Hospital New Delhi, National Capital Territory of Delhi
Vijan Hospital & Research Centre Nashik, Maharashtra
Virginia Commonwealth University Health System Richmond, Virginia
Virtua Health Camden, New Jersey
WMU Homer Stryker MD School of Medicine Kalamazoo, Michigan
Wake Forest Uni Hlth Sciences High Point, North Carolina
Washington University School of Medicine_St. Louis St Louis, Missouri
Wayne State University/University Health Center Detroit, Michigan
West China Hospital Sichuan University-Cardiology Chengdu, Sichuan
Westchester Medical Center Valhalla, New York
Westchester Medical Center Valhalla, New York
William Harvey Hospital Ashford, Kent
William Harvey Hospital Ashford, Kent
William Osler Hel Bra Civic Hs Brampton, Ontario
Winter Haven Hospital Winter Haven, Florida
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemyśl,
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biała Podlaska,
Wojewodzki Szpital Specjalistyczny We Wroclawiu Wroclaw,
Wojewodzki Szpital Specjalistyczny We Wroclawiu Wroclaw,
Wojewodzki Szpital Zespolony W Elblagu samodzielny publiczny zakład opieki zdrowotnej Elblag,
Wojewodzki Szpital Zespolony W Elblagu samodzielny publiczny zakład opieki zdrowotnej Elblag,
Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego, Lodz,
Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego, Lodz,
Wojewódzki Szpital Specjalistyczny im. NMP w Częstochowie Częstochowa,
Wojewódzki Szpital Zespolony im. dr. Romana Ostrzyckiego w Koninie Konin,
Wolfson MC - The Heart Institute Holon,
Wonju Severance Christian Hospital Gangwon-do,
Wright State University Fairborn, Ohio
Xiangya Hospital Central-South University Changsha, Hunan
Yale Ctr for Clin Invest New Haven, Connecticut
Yokohama City University Hospital Kanagawa,
Yokohama City University Medical Center_Cardiovascular Center Kanagawa,
Yokohama Municipal Citizen's Hospital_Cardiology Kanagawa,
Zespol Zakladow Opieki Zdrowotnej w Ostrowie Wielkopolskim Ostrów Wielkopolski, Greater Poland Voivodeship
Zespół Zakładów Opieki Zdrowotnej w Ostrowie Wielkopolskim Ostrów Wielkopolski, Greater Poland Voivodeship
Zhejiang Hospital, Zhejiang University School of Medicine Hangzhou,
Zhejiang Hospital-Cardiology Hangzhou, Zhejiang
Zhongda Hospital Southeast University Nanjin,
Zhongda Hospital, Southeast University Nanjing,
Zhongshan Hospital, Fudan University-Cardiology Shanghai, Shanghai Municipality
Śródmiejskie Centrum Kliniczne,II Oddział Kardiologii MSB, Klinika Chorób Serca CMKP Warsaw,

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

Nichol Nunn - nichol.nunn@hsc.utah.edu

NCT04177914
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Inclusion Criteria:

• Corrected age \<104 weeks and 0 days, AND
• Child is ≥ 37 weeks post menstrual age, AND
• Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures * Upgaze paresis/palsy (sundowning) * CSF leak * Papilledema * Tense pseudomeningocele or tense fluid along a track * Vomiting or irritability, with no other attributable cause * Bradycardias or apneas, with no other attributable cause * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND
• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion Criteria:

• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX * Closure of one or both foramina of Monro * Thick floor of third ventricle (≥ 3mm) * Narrow third ventricle (\<5mm) * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
PROCEDURE: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), DEVICE: Ventriculoperitoneal Shunt
Hydrocephalus
Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization
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Alberta Children's Hospital Calgary, Alberta Ruksana Rashid, MBBS MPH MSc - (rsrashid@ucalgary.ca)
Arnold Palmer Hospital for Children Orlando, Florida Richard Guerrero - (richard.guerrero@orlandohealth.com)
British Columbia Children's Hospital Vancouver, British Columbia Annika Weirs - (annika.weir@cw.bc.ca)
Children's Hospital Colorado Aurora, Colorado Susan Staulcup, 80045 - (SUSAN.STAULCUP@UCDENVER.EDU)
Children's Hospital of Los Angeles Los Angeles, California Helen Berroya - (hberroya@chla.usc.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Kimberly Diamond, BS, BA - (diamondkl@upmc.edu)
Children's Of Alabama Birmingham, Alabama Anastasia Smith, MPH - (Anastasia.Smith@childrensal.org)
Johns Hopkins Children's Center Baltimore, Maryland Sydney White - (swhit128@jh.edu)
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee Julia Loes - (julia.loes@vumc.org) Stephen Gannon - (stephen.r.gannon@vumc.org)
Nationwide Children's Hospital Columbus, Ohio Jared Haught - (Jared.Haught@nationwidechildrens.org)
Phoenix Children's Hospital Phoenix, Arizona Bethany Norton - (bnorton1@phoenixchildrens.com)
Primary Children's Hospital Salt Lake City, Utah Alli Ludwick - (allison.ludwick@hsc.utah.edu)
Seattle Children's Hospital Seattle, Washington Jessica Becerra - (Jessica.Becerra@seattlechildrens.org)
St. Louis Children's Hospital St Louis, Missouri Diego Morales, MS - (moralesd@wudosis.wustl.edu) Mary Goldschmidt - (goldschmidt@wustl.edu)
Texas Children's Hospital Houston, Texas Edgardo Santisbon - (exsantis@texaschildrens.org)
The Hospital for Sick Children Toronto, Ontario Homa Ashrafpour - (homa.ashrafpour@sickkids.ca)
The Pennsylvania State University University Park, Pennsylvania
Trustees of Indiana University Indianapolis, Indiana Mariah Shirrell - (mkillin@iu.edu)
Virginia Commonwealth University Richmond, Virginia
Wolfson Children's Hospital Jacksonville, Florida Asmaa Hatem - (Asmaa.Hatem@jax.ufl.edu)
Yale University New Haven, Connecticut

ASSESS ALL ALS Study

ALL ALS Patient Navigator - info@all-als.org

NCT06578195
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Inclusion Criteria for ALS participants:
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• Diagnosis of ALS by a physician
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Inclusion Criteria for control participants:
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
• No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member\*\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll. * \*\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Exclusion Criteria for all participants:
• Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \<= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.
• Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment. Exclusion Criteria for participants undergoing optional Lumbar Puncture
• Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).
• Allergy to Lidocaine or other local anesthetic agents.
• Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
• Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
• Current pregnancy based on participant self-report
• Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.
Amyotrophic Lateral Sclerosis
ALS, Amyotrophic Lateral Sclerosis, biomarker, observational
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Barrow Neurological Institute Phoenix, Arizona Christopher Shiver - (fulton.research@dignityhealth.org)
CHALS-CCT, University of Puerto Rico, Medical Sciences Campus San Juan, Puerto Rico Frances M Aponte - (frances.aponte2@upr.edu)
Columbia University New York, New York Ben Hoover - (alsresearch@cumc.columbia.edu)
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire Gina Kersey - (neuroresearch@hitchcock.org)
Duke University Durham, North Carolina Duke Research Team - (alsresearch@dm.duke.edu)
Georgetown University Washington D.C., District of Columbia Cassandra Holmes - (cassie.holmes@georgetown.edu)
Henry Ford Health Detroit, Michigan Maria Stotland - (mstotla1@hfhs.org)
Hospital for Special Care New Britain, Connecticut Sabine Lebel-Hardenac - (shardenack@hfsc.org)
Indiana University Indianapolis, Indiana Lisa Grinstead - (lgrinste@iu.edu) Patti Hogan - (hoganpr@iu.edu)
John Hopkins University Baltimore, Maryland Delayne Willie - (dwillie2@jh.edu)
Massachusetts General Brigham Boston, Massachusetts Miranda Duncan - (mghassessallals@mgb.org)
Mayo Clinic Jacksonville, Florida Jany Dagher - (dagher.jany@mayo.edu) Jeffery Gainer - (gainer.jeffery@mayo.edu)
Nih/Ninds Bethesda, Maryland Katelyn Porter - (katelyn.porter@nih.gov)
Northwestern University Chicago, Illinois Aeryn Hopwood - (aeryn.hopwood@northwestern.edu)
Ohio State University Columbus, Ohio Alexander Michael - (alsresearch@osumc.edu)
Penn State Health Hershey, Pennsylvania Michele Hare - (nervemuscle@pennstatehealth.psu.edu)
Providence ALS Center Portland, Oregon Kimberly Perry - (kimberly.perry2@providence.org)
Saint Alphonsus Regional Medical Center Boise, Idaho Helena Snider - (neuro.research@saintalphonsus.org)
Temple University Philadelphia, Pennsylvania John Furey - (tuf40109@temple.edu)
Texas Neurology Dallas, Texas Haley Rucker - (hrucker@texasneurology.com) Reham Azab - (razab@texasneurology.com)
University of Alabama Birmingham Birmingham, Alabama Melanie Benge - (melaniebenge@uabmc.edu)
University of California San Diego La Jolla, California Gil Gutierrez - (grg005@health.ucsd.edu)
University of California, Irvine Irvine, California Rosa Gonzalez - (rosaig1@hs.uci.edu)
University of California, San Francisco San Francisco, California Hannah George - (hannah.george@ucsf.edu)
University of Colorado Anschutz Medical Campus Aurora, Colorado Alexis Shepardson - (neuroresearch@cuanschutz.edu)
University of Michigan Ann Arbor, Michigan Caroline Piecuch - (carolinp@med.umich.edu)
University of Minnesota Minneapolis, Minnesota Julia Munoz - (munoz156@umn.edu)
University of Nebraska Medical Center Omaha, Nebraska Nathan McKain - (nmckain@unmc.edu)
University of Utah Salt Lake City, Utah Scott Redlin - (scott.redlin@utah.edu)
University of Washington Seattle, Washington Lila Brisk - (lbrisk@uw.edu)
Virginia Commonwealth University Richmond, Virginia Brianne Schibley-Laird - (brianna.schibleylaird@vcuhealth.org)
Washington University St Louis, Missouri Jesse Markway - (als@wustl.edu)

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

Mansoor Raza Mirza, MD - ACR-368-201ClinicalTrial@acrivon.com

NCT05548296
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Inclusion Criteria:
General
• Participant must be able to give signed, written informed consent.
• Participant must have histologically documented, high-grade endometrial cancer.
• Treatment History Requirements:
• Subject must have received prior platinum-based chemotherapy
• Subject must have received prior anti-PD-(L)1 therapy
• Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
• Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator) in a baseline tumor imaging that has been obtained within 28 days of the treatment start. Participant must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment.
• Arm 1 and 2 only: Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after written informed consent. Newly obtained is defined as a specimen taken after written informed consent is obtained, during the 28-day Screening period.
• Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.
• Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows:
• Alopecia is accepted.
• Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency).
• Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted.
• Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.
• Participant must have an estimated life expectancy of longer than 3 months.
• Participant must have adequate organ function at Screening, defined as:
• Absolute neutrophil count \> 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening.
• Hemoglobin ≥ 9.0 g/dL.
• Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening.
• Calculated creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.
• Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.
• Serum albumin ≥ 3 g/dL.
• Participant must have adequate coagulation profile as defined below if not on anticoagulation. If subject is receiving anticoagulation therapy, then subject must be on a stable dose of anticoagulation for ≥ 1 month:
• Prothrombin time within 1.5 x ULN.
• Activated partial thromboplastin time within 1.5 x ULN.
Exclusion Criteria:
General
• Participant with known symptomatic brain metastases requiring \> 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
• Participant has mesenchymal tumors of the uterus.
• Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded.
• Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
• Participants has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2.
• Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
• Participant has cardiovascular disease, defined as:
• Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted).
• History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT based on Fridericia's formula (QTcF) \> 450 msec (for men) or \> 470 msec (for women).
• Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction \< 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1).
• Participant has a history of major surgery within 4 weeks of Screening.
• Participant has experienced bowel obstruction related to the current cancer within the last 6 months or signs or symptoms of intestinal obstruction, which include nausea, vomiting, or objective radiologic finding of bowel obstruction in the last 4 weeks before the start of the treatment.
• Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368
DRUG: ACR-368, DRUG: Gemcitabine, DIAGNOSTIC_TEST: OncoSignature
Endometrial Adenocarcinoma
Endometrial Cancer, Endometrial Neoplasm, Ultralow dose gemcitabine, ACR-368
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Study Locations

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Location Contacts
Alaska Women's Cancer Center Anchorage, Alaska
American Oncology Partners of Maryland Pa Bethesda, Maryland
Arizona Oncology Associate, PC- HOPE Tucson, Arizona
Ascension St. Vicent Hospital, Inc. Indianapolis, Indiana
Carle Cancer Center Urbana, Illinois
Cedars Sinai Medical Center Los Angeles, California
City of Hope National Medical Center Duarte, California
Cleveland Clinic Foundation Cleveland, Ohio
Dana Farber Cancer Institute Boston, Massachusetts
Emory University Atlanta, Georgia
Firsthealth of The Carolinas Pinehurst, North Carolina
Florida Gynecologic Oncology/Regional Cancer Center Fort Myers, Florida
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fred Hutchinson Cancer Center Seattle, Washington
Froedtert and Medical College of Wisconsin Milwaukee, Wisconsin
Gabrail Cancer Center Canton, Ohio
HCA Midwest Kansas City, Missouri
Hoag Cancer Center Irvine, California
Holy Cross Hospital Fort Lauderdale, Florida
HonorHealth Scottsdale, Arizona
Huntsman Cancer Institute, University of Utah Salt Lake City, Utah
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey
Karmanos Cancer Institute Detroit, Michigan
LSU Health Sciences New Orleans, Louisiana
Laura & Isaac Perlmutter Cancer Center New York, New York
Memorial Sloan-Kettering Cancer Center New York, New York
Miami Valley Hospital South Centerville, Ohio
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida
Mount Sinai Health System New York, New York
National Institutes of Health, Clinical Center Bethesda, Maryland
New York Presbyterian Hospital-Columbia University Medical Center New York, New York
Northeast Georgia Medical Center Gainesville, Georgia
Northwest Cancer Specialists, P.C. Vancouver, Washington
Northwestern Medicine Chicago, Illinois
Ohio State University Columbus, Ohio
Oncology Associates of Oregon Eugene, Oregon
Oregon Health & Sciences University Portland, Oregon
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington
Rutgers Cancer Institute of Nj New Brunswick, New Jersey
Sanford Health Sioux Falls, South Dakota
Stanford Cancer Center Palo Alto, California
Stephenson Cancer Center at OU Health Oklahoma City, Oklahoma Ashley Willy - (phase1-referrals@ouhsc.edu)
Summit Cancer Center Spokane, Washington
Swedish Cancer Center Seattle, Washington
Texas Oncology Dallas, Texas
Texas Oncology-Dallas Presbyterian Hospital Dallas, Texas
Trials365, LLC Shreveport, Louisiana
UC Irvine Health Orange, California
UC San Diego Moores Cancer Center La Jolla, California
USC/Norris Comprehensive Cancer Center Los Angeles, California
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of California Los Angeles (UCLA) Los Angeles, California
University of California, Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Medicine Chicago, Illinois
University of Cincinnati Cancer Center Cincinnati, Ohio
University of Colorado Aurora, Colorado
University of Illinois Cancer Center Chicago, Illinois
University of Iowa Iowa City, Iowa
University of Massachusetts Chan Medical School Worcester, Massachusetts
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Rochester Medical Center Rochester, New York
University of South Alabama Mitchell Cancer Institute Mobile, Alabama
University of Texas Southwestern Medical Center Dallas, Texas
University of Texas, MD Anderson Cancer Center Houston, Texas
University of Virginia Health System Charlottesville, Virginia
Virginia Commonwealth University Richmond, Virginia
West Penn Hospital Pittsburgh, Pennsylvania
Women & Infants Hospital Providence, Rhode Island - (oncologyresearch@wihri.org)
Yale Cancer Center New Haven, Connecticut

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

Trial Registration Coordinator - clinicaltrials@cslbehring.com

NCT06524739
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Inclusion Criteria:

• Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
• Males and females aged ≥ 18 at the time of providing written informed consent.
• Diagnosis of post-COVID POTS, defined by both a preceding COVID-19 infection based on confirmed historical documentation and onset of POTS symptoms developing within 4 months after COVID-19 infection as defined per consensus criteria.
• COMPASS-31 score of at least 40 at the Screening visit.
• Positive confirmatory standardized standing test (ie, HR increase of ≥ 30 bpm \[≥ 40 bpm for participants aged 18 to 19 years\] within 10 minutes in the absence of orthostatic hypotension) at the Screening visit.
Exclusion Criteria:

• Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
• Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
• Prior diagnosis of or receiving current treatment at Screening for the following conditions (unless onset was related to the inciting POTS-associated COVID-19 infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders, and pre-existing psychiatric disorders
• Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection
BIOLOGICAL: IgPro20, BIOLOGICAL: Placebo
Post-COVID Postural Orthostatic Tachycardia Syndrome
POTS
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Arkansas Cardiology Clinic - Little Rock Little Rock, Arkansas
Bateman Horne Center Salt Lake City, Utah
Bernstein Clinical Research Center Cincinnati, Ohio
Center for Complex Neurology, EDS & POTS Phoenix, Arizona
Ciussse-Chus Sherbrooke,
Duke University Medical Center Durham, North Carolina
Dysautonomia Clinic Buffalo, New York
Hightower Clinical Oklahoma City, Oklahoma
Hope Research Network Miami, Florida
Johns Hopkins Bayview Medical Center PMR Baltimore, Maryland
LSU Health Sciences Center New Orleans, Louisiana
Libin Cardiovascular Institute University of Calgary Calgary,
Mass General Brigham (Massachusetts General Hospital) Belmont, Massachusetts
Mayo Clinic Arizona Phoenix, Arizona
McGill University Health Centre Montreal, Quebec
Metrodora Institute West Valley City, Utah
NYU Langone Health South Shore Neurologic Associates Patchogue, New York
National Jewish Health Denver, Colorado
Penn Presbyterian Medical Center Philadelphia, Pennsylvania
Profound Research LLC at Millennium Affiliated Physicians Farmington Hills, Michigan
Prolato Clinical Research Center Houston, Texas
Sunbeam Clinical Research McKinney, Texas
UC San Diego Health San Diego, California
UT Austin Dell Medical School Austin, Texas
University Hospital Cleveland Medical Center Cleveland, Ohio
University Of Texas Health Science Center San Antonio, Texas
University of Alabama Hospital at Birmingham Birmingham, Alabama
University of Alberta Hospital Edmonton, Alberta
University of California Irvine Irvine, California
University of Texas Southwestern Medical Center Dallas, Texas
VCU Health Richmond, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Velocity Clinical Research - Hampton Hampton, Virginia
Velocity Clinical Research - Lincoln Lincoln, Nebraska
Velocity Clinical Research - Union Union, South Carolina
Velocity Clinical Research, Metairie New Orleans, Louisiana
Velocity Clinical Research, Savannah Savannah, Georgia
Well Pharma Medical Research, Corp Miami, Florida

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

NCT05882058
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Inclusion criteria:
• Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Part 1: Histologically or cytologically confirmed, cancer of the following histologies: * Small cell lung cancer (SCLC) * Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC)) * Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue. Patients must have progressed or recurred after standard of care therapy * SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. * Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. * epNEC/LCNEC: after at least one platinum-based regimen. Part 2: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.
• Part 1: Availability of archival tumour tissue sample Part 2: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples.
• Adequate organ function as defined in the protocol.
• All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
• Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information Exclusion criteria:
• Untreated or symptomatic brain metastases. (Part 2: with mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria: * Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532. * Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
• Presence of leptomeningeal disease or, part 2: epidural disease including spinal cord compression.
• Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). Part 2: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.
• Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
• Prior anti-cancer therapy: * Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
• Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
• Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
• Unresolved toxicity from prior anti-tumour therapy, defined as per protocol. Further exclusion criteria apply.
DRUG: BI 764532, dose 1, DRUG: BI 764532, dose 2
Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma
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960 Hospital of the Chinese People's Liberation Army Jinan, Boehringer Ingelheim - (china@bitrialsupport.com)
Aichi Cancer Center Hospital Aichi, Nagoya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Asan Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asklepios Fachkliniken München-Gauting Gauting,
Chang Gung Memorial Hospital, Linkou Taoyuan District,
Dana-Farber Cancer Institute Boston, Massachusetts
Evangelische Lungenklinik Berlin Berlin,
Freeman Hospital High Heaton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
HOP Civil Strasbourg,
HOP Intercommunal Créteil,
Hopital Cochin Paris,
Hospital CUF Descobertas-Lisboa-69316 Lisbon,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Cuf porto Porto,
Hospital Del Mar Barcelona,
Hospital Universitari Vall d Hebron Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario 12 de Octubre Madrid, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Virgen de la Victoria Málaga, Boehringer Ingelheim - (espana@bitrialsupport.com)
Indiana University Indianapolis, Indiana
Infirmary Cancer Care Mobile, Alabama Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Japanese Foundation for Cancer Research Tokyo, Koto-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kindai University Hospital Sayama, Osaka Boehringer Ingelheim - (nippon@bitrialsupport.com)
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Leicester Royal Infirmary Leicester, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
LungenClinic Grosshansdorf GmbH Großhansdorf,
MHAT Heart and Brain Pleven,
MHAT UniHospital Panagyurishte,
Mayo Clinic Cancer Center Jacksonville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mayo Clinic, Rochester Rochester, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mayo Clinic-Arizona Phoenix, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Montefiore Medical Center The Bronx, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
NCKUH Tainan,
National Cancer Center Hospital ChuoKu, Tokyo Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Cancer Center Hospital East Chiba, Kashiwa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osaka International Cancer Institute Osaka, Osaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Qilu Hospital, Shangdong University Jinan, Boehringer Ingelheim - (china@bitrialsupport.com)
Samsung Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Sendai Kousei Hospital Miyagi,
Severance Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai Chest Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Taipei Veterans General Hospital Taipei, Beitou District / R.o.c.
The Christie Manchester, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
UZ Leuven Leuven, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitair Ziekenhuis Gent Ghent, Boehringer Ingelheim - (belgique@bitrialsupport.com)
University College Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
University of California San Francisco San Francisco, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kansas Cancer Center Kansas City, Kansas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kentucky Medical Center Lexington, Kentucky Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Maryland School of Medicine Baltimore, Maryland Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Miami Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Universitätsklinikum Carl Gustav Carus Dresden Dresden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Erlangen Erlangen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Valkyrie Clinical Trials Los Angeles, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Virginia Commonwealth University Health- Adult Outpatient Pavilion Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
West China Hospital of Sichuan University Chengdu, Boehringer Ingelheim - (china@bitrialsupport.com)

ALS/MND Natural History Study Data Repository

Natalia Tarasenko - ntarasenko@mgh.harvard.edu

NCT05966038
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Inclusion Criteria:
* A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or * Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
Exclusion Criteria:
* Disease does not meet criteria for any motor neuron disorder
ALS, PLS, MND (Motor Neurone DIsease), Kennedy Disease, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy
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Study Locations

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Location Contacts
Centro Clinico NEMO Milano Milan, Monica Montuori - (monica.montuori@centrocliniconemo.it)
Hadassah Medical Organization Jerusalem, Michal Zabari - (michalza@hadassah.org.il)
Henry Ford Health System Detroit, Michigan Anne Vallis - (avallis1@hfhs.org)
Istituti Clinici Scientifici Maugeri SpA Milan, Camilla Garrè - (camilla.garre@icsmaugeri.it)
Kaiser Permanente Fresno, California Chris Greer - (chris.x.lindgren@kp.org)
Lahey Clinic Burlington, Massachusetts Sorieba Fofanah - (Sorieba.Fofanah@lahey.org) Melo Catia - (catia.s.melo@lahey.org)
Loma Linda University Health Loma Linda, California
Northwestern University Chicago, Illinois Emma Schmidt - (emma.schmidt@northwestern.edu)
Providence ALS Clinic Portland, Oregon Tyler Regan - (tyler.regan@providence.org)
Saint Louis University St Louis, Missouri Katie Forsman - (katie.forsman@health.slu.edu)
Tel Aviv Medical Center Tel Aviv, Beatrice Abramovich - (beatricen@tlvmc.gov.il)
Temple University Lewis Katz School of Medicine Philadelphia, Pennsylvania John Furey - (john.furey0001@temple.edu)
University of Florida Gainesville, Florida Jennifer Steshyn - (Jennifer.Steshyn@neurology.ufl.edu)
University of Minnesota Minneapolis, Minnesota Valerie Ferment - (ferm0016@umn.edu)
University of Pittsburgh Pittsburgh, Pennsylvania Helen Ismail - (ismailhh@upmc.edu)
Virginia Commonwealth University Richmond, Virginia Demetrius Carter - (Demetrius.R.Carter@vcuhealth.org)

Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

ctrrecruit@vcu.edu

NCT06500455
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Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: * Non-small cell lung cancer * Melanoma * Breast cancer * Renal cell carcinoma * Gastrointestinal cancer * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, etc.) is required * Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration * At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm * All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension * Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator * Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5 * No more than 2 lesions planned for resection if clinically indicated * No known leptomeningeal disease (LMD) * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion * Age ≥ 18 years * Karnofsky performance status (KPS) ≥ 60 * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\]) * New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) * No active infection currently requiring intravenous (IV) antibiotic management * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
PROCEDURE: Computed Tomography, RADIATION: Fractionated Stereotactic Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, RADIATION: Stereotactic Radiosurgery
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
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Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Regional Cancer Center Wausau, Wisconsin
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Boca Raton Regional Hospital Boca Raton, Florida
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (Roster@nrgoncology.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Castle Medical Center Kailua, Hawaii
Cedars Sinai Medical Center Los Angeles, California
Central Maryland Radiation Oncology in Howard County Columbia, Maryland
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chambersburg Hospital Chambersburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
City of Hope Antelope Valley Lancaster, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Corona Corona, California Site Public Contact - (becomingapatient@coh.org)
City of Hope South Bay Torrance, California
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Edward Hospital/Cancer Center Naperville, Illinois
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Goshen Center for Cancer Care Goshen, Indiana Site Public Contact - (cccois@goshenhealth.com)
Grady Memorial Hospital Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hartford Hospital Hartford, Connecticut
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Jersey Shore Medical Center Neptune City, New Jersey
John Muir Medical Center-Walnut Creek Walnut Creek, California Site Public Contact - (clinicalresearch@johnmuirhealth.com)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kettering Medical Center Kettering, Ohio
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington Site Public Contact - (oncologyresearch@lhs.org)
Legacy Good Samaritan Hospital and Medical Center Portland, Oregon Site Public Contact - (cancer@lhs.org)
Legacy Meridian Park Hospital Tualatin, Oregon
Legacy Mount Hood Medical Center Gresham, Oregon
Legacy Salmon Creek Hospital Vancouver, Washington
Loyola University Medical Center Maywood, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MaineHealth Cancer Care Center of York County Sanford, Maine
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Mary Greeley Medical Center Ames, Iowa
Maryland Proton Treatment Center Baltimore, Maryland Site Public Contact - (info@mdproton.com)
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Memorial Hermann Texas Medical Center Houston, Texas
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Hospital Springfield Springfield, Missouri
Miami Cancer Institute Miami, Florida
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NRG Oncology Philadelphia, Pennsylvania Rupesh R. Kotecha - (rupeshk@baptisthealth.net)
NYU Langone Hospital - Brooklyn Brooklyn, New York Site Public Contact - (david.wallach@nyulangone.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Northeast Radiation Oncology Center Dunmore, Pennsylvania
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Owensboro Health Mitchell Memorial Cancer Center Owensboro, Kentucky Site Public Contact - (vanissa.sorrels@owensborohealth.org)
Pamela Youde Nethersole Eastern Hospital Hong Kong,
Parkland Health Center - Farmington Farmington, Missouri
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Piedmont Hospital Atlanta, Georgia Site Public Contact - (ORS@piedmont.org)
Poudre Valley Hospital Fort Collins, Colorado
Providence Medical Foundation - Santa Rosa Santa Rosa, California
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Queen of The Valley Napa, California
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Medical Center Honolulu, Hawaii
Reading Hospital West Reading, Pennsylvania
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Rush MD Anderson Cancer Center Chicago, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SUNY Upstate Medical Center-Community Campus Syracuse, New York
Saint Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
Saint Elizabeth Youngstown Hospital Youngstown, Ohio
Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania
Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
The Community Hospital Munster, Indiana
The Hospital of Central Connecticut New Britain, Connecticut
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii Site Public Contact - (rohta@queens.org)
The Research Institute of the McGill University Health Centre (MUHC) Montreal, Quebec Site Public Contact - (evelyn.ortega@muhc.mcgill.ca)
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
The Valley Hospital - Luckow Pavilion Paramus, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UC San Diego Health System - Encinitas Encinitas, California
UC San Diego Medical Center - Hillcrest San Diego, California Site Public Contact - (rhabbaba@health.ucsd.edu)
UC San Diego Moores Cancer Center La Jolla, California Site Public Contact - (cancercto@ucsd.edu)
UCHealth Greeley Hospital Greeley, Colorado Site Public Contact - (Roster@nrgoncology.org)
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UCHealth University of Colorado Hospital Aurora, Colorado
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
UM Capital Region Medical Center Largo, Maryland Site Public Contact - (Sarah.Larson@umm.edu)
UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida Site Public Contact - (kginnity@med.miami.edu)
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UM Upper Chesapeake Medical Center Bel Air, Maryland
UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania
UPMC-Shadyside Hospital Pittsburgh, Pennsylvania
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Chicago Medicine-Orland Park Orland Park, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Hawaii Cancer Center Honolulu, Hawaii
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center-Overland Park Overland Park, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland Shore Medical Center at Easton Easton, Maryland Site Public Contact - (Christina.weisenborn@umm.edu)
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont Medical Center Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Health System Ridgewood Campus Ridgewood, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
WellSpan Health-York Cancer Center York, Pennsylvania
WellSpan Health-York Hospital York, Pennsylvania
WellStar Cobb Hospital Austell, Georgia Site Public Contact - (research@wellstar.org)
Wellstar Kennestone Hospital Marietta, Georgia Site Public Contact - (research@wellstar.org)
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii
William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland
Women's Diagnostic Center - Munster Munster, Indiana Site Public Contact - (mnicholson@comhs.org)