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482 Study Matches

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

Edwards TMTT Clinical Affairs - TMTT_Clinical@edwards.com

Gertz, Zachary
NCT04097145
HM20023593
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Inclusion Criteria:
* Eighteen (18) years of age or older * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. * Severe or greater tricuspid regurgitation * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months * Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
Exclusion Criteria:
* Tricuspid valve anatomy not evaluable by TTE or TEE * Tricuspid valve anatomy precludes proper device deployment and function * Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure) * Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
• Would prevent proper TR reduction due to interaction of the lead with the leaflets
• Were implanted in the RV within the last 90 days prior to the point of enrollment * Primary non-degenerative tricuspid disease * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days * Recent Stroke * Active gastrointestinal (GI) bleeding * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * Any of the following cardiovascular procedures:
• Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
• Carotid surgery within 30 days prior to the point of enrollment
• Direct current cardioversion within the last 30 days prior to the point of enrollment
• Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
• Cardiac surgery within 90 days prior to the point of enrollment * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days * Patient is oxygen-dependent or requires continuous home oxygen * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug, or device clinical study * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable
DEVICE: Edwards PASCAL System, DRUG: Optimal Medical Therapy, DEVICE: Edwards PASCAL System, DEVICE: Edwards PASCAL System
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
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Study Locations

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Location Contacts
Ascension St. Vincent Heart Center Cardiovascular Research Institute Indianapolis, Indiana
Banner University Medical Center Phoenix Phoenix, Arizona
Baylor College of Medicine St. Luke's Medical Center Houston, Texas
Baylor Scott & White - The Heart Hospital - Plano Plano, Texas
Carilion Medical Center Roanoke, Virginia
Cedars Sinai Medical Center Los Angeles, California
Columbia University Irving Medical Center/NYPH New York, New York
Cooper Health Systems Camden, New Jersey
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital Atlanta, Georgia
Erlanger Health System Chattanooga, Tennessee
Fairview Health Services Maplewood, Minnesota
HCA Houston Healthcare Medical Center Houston, Texas
Hamilton Health Services Hamilton, Ontario
Henry Ford Hospital Detroit, Michigan
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Québec, Quebec
Integris Baptist Medical Center Oklahoma City, Oklahoma
Intermountain Medical Center Murray, Utah
Johns Hopkins Baltimore, Maryland
Kaiser Permanente San Francisco San Francisco, California
Lankenau Heart Institute Wynnewood, Pennsylvania
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset New York, New York
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital The Bronx, New York
Morristown Medical Center Morristown, New Jersey
Mount Sinai Medical Center Miami Beach, Florida
NCH Healthcare System Naples, Florida
Northwestern University Chicago, Illinois
Ochsner Medical Center New Orleans, Louisiana
Oklahoma Cardiovascular Research Group Oklahoma City, Oklahoma
Oklahoma Heart Institute at Hillcrest Medical Center Tulsa, Oklahoma
Oregon Health & Science University Portland, Oregon
Penn State Hershey Hershey, Pennsylvania
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Piedmont Healthcare, Inc. Atlanta, Georgia
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle Wormleysburg, Pennsylvania
Providence St. Patrick Hospital Missoula, Montana
Rochester General Hospital Rochester, New York
Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey
SCPMG - Kaiser San Diego La Jolla, California
Saint Luke's Hospital of Kansas City Kansas City, Missouri
Sanford Medical Center Fargo Fargo, North Dakota
Sarasota Memorial Health Care System Sarasota, Florida
St. Francis Hospital Roslyn, New York
St. George Regional Hospital St. George, Utah
St. Joseph Hospital Bethpage, New York
St. Mary's of Ascension Research Saginaw, Michigan
St. Michael's Hospital Toronto, Ontario
St. Paul's Hospital Vancouver, British Columbia
Stanford University Redwood City, California
State University Of New York at Buffalo Buffalo, New York
Sunnybrook Health Sciences Centre Toronto, Ontario
Swedish Medical Center Englewood, Colorado
Tallahassee Research Institute Tallahassee, Florida
The Cardiac and Vascular Institute Research Foundation Gainesville, Florida
The Christ Hospital Cincinnati, Ohio
The Ohio State University Columbus, Ohio
The University of Texas Health Science Center at Houston Houston, Texas
TriHealth-Bethesda North Hospital Cincinnati, Ohio
Tucson Medical Center HealthCare Tucson, Arizona
UCLA Medical Center Los Angeles, California
UTHealth/Memorial Hermann Hospital Houston, Texas
University of California, Irvine Irvine, California
University of California, San Francisco San Francisco, California
University of Iowa Hospitals & Clinics Iowa City, Iowa
University of Michigan Ann Arbor, Michigan
University of North Carolina Chapel Hill, North Carolina
University of Ottawa Heart Institute Ottawa, Ontario
University of Virginia Health System Charlottesville, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia
Virginia Mason Medical Center Seattle, Washington
Washington University School of Medicine St Louis, Missouri
Weill Cornell Medicine New York, New York
William Beaumont Hospital - Royal Oak Royal Oak, Michigan

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)

Claudia M Amatruda, PhD - amatruda@xspline.com

NCT05327062
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Eligible subjects shall meet all following criteria:
• Appropriately signed and dated informed consent.
• Age ≥18 years at time of consent.
• CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
• Sinus rhythm
• QRS duration ≥130 ms
• Left bundle branch block
• Left ventricular ejection fraction ≤35%
• Symptomatic heart failure NYHA class ≥ II
• Documented stable medical treatment for at least 6 months
• No cardiovascular intervention during the last 6 month Exclusion Criteria are:
• History of persistent or permanent atrial fibrillation
• Previous pacemaker or ICD implantation
• Indication to pacing due to bradycardia
• Patients considered for His bundle pacing or cardiac conduction pacing
• Patients with unstable angina
• Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
• Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment
• Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
• Subject is implanted with a left ventricular assist device
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
• Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
• Subject has congenital heart disease
• Subject has a mechanical right-sided heart valve
• Subject has a life expectancy of less than one year in the opinion of the investigator
• Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the results of this study
• Patients who have contraindications to CT scanning.
• Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2
Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
Non-invasive activation mapping, Coronary Sinus
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Study Locations

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Location Contacts
Amsterdam University Medical Center Amsterdam, Reinoud Knops - (r.e.knops@amsterdamumc.nl)
Duke University Hospital Durham, North Carolina Daniel Friedman - (daniel.friedman@duke.edu)
General Hospital of Bolzano Bolzano, Rainer Oberhollenzer - (rainer.oberhollenzer@sabes.it)
Istituto Cardiocentro Ticino Lugano, Tessin Angelo Auricchio - (angelo.auricchio@eoc.ch)
King's College Hospital London, Aldo Rinaldi - (aldo.rinaldi@kcl.ac.uk)
Maastricht University Medical Center Maastricht, Kevin Vernooy - (kevin.vernooy@mumc.nl)
Massachusetts General Hospital Boston, Massachusetts Jag Singh - (JSINGH@mgh.harvard.edu)
Ordensklinikum Linz Elisabethinen Hospital Linz, Helmut Puererfellner - (helmut.puererfellner@ordensklinikum.at)
Policlinico Casilino Rome, Leonardo Calò - (leonardo.calo@icloud.com)
Queen Elizabeth Hospital Kota Kinabalu, Francisco Leyva - (cardiologists@hotmail.com)
Rush University Medical Center Chicago, Illinois Parikshit S Sharma - (parikshit_S_Sharma@rush.edu)
Semmelweis University Budapest, Bela Merkely - (merkely.bela@gmail.com)
The University of Chicago Medicine Chicago, Illinois Gaurav Upadhyay - (gupadhyay@medicine.bsd.uchicago.edu)
UKSH Universitätsklinikum Schleswig-Holstein Kiel, Thomas Demming - (thomas.demming@uksh.de)
Univeristat de Barcelona Barcelona, Lluis Mont - (lmont@clinic.cat)
Virginia Commonwealth University School of Medicine Richmond, Virginia Kenneth Ellenbogen - (kenneth.ellenbogen@vcuhealth.org)

Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)

Vinay Nadkarni, MD, MS - nadkarni@chop.edu

NCT02708134
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Inclusion Criteria:
* Patient received chest compressions for at least 1 minute * Patient between gestational age ≥37 weeks and 18 years of age
Exclusion Criteria:
* Patient on veno-arterial extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event
Cardiac Arrest, Cardiopulmonary Arrest
Chest compressions, Cardiopulmonary Resuscitation, Pediatric
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Study Locations

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Aichi Children's Health and Medical Center Ōbu,
Akron Children's Akron, Ohio
Albany Medical Center Albany, New York
Alberta Children's Calgary,
All Children's Hospital St. Petersburg, Florida
BC Children's Vancouver, British Columbia
Boston Children's Boston, Massachusetts
Cedars-Sinai Medical Center Los Angeles, California
Children's Colorado Aurora, Colorado
Children's Healthcare of Atlanta (CHOA) Atlanta, Georgia
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Vinay Nadkarni, MD, MS - (nadkarni@chop.edu)
Children's Hospital of Richmond at VCU Richmond, Virginia
Chldren's Hospital of Orange County Orange, California
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cohen Children's Medical Center Queens, New York
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire
Dell Children's Medical Center Austin, Texas
Erasmus MC - Sophia Children's Rotterdam,
Great Ormond Street Hospital London,
Gregorio Marañón General University Hospital Madrid,
IRCCS Ospedale Pediatrico Bambino Gesu Rome,
Instituto Roosevelt Bogotá,
KK Women's & Children's Hospital Singapore,
Kaiser Permanente Fresno, California
Kentucky Children's Hospital Lexington, Kentucky
King Chulalongkorn University Bangkok,
Kobe Children's Hospital (Hyogo Prefectural) Kobe,
Lurie Children's (Children's Hospital of Chicago) Chicago, Illinois
Massachusetts General Hospital Boston, Massachusetts
Medical City Children's Hospital Dallas, Texas
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Morgan Stanley Children's Hospital New York, New York
Mount Sinai Kravis Children's Hospital New York, New York
National Taiwan University Hospital Taipei,
National University Hospital Singapore,
Nationwide Children's Hospital Columbus, Ohio
Nebraska Medical Center Omaha, Nebraska
Nemours Children's Hospital Orlando, Florida
Perth Children's Hospital Perth, Western Australia
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital San Diego, California
Riley Hospital for Children Indianapolis, Indiana
Sabara Hospital Infantil São Paulo,
Seattle Children's Hospital Seattle, Washington
Seoul National University Bundang Hospital Seongnam,
St. Louis Children's Hospital St Louis, Missouri
Stanford University Redwood City, California
Starship Children's Hospital Grafton, Auckland
Stollery Children's Hospital Edmonton, Alberta
Stony Brook University Hospital Stony Brook, New York
The Children's Hospital at Westmead Westmead, New South Wales
The Children's Hospital of San Antonio San Antonio, Texas
The Johns Hopkins Hospital Baltimore, Maryland
Tokyo Metropolitan Children's Medical Center Tokyo,
University of Chicago, Comer Children's Hospital Chicago, Illinois
University of Iowa Stead Family Children's Hospital Iowa City, Iowa
University of North Carolina Chapel Hill, North Carolina
University of Texas Southwestern Dallas, Texas
Upstate Golisano Children's Hospital Syracuse, New York
Valley Children's Hospital Madera, California

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Boomer, Laura, A
NCT05235165
HM20024392
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment. * Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size. * Note: Patient must have eligibility confirmed by rapid central imaging review. * Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon. * Patients must have a histological diagnosis of osteosarcoma. * Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease. * Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery. * Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation. * Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor. * Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi). * Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion. * Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team. * Patients with evidence of extrapulmonary metastatic disease. * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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Study Locations

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Location Contacts
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Ann M Wierman MD LTD Las Vegas, Nevada
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
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)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.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)
C S Mott Children's Hospital Ann Arbor, Michigan
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital at Montefiore The Bronx, New York Site Public Contact - (aaraiza@montefiore.org)
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
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)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, 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)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
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)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
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-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
King Faisal Specialist Hospital and Research Centre Riyadh,
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
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)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Nicklaus Children's Hospital Miami, Florida
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
Northern Nevada Radiation Oncology Reno, Nevada
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Radiation Oncology Associates Reno, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Royal Children's Hospital Parkville, Victoria
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical 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)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Michigan Rogel Cancer Center Ann Arbor, Michigan Site Public Contact - (CancerAnswerLine@med.umich.edu)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Site Public Contact - (ctsucontact@westat.com)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

Marco Carini, Prof. - carini@unifi.it

NCT05363657
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Inclusion Criteria:

• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
• Age ?18 years
• Informed consent signed
Exclusion Criteria:

• Patient refuse to participate in clinical research.
• Urothelial renal carcinoma.
Procedure: Partial Nephrectomy (PN), Procedure: Radical Nephrectomy (RN), Procedure: Ablation therapy (AT), Diagnostic Test: Active Surveillance (AS)
Kidney Cancer
Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
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AOUI Verona Verona, Vr Alessandro Antonelli - (alessandro.antonelli@me.com)
Amsterdam University Medical Centers Amsterdam, Axel Bex - (a.bex@nki.nl)
Azienda Ospedaliera Policlinico "G. Martino", Universit? di Messina. Messina, Vincenzo Ficarra - (vficarra@unime.it)
Bristol Urological Institute Bristol, Francis Keeley - (Francis.Keeley@nbt.nhs.uk)
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital Firenze, Andrea Mari - (andrea.mari@unifi.it)
Division of Urology, University of Genoa,Policlinico San Martino Hospital Genova, Carlo Terrone - (carlo.terrone@med.uniupo.it)
European Health Center Otwock, Lukasz Nyk - (ukinyk@poczta.fm) Hubert Kamecki - (hubert@kamecki.pl)
Fundaci? Puigvert Barcelona, Joan Palou - (ipalou@fundacio-puigvert.es)
Guy's Hospital London, Ben Challacombe - (benchallacombe@doctors.org.uk)
Hospital Universitario Ram?n y Cajal, University of Alcal Madrid, Vital Hevia - (vital.hevia.uro@gmail.com)
Humanitas Hospital Rozzano, Nicolomaria Buffi - (nicolo.buffi@hunimed.eu)
Institute Oncology Veneto (IOV) Padova, Angelo Porreca - (angeloporreca@gmail.com)
Institute of Urology, University of Southern California. Los Angeles, California Giovanni E Cacciamani - (giovanni.cacciamani@med.usc.edu)
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale" Napoli, Sisto Perdona' - (s.perdona@istitutotumori.na.it)
Jikei University School of Medicine Minato-ku, Tokyo, Shin Egawa - (s-egpro@jikei.ac.jp)
Loyola University Medical Center, Edward Hines VA Hospital Chicago, Illinois Gopal Gupta - (GOGUPTA@lumc.edu)
Medical University of Vienna, Vienna General Hospital Vienna, Shahkrokh F Shariat - (shahrokh.shariat@meduniwien.ac.at)
N.N. Blokhin National Medical Research Center of Oncology Moscow, Vsevolod Matveev - (vsevolodmatveev@mail.ru)
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Warsaw, Roman Sosnowski - (roman.sosnowski@gmail.com)
Ng Teng Fong General Hospital Singapore, Vineet Gaauhaar - (vineetgaauhaar@gmail.com)
Onze Lieve Vrouw Hospital Leuven, Geert De Naeyer - (geertdenaeyer@yahoo.com)
Policlinico Istituto Europeo di Oncologia (IEO) Milano, Ottavio De Cobelli - (Ottavio.DeCobelli@ieo.it)
Policlinico Riuniti, Universit? di Foggia. Foggia, Giuseppe Carrieri - (giuseppe.carrieri@unifg.it) Gian Maria Busetto - (gianmaria.busetto@unifg.it)
Policlinico S. Orsola Malpighi Bologna, Riccardo Schiavina - (rschiavina@yahoo.it)
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital Milano, Umberto Capitanio - (umbertocapitanio@gmail.com)
Santa Casa da Miseric?rdia de Fortaleza Fortaleza, Francisco Hidelbrando A Mota Filho - (fha.motafilho@gmail.com)
Stanford University Redwood City, California Benjamin I Chung - (bichung@stanford.edu)
Swedish Hospital Seattle, Washington James Porter - (porter@swedishurology.com)
Universit? degli Studi di Torino, Ospedale S. Luigi Gonzaga. Torino, Francesco Porpiglia - (porpiglia@libero.it)
Universit? degli studi di Torino, Ospedale Molinette Torino, Paolo Gontero - (paolo.gontero@unito.it)
University Hospitals Leuven Leuven, Maarten Albersen - (maarten.albersen@uzleuven.be)
University of Bruxelles Bruxelles, Simone Albisinni - (albisinni.simone@gmail.com)
University of California San Diego, Moores Cancer Center San Diego, California Ithaar Derweesh - (iderweesh@gmail.com)
University of Patras Patras, Evangelos Liatsikos - (liatsikos@yahoo.com)
University of Pennsylvania Philadelphia, Pennsylvania Philip Pierorazio - (Phillip.Pierorazio@pennmedicine.upenn.edu)
Urology, Andrology & Kidney Transplantation Unit, University of Bari Bari, Pasquale Ditonno - (pasquale.ditonno@uniba.it)
VCU Health System Richmond, Virginia Riccardo Autorino - (ricautor@gmail.com)

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Iovance Biotherapeutics Study Team lungcelltherapy.com - Clinical.Inquiries@iovance.com

Poklepovic, Andrew, S
NCT04614103
HM20023194
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Inclusion Criteria:
* Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor. * Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations. * For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required. * Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines. * LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression * Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy. * At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1 * Have adequate organ function * LVEF \> 45%, NYHA Class 1 * Have adequate pulmonary function * ECOG performance status of 0 or 1 * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
Exclusion Criteria:
* Patients who have EGFR, ALK or ROS1 driver mutations * Patients who have symptomatic, untreated brain metastases. * Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years * Patients who have any form of primary immunodeficiency * Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment * Patients who have had another primary malignancy within the previous 3 years * Participation in another interventional clinical study within 21 days
BIOLOGICAL: LN-145, BIOLOGICAL: LN-145
Metastatic Non Small Cell Lung Cancer
LN-145, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Non Small Cell Lung Cancer, NSCLC, Second line Lung Cancer, Bronchial Neoplasms, Carcinoma, Lung Disease, Metastatic Lung Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic NSCLC, Lung Carcinoma, PD-L1, Stage IV Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV NSCLC, Systemic Therapy, 2nd line therapy, Second line therapy, CPI, Immune checkpoint inhibitor (ICI), NSCLC Recurrent, Recurrent Lung Cancer, Recurrent Lung Carcinoma
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Study Locations

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Advocate Aurora Health Park Ridge, Illinois
Allegheny General Hospital Pittsburgh, Pennsylvania
Avera Medical Group Cancer Institute Sioux Falls, South Dakota
Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro,
Azienda Ospedaliera Universitaria Careggi Florence,
Banner Health MD Anderson Gilbert, Arizona
Baptist Cancer Center Memphis, Tennessee
C.H. Regional Reina Sofia Córdoba,
CHRU de Poitiers La Miletrie Poitiers,
CHU Nantes Nantes,
CHU Nice Nice,
Centre Hospitalier Lyon Sud Pierre-Bénite,
Centre Hospitalier Universitaire Vaudois Lausanne Lausanne, Canton of Vaud
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Charite- Universitätsklinikum Berlin Berlin,
Clinical Universitaria de Navarra Pamplona,
Consorcio Hospital General Universitario de Valencia Valencia,
Fondazione IRCCS Policlinico San Matteo di Pavia Pavia,
Gachon Unversity Gil Medical Center Incheon,
Gustave Roussy Cancer Campus Villejuif,
Guy's Hospital London,
H Lee Moffitt Cancer Center and Research Institute Tampa, Florida
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Amsterdam,
Hollywood Private Hospital Ramsay Nedlands, Western Australia
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Regional Universitario de Malaga Málaga,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario A Coruna A Coruña,
Hospital Universitario La Paz Madrid,
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal Madrid,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Salamanca Salamanca,
IRCCS Fondazione del Piemonte per l'Oncologia Piemonte,
Institut Paoli Calmettes Marseille,
Instituto Oncologico Rosell Barcelona,
Karmanos Cancer Institute Detroit, Michigan
MD Anderson Cooper Camden, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
National Cancer Centre Singapore Singapore,
New York University Langone Medical Center New York, New York
Novant Health - Winston-Salem Winston-Salem, North Carolina
Ohio State University Comprehensive Cancer Center Columbus, Ohio
Oregon Health and Science University Portland, Oregon
Queen Elizabeth Hospital Birmingham Edgbaston, Birmingham,
Royal Marsden Hospital London,
Rush University Medical Center Chicago, Illinois
Samsung Medical Center Seoul,
Sanford Cancer Center Sioux Falls, South Dakota
Sanford Roger Maris Cancer Center Fargo, North Dakota
Sarah Cannon Research Institute Nashville, Tennessee
Seattle Cancer Care Alliance Seattle, Washington
Severance Hospital, Yonsei University Seoul,
St. Vincent's Hospital Darlinghurst, New South Wales
Sylvester Comprehensive Cancer Center Plantation, Florida
The Christie NHS Foundation Trust Manchester,
Universitatsklinikum Mannheim Mannheim,
University College London London,
University of Cincinnati Medical Center Cincinnati, Ohio
University of Illinois Hospital & Health Sciences System Chicago, Illinois
University of Louisville Louisville, Kentucky
University of Maryland Baltimore, Maryland
University of Minnesota Minneota, Minnesota
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina Chapel Hill, North Carolina
University of Tennessee Medical Center Knoxville, Tennessee
Universitätsklinikum Carl Gustav Carus, MK I Dresden,
Universitätsklinikum Frankfurt Frankfurt am Main,
VCU Medical Center (Virginia Commonwealth University) Richmond, Virginia
Westmead Hospital Westmead,

Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

Sherry Boyett, RN - sherry.boyett@vcuhealth.org

NCT05424003
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Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.) * Liver transplant surgery within 8-24 weeks prior to randomization * Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%) * Ability to provide informed consent * Discharged from the hospital following LT surgery * Tolerating diet * Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel) * Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate) * Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study
Exclusion Criteria:
* BMI≤ 27kg/m2 * GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2 * Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis) * History of gastroparesis * Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2 * History of pancreatitis * History of active malignancy post- LT with the exception of non-melanoma skin cancers * History of uncontrolled or unstable diabetic retinopathy or maculopathy * Acute cellular rejection * Hepatic artery thrombosis * Medical non-compliance * Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening * History of hypersensitivity to semaglutide or its excipients * Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures
DRUG: Semaglutide Pen Injector, DRUG: Placebo
NAFLD
Liver Transplant
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Virginia Commonwealth University Richmond, Virginia

Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)

Ashraf Gorgey, MPT, PhD, FACSM, FACRM - Ashraf.Gorgey@va.gov

NCT05423600
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Inclusion Criteria:

• A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
• Participants must have a companion that will be able to help him/her throughout the study.
• Greater than 1-year post SCI, neurologic level of C8 or above.
• American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
• Visible muscle contraction response to NMES wrist extensors, bilaterally.
• Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
• Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion Criteria:

• Unhealed fracture in upper or lower extremities.
• Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
• High resting blood pressure greater than 140/80 mmHg.
• Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
• Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
• Implanted pacemakers and/or implanted defibrillator devices.
• Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• Other exclusion criteria at the discretion of the medical team may include:
• Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
• Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
• Unresolved deep vein thrombosis.
• Psychiatric or cognitive impairments that preclude adherence to the intervention.
• Known cardiac pathology that precludes safe participation.
• Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
• Presence of pressure sores stage three or greater.
• Presence of a symptomatic urinary tract infection.
• Severe spasticity as assessed by the Modified Ashworth Scale.
• Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
PROCEDURE: BES + TS, PROCEDURE: Experimental: BES+sham TS
Tetraplegia/Tetraparesis
Spinal Cord Injury
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Richmond VA Medical Center Richmond, Virginia
Sheltering Arms Physical Rehabilitation Centers Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia

Children's Bipolar Network Treatment Trial I (CBN)

David J Miklowitz, PhD - dmiklowitz@mednet.ucla.edu

NCT05427123
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Inclusion Criteria:
* Youth 9-19 years old * Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening * Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up * Youth has a caregiver able to participate in ongoing basis in assessment and treatment * The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion Criteria:
* Youth has DSM-5 diagnosis of autism spectrum disorder * Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos. * Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment * Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers * Evidence of recent intimate partner violence between caregivers responsible for the youth's care
OTHER: Medication or psychosocial treatment
Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder, Adolescent - Emotional Problem
medication, psychosocial, treatment, longitudinal, naturalistic, assessment
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University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) Los Angeles, California David J Miklowitz, PhD - (dmiklowitz@mednet.ucla.edu) Megan C Ichinose, PhD - (michinose@mednet.ucla.edu)
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center Aurora, Colorado
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) Pittsburgh, Pennsylvania
Virginia Commonwealth University Medical Center Richmond, Virginia

GiST (GiST)

Vences, Karina - venceskm@vcu.edu

Goldman, Myla
NOT REQUIRED
HM20022775
Diseases of Nervous System and Sense Organs (320-389)
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Virginia Commonwealth University Richmond, Virginia Vences, Karina - (venceskm@vcu.edu)

Uptake of NCI Research Tested Intervention Program to Increase CRC Screening in Rural Setting

Preston, Michael - prestonm2@vcu.edu

Preston, Michael
16928
HM20019703
Rectum, Colon
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Virginia Commonwealth University Richmond, Virginia Preston, Michael - (prestonm2@vcu.edu)

Community Outreach and Engagement Key Informant Interviews

Cummings, Yvonne - yvonne.cummings@vcuhealth.org

Sheppard, Vanessa, B.
15900
HM20018062
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Virginia Commonwealth University Richmond, Virginia Cummings, Yvonne - (yvonne.cummings@vcuhealth.org)

A Cognitive Task Analysis of Pediatric Hematology/Oncology Faculty

DiazGranados, Deborah - diazgranados@vcu.edu

Helou, Marieka, Ann
15801
HM20017417
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Virginia Commonwealth University Richmond, Virginia DiazGranados, Deborah - (diazgranados@vcu.edu)

CASTOR-2: Identifying Subclinical Cardiotoxicity Following RT for Locally Advanced Lung Cancer (CASTOR-2)

Kontos, Emily - kontosej@vcu.edu

Thomas, Georgia
15564
HM20017432
Lung
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Virginia Commonwealth University Richmond, Virginia Kontos, Emily - (kontosej@vcu.edu)

Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT

Roberts, Catherine, H. - croberts2@vcu.edu

Toor, Amir, A
15122
HM20016672
Other Hematopoietic
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Virginia Commonwealth University Richmond, Virginia Roberts, Catherine, H. - (croberts2@vcu.edu)

Biomarkers of Malignant and Non-Malignant Pleural Effusion

Narron, Kyle, A - Kyle.Narron@vcuhealth.org

Shojaee, Samira
15081
HM20012669
Any Site
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Virginia Commonwealth University Richmond, Virginia Narron, Kyle, A - (Kyle.Narron@vcuhealth.org)

Unpacking Multilevel Drivers of Cardiotoxicity Disparities in Breast Cancer Survivors

Sutton, Arnethea - abrahamal@vcu.edu

Sheppard, Vanessa, B.
16953
HM20019941
Breast
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Virginia Commonwealth University Richmond, Virginia Sutton, Arnethea - (abrahamal@vcu.edu)

Cognitive Support Technology for Postsecondary Students with Traumatic Brain Injuries

Getzel, Elizabeth, E - lgetzel@vcu.edu

Getzel, Elizabeth, E
17135
HM20019040
External Causes of Injury and Poisoning (800-999)
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Virginia Commonwealth University Richmond, Virginia Getzel, Elizabeth, E - (lgetzel@vcu.edu)

Prognostic Gene Expression Profiling and Adjuv Therapy in Stage IIB-C & IIIA-B Cutaneous Melanoma

Gnanasigamani Manogaram, Merlin Margaret - gnanasigamam@vcu.edu

Poklepovic, Andrew, S
17390
HM20021149
Melanoma, skin
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Virginia Commonwealth University Richmond, Virginia Gnanasigamani Manogaram, Merlin Margaret - (gnanasigamam@vcu.edu)

Feasibility, Acceptability, and Preliminary Effectiveness of the ICAN QUIT Tobacco Program at VCUH

Hunley, Rachel - rachel.hunley@vcuhealth.org

Hayes, Rashelle
17440
HM20020118
Any Site
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Virginia Commonwealth University Richmond, Virginia Hunley, Rachel - (rachel.hunley@vcuhealth.org)

Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)

ctrrecruit@vcu.edu

Breland, Alison
19170
HM20018580
Any Site
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Virginia Commonwealth University Richmond, Virginia

Longitudinal Survey and Behavior Assessment of Experienced E-cigarette Users (P4 @ VCU)

ctrrecruit@vcu.edu

Breland, Alison
19168
HM20018209
Any Site
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Virginia Commonwealth University Richmond, Virginia

Salad Bars in the National School Lunch Program

ctrrecruit@vcu.edu

Bean, Melanie, K.
19167
HM20012226
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Virginia Commonwealth University Richmond, Virginia

Predicting Effects of Tobacco Product Flavor Regs Among Black/African American Menthol Smokers

ctrrecruit@vcu.edu

Cobb, Caroline
19166
HM20022619
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Virginia Commonwealth University Richmond, Virginia

Effects of E-Cigarette Nicotine Delivery on Abuse Liability in Smokers

ctrrecruit@vcu.edu

Cobb, Caroline
19165
HM20018290
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Virginia Commonwealth University Richmond, Virginia

Massey Adult Community Cigar Study

ctrrecruit@vcu.edu

Cobb, Caroline
19162
HM20013308
Any Site
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Virginia Commonwealth University Richmond, Virginia

Noninvasive Assessment of Esophageal Varices in Patients with Unresectable Hepatocellular Carcinoma

ctrrecruit@vcu.edu

Wedd, Joel
19108
HM20023235
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Virginia Commonwealth University Richmond, Virginia

Pt QoL & Social Support after Cytoreductive Surgery & Hyperthermic Intraperitoneal Chemo

Freudenberger, Devon - devon.freudenberger@vcuhealth.org

Trevino, Jose
19045
HM20023396
Soft Tissue
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Virginia Commonwealth University Richmond, Virginia Freudenberger, Devon - (devon.freudenberger@vcuhealth.org)

Role of GABA in Motor Symptoms and Neurophysiological Abnormalities in Dystonia

Crump, Elizabeth - crumpeg@vcu.edu

Berman, Brian
18815
HM20021040
Diseases of Nervous System and Sense Organs (320-389)
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Virginia Commonwealth University Richmond, Virginia Crump, Elizabeth - (crumpeg@vcu.edu)

Cancer Prevention for Virginia Firefighters

ctrrecruit@vcu.edu

Burch, James
18656
HM20022904
Any Site
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Virginia Commonwealth University Richmond, Virginia