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16 Study Matches
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
OHB Contact - CMO@Oakhillbio.com
Rozycki, Henry
NCT03253263
HM20016299
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Inclusion Criteria:
• Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
• Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
• Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
Exclusion Criteria:
• Detectable major (or severe) congenital malformation identified before randomization.
• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
• Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
• Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
• Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
• Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
• The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
• Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
• Birth mother with known HIV or hepatitis (B, C, or E) infection.
DRUG: OHB-607
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
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Study Locations
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| Location | Contacts |
|---|---|
| Academisch Medisch Centrum Amsterdam Amsterdam-Zuidoost, North Holland | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital Chertsey, Surrey | |
| Azienda Ospedaliera Di Padova Padua, | |
| Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale Florence, | |
| Boston Children's Hospital Boston, Massachusetts | |
| Centro Hospitalar Lisboa Lisbon, | |
| Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. Porto, | |
| Chelsea and Westminster NHS Trust London, | |
| Children's Hospital of Orange County Orange, California | |
| Children's Minnesota - Children's Hospital and Clinics Saint Paul, Minnesota | |
| Children's Minnesota - Children's Hospital and Clinics - St. Paul Saint Paul, Minnesota | |
| Cork University Maternity Hospital Cork, Wilton | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, MI | |
| Fondazione Policlinico Universitario A Gemelli Rome, Lazio | |
| Groupe Hospitalier Necker Enfants Malades Paris, | |
| Hopital Antoine Beclere Clamart, Hauts-de-Seine | |
| Hospital Garcia de Orta Almada, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Genova, | |
| Jackson Memorial Hospital Miami, Florida | |
| Kagoshima City Hospital Kagoshima, Kagoshima-ken | |
| Karolinska Solna Stockholm, | |
| Klinikum Nürnberg Nuremberg, | |
| Kurashiki Central Hospital Kurashikishi, Okayama-ken | |
| LAC USC Medical Center Los Angeles, California | |
| Liverpool Women's Hospital - PPDS Liverpool, | |
| Maastricht University Medical Center Maastricht, Limburg | |
| Maria Fareri Children's Hospital Valhalla, New York | |
| Maternidade Alfredo da Costa Lisbon, | |
| Medical University of South Carolina Children Hospital Charleston, South Carolina | |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Mount Sinai Hospital New York, New York | |
| Nagano Children's Hospital Azumino, Nagano | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Norfolk and Norwich University Hospital Norwich, Norfolk | |
| Norton Children's Hospital Louisville, Kentucky | |
| Ochsner Baptist Medical Center New Orleans, Louisiana | |
| Osaka Women's and Children's Hospital Izumi, Ôsaka | |
| Oulun Yliopistollinen Sairaala Oulu, | |
| Presidio Ospedaliero Di Treviso Ca' Foncello Treviso, | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Sainte Justine Hospital Montreal, Quebec | |
| Saitama Medical Center Saitama, | |
| Skanes universitetssjukhus Lund, | |
| St. Mary's Hospital Manchester, | |
| Tampa General Hospital Tampa, Florida | |
| Tufts Medical Center Boston, Massachusetts | |
| UVA Children's Hospital Charlottesville, Virginia | |
| Universitatsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitatsklinikum Leipzig Leipzig, Saxony | |
| University College London London, | |
| University Hospital Coventry Coventry, | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Cambridge Cambridge, | |
| University of Illinois at Chicago Chicago, Illinois | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Rochester Rochester, New York | |
| Virginia Commonwealth University - Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Wilhelmina Children Hospital-University Medical Center Utrecht Utrecht, |
A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH) (ROAR)
Bayer Clinical Trials Contact - clinical-trials-contact@bayer.com
Grinnan, Daniel, C
NCT04813926
HM20022707
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Inclusion Criteria:
• Patients aged ≥18 years at the time of riociguat treatment initiation
• Diagnosis of PAH per National Institute for Health and Care Excellence (NICE) 2018 classification
• Decision to initiate treatment with riociguat as per investigator's routine treatment practice made prior to enrollment in the study
• Initiation of riociguat, as per the FDA-approved US label:
• At enrollment OR
• ≤90 days prior to enrollment, with a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)
• Signed informed consent
Exclusion Criteria:
• Previously treated with and discontinued use of riociguat for any reason prior to study enrollment (discontinuation defined as an interruption of therapy ≥30 days)
• Participating in any of the following:
• Blinded clinical trial
• Clinical trial involving an unapproved drug
• Investigational program with interventions outside of routine clinical practice
• Life expectancy <12 months
• Contraindicated to receive riociguat per the FDA approved US label
• Use of nitrates or NO donors in any form
• Use of PDE5 inhibitors
• PH associated with idiopathic interstitial pneumonias
• Unable or unwilling to provide informed consent
Drug: Riociguat (Adempas, BAY63-2521)
Pulmonary Arterial Hypertension
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Study Locations
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| Location | Contacts |
|---|---|
| Advent Health Orlando, Florida | |
| Advocate Aurora Milwaukee, Wisconsin | |
| Advocate Christ Oak Lawn, Illinois | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Alliance Pulmonary Guaynabo, | |
| AnMed Health Medical Center Anderson, South Carolina | |
| Banner University Medical Center- Phoenix Phoenix, Arizona | |
| Barnes / Wash U Saint Louis, Missouri | |
| Baylor Scott and White Dallas, Texas | |
| Beaumont Hospital Dublin, Co Dublin | |
| Boston University Boston, Massachusetts | |
| CCF (Cleveland Clinic Florida) Weston, Florida | |
| Cedar Sinai Los Angeles, California | |
| Columbia New York, New York | |
| Froedtert/Medical College of Wisconsin Milwaukee, Wisconsin | |
| Honor Health Scottsdale, Arizona | |
| Houston Methodist Houston, Texas | |
| INTEGRIS Oklahoma City, Oklahoma | |
| KUMC Kansas City, Kansas | |
| Legacy Health Portland, Oregon | |
| Loyola Maywood, Illinois | |
| Mass General Boston, Massachusetts | |
| Mount Sinai New York, New York | |
| NYU Langone New York, New York | |
| Northwell Health Manhasset, New York | |
| Northwestern Chicago, Illinois | |
| Norton Pulmonary Specialists Louisville, Kentucky | |
| Premier Pulmonary Denison, Texas | |
| Providence Spokane, Washington | |
| Richmond Pulmonary Associates Richmond, Virginia | |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Seton Heart Austin, Texas | |
| St Francis Medical Ctr Columbus, Georgia | |
| St. Louis University St Louis, Missouri | |
| Tampa General Hospital USF Tampa, Florida | |
| Temple University Philadelphia, Pennsylvania | |
| UC Davis Sacramento, California | |
| UC Irvine Orange, California | |
| UCSD San Diego, California | |
| UCSF San Francisco, California | |
| UNMC Omaha, Nebraska | |
| UNMH Albuquerque, New Mexico | |
| USC Los Angeles, California | |
| UT Southwestern Dallas, Texas | |
| Univ of Arizona College of Medicine, Tucson Tucson, Arizona | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Missouri Columbia, Missouri | |
| University of Rochester Rochester, New York | |
| VCU/MCV Richmond, Virginia | |
| Winthrop Mineola, New York |
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 | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| 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 | |
| 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 - (rryan@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) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 | |
| 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) |
| OptumCare Cancer Care at Seven Hills Henderson, 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 | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| 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) |
| 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 Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.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 Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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 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) |
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
Chaudary, Nauman
NCT05069597
HM20025086
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Inclusion Criteria:
• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.
Exclusion Criteria:
• Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Drug: CREON
Cystic Fibrosis, Chronic Pancreatitis
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
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Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical College-Pulmonary /ID# 250041 Albany, New York | |
| Asr, Llc /Id# 239566 Nampa, Idaho | |
| Atlantic Medical Research Group /ID# 239568 Margate, Florida | |
| Baylor College of Medicine Medical Center /ID# 233441 Houston, Texas | |
| Central FL Pulmonary Orlando /ID# 245863 Orlando, Florida | |
| Children's Hospital of Richmond at VCU /ID# 245988 Richmond, Virginia | |
| Cleveland Clinic Main Campus /ID# 245864 Cleveland, Ohio | |
| Dartmouth-Hitchcock Medical Center /ID# 231633 Lebanon, New Hampshire | |
| GI Pros /ID# 239486 Naples, Florida | |
| NYU Langone Health /ID# 233417 New York, New York | |
| Options Health Research, LLC /ID# 239535 Tulsa, Oklahoma | |
| The Curators of the University of Missouri /ID# 233331 Columbia, Missouri | |
| UH Cleveland Medical Center /ID# 246065 Cleveland, Ohio | |
| UMass Chan Medical School /ID# 230476 Worcester, Massachusetts | |
| Univ Texas HSC San Antonio /ID# 239060 San Antonio, Texas | |
| University of Cincinnati /ID# 229511 Cincinnati, Ohio | Site Coordinator |
| University of Florida - Archer /ID# 233411 Gainesville, Florida | |
| University of Miami, Miller School of Medicine /ID# 239415 Miami, Florida | |
| Valley Children's Hospital /ID# 231452 Madera, California | |
| Velocity Clinical Research /ID# 231076 Mobile, Alabama | Site Coordinator |
| Wake Forest Baptist Health /ID# 229537 Winston-Salem, North Carolina | |
| West Virginia University Hospitals /ID# 239593 Morgantown, West Virginia |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06003426
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Inclusion Criteria
* Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
* Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion Criteria
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Idiopathic Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
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Show 504 locations
Study Locations
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| Location | Contacts |
|---|---|
| "Corfu General Hospital ""St. IRINI""" Corfu, | |
| "General Hospital of Thessaloniki ""G. Papanikolaou""" Pylaia-Chortiatis, B | |
| "Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì, | |
| ACE Hospital & Research Center Pune, Maharashtra | |
| AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli, | |
| Aarhus University Hospital Aarhus N, | |
| Accellacare US Inc. of Wilmington Wilmington, North Carolina | |
| Ajou University Hospital Gyeonggi-do, | |
| All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi | |
| Alliance Pulmonary Group Guaynabo, PR | |
| Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam, | |
| AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina | |
| Anhui Medical University - Anhui Chest Hospital Hefei, AH | |
| Anhui Medical University - The Second Hospital - Hematological Research Center Hefei, Anhui | |
| Anhui Provincial Hospital Hefei City, Anhui Province, Anhui | |
| Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara, | |
| Asan Medical Center (AMC) Songpa-gu, Seoul | |
| Aso Iizuka Hospital Iizuka-shi, | |
| Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille, | |
| Asst Papa Giovanni XXIII Bergamo, | |
| Asthma Bhawan Jaipur, Rajasthan | |
| Athens Medical Center Marousi, Attica | |
| Avanza Medical Research Center Pensacola, Florida | |
| Azienda Ospedaliera San Paolo Milan, | |
| Azienda Ospedaliera Universitaria - Universita di Sassari Sassari, | |
| Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, AN | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine Houston, Texas | |
| Baylor University Medical Center at Dallas Dallas, Texas | |
| Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Beijing Friendship Hospital, Capital Medical University Beijing, BJ | |
| Bioreuma Concepción, Bio Bio | |
| Brightshores Health System Owen Sound, Ontario | |
| Burlington Lung Clinic Burlington, Ontario | |
| C.I.C. Joliette Saint-Charles-Borromée, Quebec | |
| C.I.C. Mauricie Inc. Trois-Rivières, Quebec | |
| CEC Centros Estudios Clinicos Santiago, RM | |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo, São Paulo | |
| CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso | |
| CHRU de Tours - Hôpital Bretonneau Tours, | |
| CHU Dijon - Hôpital François Mitterrand Dijon, | |
| CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac, | |
| CHU UCL Namur - Mont-Godinne Yvoir, Namur | |
| CHU de Brest - Hôpital Cavale Blanche Brest, | |
| CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region | |
| Carmel Medical Center Haifa, | |
| Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku, | |
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes | |
| Centre Hospitalier Universitaire d'Angers Angers, | |
| Centre Hospitalier Universitaire de Liege - Sart Tilman Liège, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centro Medico Santa Maria Barra Mansa, Rio de Janeiro | |
| Centro Medico de Enfermedades Respiratorias Florida, B | |
| Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B | |
| Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo | |
| Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca | |
| Centro de Investigacion Curico Curicó, Maule Region | |
| Centro de Investigaciones Metabólicas (CINME) Buenos Aires, | |
| Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán | |
| Centro de Investigación del Maule Talca, Maule Region | |
| Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship | |
| Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung | |
| Changhua Christian Hospital Changhua County, | |
| Chiba University Hospital Chiba, Chiba | |
| China Medical University Hospital Taichung, | |
| Christiana Care Pulmonary Associates - Newark Newark, Delaware | |
| Clinica 25 de Mayo Mar del Plata, B | |
| Clinica Providencia San Miguel, LIM | |
| Clinica Universidad de Navarra Madrid, | |
| Clinica Universidad de los Andes Santiago, RM | |
| Clinical Research Specialists, LLC - Kissimmee Kissimmee, Florida | |
| Cliniques Universitaires Saint-Luc Brussels, | |
| Clínica Universidad de Navarra -Madrid Madrid, | |
| Clínica de día Jockey Salud Lima, LIM | |
| Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida | |
| Connolly Hospital Blanchardstown Dublin, | |
| Consultorios Médicos del Buen Ayre Caba, B | |
| David Geffen School of Medicine at UCLA Los Angeles, California | |
| Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec | |
| Dokuz Eylul Universitesi Tip Fakultesi Pasaport, | |
| Duke University Medical Center Durham, North Carolina | |
| Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir, | |
| Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland | |
| Erciyes University School of Medicine Kayseri, | |
| Escola Paulista de Medicina São Paulo, | |
| Fachkrankenhaus Coswig GmbH Coswig, | |
| Far Eastern Memorial Hospital New Taipei City, | |
| Fiona Stanley Hospital Murdoch, | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, MI | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Fortis Hospital Mohali Mohali, Punjab | |
| Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires | |
| Fundacion Respirar Buenos Aires, B | |
| Fundacion Santa Fe de Bogota Bogotá, | |
| Fundacion Scherbovsky Mendoza, M | |
| Gachon University - Gil Medical Center Incheon, | |
| Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland | |
| Gentofte Hospital Hellerup, | |
| Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra | |
| Giromed Institute, SLP Barcelona, | |
| Grant Medical Foundation - Ruby Hall Clinic Pune, | |
| Green City Hospital Bhopal, Madhya Pradesh | |
| Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, | |
| HELIOS Klinikum Emil von Behring Berlin, State of Berlin | |
| Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem, | |
| Hamamatsu University Hospital Hamamatsu, Shizuoka | |
| Hangzhou First People's Hospital Hangzhou, ZJ | |
| Harmony Medical Research Institute, Inc Hialeah, Florida | |
| Health SURA Calle 100 Bogotá, DC | |
| Health SURA Chipichape Santiago de Cali, VAC | |
| Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni | |
| Henan provincial people's hospital Zhengzhou, HA | |
| Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken | |
| Hopital Avicenne Bobigny, | |
| Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva | |
| Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes | |
| Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo, | |
| Hospital CUF Tejo Lisbon, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Clinico Universitario Madrid, | |
| Hospital Dia do Pulmão Blumenau, Santa Catarina | |
| Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul | |
| Hospital Madre Teresa Belo Horizonte, Minas Gerais | |
| Hospital Nacional Cayetano Heredia Lima, | |
| Hospital Universitari de Bellvitge (IDIBELL) Barcelona, | |
| Hospital Universitario Central de Asturias Oviedo, Principality of Asturias | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Puerta De Hierro - Majadahonda Majadahonda, M | |
| Hospital Universitario de La Princesa Madrid, M | |
| Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais | |
| Hospital de Santa Marta Lisbon, | |
| Huadong Hospital Affiliated to Fudan University Shanghai, | |
| Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber | |
| Hôpital Bichat - Claude-Bernard Paris, Île-de-France Region | |
| Hôpital Larrey Toulouse, | |
| Ibamedica Santa Fe, | |
| Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi | |
| Inje University Haeundae Paik Hospital Haeundae-Gu, | |
| Inje University Ilsan Paik Hospital Goyang-si, Gyeonggi-do | |
| Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern | |
| Inspiration Research Toronto, Ontario | |
| Institute for Respiratory Health Nedlands, Western Australia | |
| Institute of Science Tokyo Hospital Tokyo, | |
| Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires | |
| Instituto Medico DAMIC Córdoba, Córdoba Province | |
| Instituto Medico INSARES SA Mendoza, M | |
| Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S | |
| Instituto Neumologico del Oriente Floridablanca, Santander Department | |
| Instituto de Seguridad Social del Estado de Mexico y Municipios (ISSEMYM) - Centro Medico Toluca Metepec, Edo De Mexico | |
| Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T | |
| Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı, | |
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo, | |
| Jehangir Clinical Development Center Pune, Maharashtra | |
| Jichi Medical University Hospital Shimotsuge-shi, Tochigi | |
| Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka | |
| Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba | |
| Kanagawa Cardiovascular and Respiratory Center Yokohama, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Kaplan Medical Center Rehovot, Central District | |
| Kepler Universitatsklinikum Linz, Upper Austria | |
| Kindai University Hospital Sakai, | |
| King George's Medical University Lucknow, Uttar Pradesh | |
| Klinikum der Universitat Munchen Munich, Bavaria | |
| Kobe City Medical Center General Hospital KobeShi, Hyōgo | |
| Krankenhaus Hietzing Vienna, | |
| Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest | |
| Kurume University Hospital Fukuoka, | |
| Kyorin University Hospital Mitaka-shi, Tokyo | |
| Kyushu University Hospital Fukuoka, | |
| Lankenau Medical Center Wynnewood, Pennsylvania | |
| Layrek Clinical Research Tulsa, Oklahoma | |
| Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire | |
| Local Institution - 0001 Lenexa, Kansas | |
| Local Institution - 0006 São Paulo, | |
| Local Institution - 0008 Munster, Northwest | |
| Local Institution - 0014 Antwerpen, VAN | |
| Local Institution - 0016 Lima, LIM | |
| Local Institution - 0020 Badalona, Barcelona | |
| Local Institution - 0032 Pittsburgh, Pennsylvania | |
| Local Institution - 0043 Changchun, Jilin | |
| Local Institution - 0055 Lima, | |
| Local Institution - 0060 Gainesville, Florida | |
| Local Institution - 0063 Brno, JM | |
| Local Institution - 0070 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0071 L'Hospitalet Del Llobregat, Barcelona [Barcelona] | |
| Local Institution - 0076 Villejuif, Val-de-Marne | |
| Local Institution - 0078 Monterrey, Nuevo León | |
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| Local Institution - 0104 Atlanta, Georgia | |
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| Local Institution - 0115 Trieste, TS | |
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| Local Institution - 0136 Buenos Aires, | |
| Local Institution - 0141 Aguascalientes, AGU | |
| Local Institution - 0148 Katowice, | |
| Local Institution - 0156 Piura, PIU | |
| Local Institution - 0157 Valencia, Comunidad Valencia | |
| Local Institution - 0162 Monterrey, Nuevo Leon | |
| Local Institution - 0163 Córdoba, VER | |
| Local Institution - 0179 Jasper, Alabama | |
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| Local Institution - 0223 La Tronche, Isère | |
| Local Institution - 0234 Mérida, YUC | |
| Local Institution - 0245 Nagpur, Maharashtra | |
| Local Institution - 0248 Guadalajara, JAL | |
| Local Institution - 0253 Melbourne, Victoria | |
| Local Institution - 0277 Uppsala, Uppsala Län [se-03] | |
| Local Institution - 0280 Helsinki, | |
| Local Institution - 0281 Oulu, North Ostrobothnia | |
| Local Institution - 0293 Darlinghurst, New South Wales | |
| Local Institution - 0296 Zhengzhou Shi, Henan | |
| Local Institution - 0303 Murdoch, Western Australia | |
| Local Institution - 0308 Paris, | |
| Local Institution - 0310 Milano, MI | |
| Local Institution - 0311 Lille CEDEX, | |
| Local Institution - 0312 Incheon, | |
| Local Institution - 0315 Caen, | |
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| Local Institution - 0317 Kitakyushu-shi, Fukuoka-Ken | |
| Local Institution - 0327 Sapporo, Hokkaido | |
| Local Institution - 0329 Okayama, | |
| Local Institution - 0340 Olomouc, | |
| Local Institution - 0357 Gosford, New South Wales | |
| Local Institution - 0376 Yinchuan, | |
| Local Institution - 0381 London, LND | |
| Local Institution - 0384 Koblenz, Rhineland-Palatinate | |
| Local Institution - 0387 Linz, | |
| Local Institution - 0390 Zagreb, City of Zagreb | |
| Local Institution - 0392 Sofia, | |
| Local Institution - 0397 Keçiören/Ankara, | |
| Local Institution - 0399 Athens, Attikí | |
| Local Institution - 0401 Miami, Florida | |
| Local Institution - 0412 A Coruña, A Coruña [La Coruña] | |
| Local Institution - 0413 Guadalajara, | |
| Local Institution - 0422 Ankara, | |
| Local Institution - 0423 Kitakyushu-shi, Fukuoka | |
| Local Institution - 0427 Singapore, Central Singapore | |
| Local Institution - 0432 George Town, Pulau Pinang | |
| Local Institution - 0435 Louisville, Kentucky | |
| Local Institution - 0439 Dammam, Eastern Province | |
| Local Institution - 0443 Box Hill, Victoria | |
| Local Institution - 0444 Hermosillo, Sonora | |
| Local Institution - 0445 Riyadh, Riyadh Region | |
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| Local Institution - 0448 Guadalajara, Jalisco | |
| Local Institution - 0449 Ampang, Selangor | |
| Local Institution - 0450 Tulsa, Oklahoma | |
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| Local Institution - 0452 Atlanta, Georgia | |
| Local Institution - 0453 Lembah Pantai, Kuala Lumpur | |
| Local Institution - 0454 Pilea Chortiatis, Thessaloniki | |
| Local Institution - 0455 Seongnam, | |
| Local Institution - 0460 Graz, Styria | |
| Local Institution - 0462 Auckland, | |
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| MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Marengo CIMS Hospital Ahmedabad, Gujarat | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
| Matsusaka Municipal Hospital Matsusaka-shi, Mie-ken | |
| Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi | |
| McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical University of South Carolina- College of Medicine Charleston, South Carolina | |
| Medicos Internistas de Caldas Manizales, CL | |
| Mercy St. Vincent Medical Center Toledo, Ohio | |
| Meris Clinical Research Brandon, Florida | |
| Metroplex Pulmonary and Sleep Center McKinney, Texas | |
| Midland Healthcare & Research Center Lucknow, | |
| Monteregie Centre de Recherche Greenfield Park, Quebec | |
| Myongji Hospital Goyang-si, Gyeonggi-do | |
| NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH | |
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| NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Nagasaki University Hospital Nagasaki, | |
| Nagoya University Hospital Showa-Ku Nagoya, | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS | |
| National Hospital Organization - Okinawa National Hospital Ginowan-Shi, Okinawa | |
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| National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei, | |
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| Nilratan Sircar (NRS) Medical College & Hospital Kolkata, West Bengal | |
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| North Bristol NHS Trust - Southmead Hospital Bristol Bristol, BST | |
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| Northwestern Memorial Hospital Chicago, Illinois | |
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| OSF Saint Francis Medical Center Peoria, Illinois | |
| OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma | |
| Ocala Lung & Critical Care Ocala, Florida | |
| Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark | |
| Omega Research Consultants LLC DeBary, Florida | |
| Oregon Health & Science University - Pulmonary Clinic Portland, Oregon | |
| Ospedale Colonnello D'Avanzo Foggia Foggia, | |
| Ospedale Policlinico di Siena Siena, | |
| Our Lady of Lourdes Hospital - Drogheda Drogheda, LH | |
| Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, Oxfordshire | |
| Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire | |
| Peking Union Medical College Hospital Beijing, | |
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| Praxis fur Pneumologie Marburg, HE | |
| Pulmonary Group of Central Florida, LLC - Leesburg Leesburg, Florida | |
| Pulmonary Specialists of the Palm Beaches Loxahatchee Groves, Florida | |
| Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Quebec Heart and Lung Institute Quebec, | |
| Rabin Medical Center - Hasharon Hospital Petah Tikva, | |
| Rambam Health Care Campus - Pulmonology Haifa, | |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH | |
| Renmin Hospital of Wuhan University Wuhan, | |
| Respira Salud Clinica Integral Godoy Cruz, M | |
| Royal Adelaide Hospital Adelaide, | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building Chicago, Illinois | |
| SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land | |
| Saiseikai Kumamoto Hospital Kumamoto, | |
| Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul | |
| Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia | |
| Sapporo Medical University Hospital Sapporo, Hokkaido | |
| Scripps Clinic Torrey Pines La Jolla, California | |
| Semmelweis Egyetem Pulmonologiai Klinika Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT | |
| Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH | |
| Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai, | |
| Shanghai Pulmonary Hospital Shanghai, Shanghai Municipality | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shenyang Chest Hospital Shenyang, Liaoning | |
| Shenzhen People's Hospital Shenzhen, | |
| Shimane University Hospital Izumo-Shi, | |
| Shree Hospital and Critical Care Centre Nagpur, MH | |
| Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu, | |
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| SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul | |
| South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas | |
| Southeastern Research Center Winston-Salem, North Carolina | |
| St Francis Sleep Allergy & Lung Institute Clearwater, Florida | |
| St. Antonius Ziekenhuis Nieuwegein, Utrecht | |
| St. John's Medical College Bangalore, | |
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| Stanford University School of Medicine Stanford, California | |
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| Synergy Respiratory & Cardiac Care Sherwood Park, Alberta | |
| T.C.S.B. Süreyyapasa Gögüs Hastaliklari Egitim Ve Arastirma Hastanesi Maltepe, | |
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| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania | |
| Tenri Hospital Tenri-Shi, | |
| The Affiliated Hospital of Inner Mongolia Medical University Hohhot, | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu | |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheonsi Weonmigu, | |
| The First Affiliated Hospital of Guangzhou Medical University Guangzhou, | |
| The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX | |
| The First Affiliated Hospital of Ningbo University Ningbo, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan | |
| The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Jikei University Hospital Minato-ku, Tokyo | |
| The Lung Centre Vancouver, British Columbia | |
| The Lung Research Center Chesterfield, Missouri | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| The Prince Charles Hospital Chermside, Queensland | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, | |
| The Second Hospital of Hebei Medical University Shijiazhuang, Hebi | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| The Third Hospital of Hebei Medical University Shijiazhuang, | |
| The University of Alabama at Birmingham Birmingham, Alabama | |
| The University of Chicago Medicine Chicago, Illinois | |
| Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, | |
| Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria | |
| Tianjin Chest Hospital Tianjin, TJ | |
| Tianjin Medical University General Hospital Tianjin, Tianjin Municipality | |
| Toho University - Omori Medical Center Tokyo, | |
| Tokyo Medical University Hospital Shinjuku-Ku, Tokyo | |
| Toranomon Hospital Minato-ku, Tokyo | |
| Tosei General Hospital Seto, | |
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| UC Irvine Medical Center Orange, California | |
| UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD) Pittsburgh, Pennsylvania | |
| UZ Leuven Leuven, | |
| Ulsan University Hospital (UUH) Dong-gu, Ulsan | |
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| Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures, | |
| Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon, | |
| Unidade Local de Saude de Santo Antonio, E.P.E. Porto, | |
| Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto, | |
| Unidade Local de Saúde do Algarve, EPE Faro, | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Unity Hospital Fridley, Minnesota | |
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| Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig, | |
| University General Hospital Attikon Athens, | |
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| University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham, | |
| University of California UC Davis Medical Center Sacramento, California | |
| University of California, San Francisco Medical Center- Pulmonary Practice San Francisco, California | |
| University of Cincinnati College of Medicine Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado | |
| University of Florida (UF) Health Shands Hospital Gainesville, Florida | |
| University of Fukui Hospital Yoshida-gun, Fukui | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Kansas Medical Center (KUMC) Kansas City, Kansas | |
| University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland | |
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| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee | |
| Velocity Clinical Research Germany GmbH Ahrensburg, | |
| Vivantes Klinikum Neukolln Berlin, | |
| Vzw Az Groeninge Kortrijk, | |
| WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul | |
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| Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna, | |
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| Wuxi People's Hospital Wuxi, Jiangsu | |
| Xi'an International Medical Center Hospital Xi'an, Shan3xi | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE | |
| Yonsei University Health System, Severance Hospital Seoul, | |
| Zuyderland Medisch Centrum, Sittard-Geleen Heerlen, | |
| hospital Italiano de Buenos Aires Ciudad Autonoma de, |
Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative
ctrrecruit@vcu.edu
NCT04929041
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Inclusion Criteria:
* Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
* PD-L1 expression tumor proportion score (TPS) \< 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
* For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
* Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 gray (Gy) doses of radiation
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC
* No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer
* No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration
* No systemic immunostimulatory or immunosuppressive drugs, including \> 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter. Steroid premedication per local standard is allowed
* \>= 1 week prior to registration since palliative (including central nervous system \[CNS\]) radiotherapy to any tumor site
* No prior allogeneic tissue/solid organ transplant
* No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
* No current pneumonitis or history of non-infectious pneumonitis that required steroids
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration
* No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* No known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids
* Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
* No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible
* No hypersensitivity (\>= grade 3) to immunotherapy and/or any of its excipients
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Calculated (Calc.) creatinine clearance \>= 45 mL/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, BIOLOGICAL: Ipilimumab, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
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Show 169 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| 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) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.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 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 | |
| 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 Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Fremont - Rideout Cancer Center Marysville, California | |
| Geisinger Medical Center Danville, 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) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| 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 | |
| Lenox Hill Hospital New York, New York | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| 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-Franciscan Healthcare La Crosse, Wisconsin | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Morton Plant Hospital Clearwater, Florida | |
| Mount Sinai Chelsea New York, New York | |
| Mount Sinai Hospital New York, New York | |
| Mount Sinai West New York, New York | |
| 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) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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 University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Health Saint Joseph Medical Center Reading, Pennsylvania | Site Public Contact - (dward1@pennstatehealth.psu.edu) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| Providence Queen of The Valley Napa, California | |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Roswell Park Cancer Institute Buffalo, New York | |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| 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 Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The Iowa Clinic PC West Des Moines, Iowa | |
| 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 Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, 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 Joseph Mercy Oakland Hospital Pontiac, 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) |
| UCHealth Greeley Hospital Greeley, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| 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 Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| 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 Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | |
| Upstate Cancer Center at Oswego Oswego, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Winter Haven Hospital Winter Haven, Florida | Site Public Contact - (Research.CTO@baycare.org) |
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Toll Free Number - Trialsites@msd.com
NCT06074588
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
* Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
* Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
* Measurable disease per RECIST 1.1 as assessed by the local site investigator.
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
* Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Exclusion Criteria:
* Has predominantly squamous cell histology NSCLC.
* Has mixed tumor(s) with small cell elements.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
* Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention.
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I-containing ADC.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Active infection requiring systemic therapy.
* History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
* Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Docetaxel, DRUG: Pemetrexed
Non-small Cell Lung Cancer (NSCLC)
Anaplastic lymphoma kinase (ALK), Antibody-drug conjugate (ADC), Epidermal growth factor receptor (EGFR), Trophoblast cell-surface antigen 2 (TROP2)
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Show 192 locations
Study Locations
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| Location | Contacts |
|---|---|
| "Theagenio" Cancer Hospital of Thessaloniki ( Site 2703) Thessaloniki, Central Macedonia | |
| A. C. Camargo Cancer Center-CAPEC ( Site 0442) São Paulo, | |
| ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704) Chaidari, Athens, Attica | |
| Adana Medical Park Seyhan Hastanesi ( Site 2506) Adana, | |
| Aichi Cancer Center ( Site 3400) Nagoya, Aichi-ken | |
| Anhui Provincial Cancer Hospital ( Site 2830) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501) Ankara, | |
| Aretaieio Hospital ( Site 2702) Athens, Attica | |
| Asan Medical Center ( Site 3801) Seoul, | |
| Asian Hospital and Medical Center ( Site 3605) Muntinlupa, National Capital Region | |
| Asklepios Klinik Harburg ( Site 1403) Hamburg, | |
| Atlantic Health System Morristown Medical Center ( Site 0031) Morristown, New Jersey | |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810) Beijing, Beijing Municipality | |
| Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815) Beijing, Beijing Municipality | |
| Bradfordhill-Clinical Area ( Site 0507) Santiago, Region M. de Santiago | |
| CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602) San Juan City, Metro Manila, National Capital Region | |
| CENTRE LEON BERARD ( Site 1305) Lyon Cedex08, Auvergne-Rhône-Alpes | |
| CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300) Rouen, Haute-Normandie | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706) Guadalajara, Jalisco | |
| Cancer Institute Hospital of JFCR ( Site 3402) Koto, Tokyo | |
| Capital Health Medical Center - Hopewell ( Site 0006) Pennington, New Jersey | |
| Centro Investigacion Cancer James Lind ( Site 0513) Temuco, Región de la Araucanía | |
| Centro de Estudios Clínicos SAGA ( Site 0517) Santiago, Region M. de Santiago | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0701) Oaxaca City, Oaxaca | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 3906) Kaohsiung City, | |
| Changhua Christian Hospital ( Site 3908) Changhua, | |
| Chi Mei Medical Center ( Site 3910) Tainan City, Tainan | |
| Chiba University Hospital ( Site 3411) Chiba, | |
| Chongqing University Cancer Hospital-Medical Oncology ( Site 2814) Chongqing, Chongqing Municipality | |
| Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807) Hwasun, Jeonranamdo | |
| Chungbuk National University Hospital-Internal medicine ( Site 3809) Cheongju-si, North Chungcheong | |
| Chungnam national university hospital ( Site 3808) Junggu, Taejon-Kwangyokshi | |
| Clinica Integral Internacional de Oncología ( Site 0705) Puebla City, | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0501) Talca, Maule Region | |
| Clinica Universidad de Navarra-Medical Oncology ( Site 2306) Madrid, | |
| Clínica RedSalud Vitacura ( Site 0511) Santiago, Region M. de Santiago | |
| E-Da hospital ( Site 3911) Kaohsiung City, | |
| Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504) Bornova, İzmir | |
| Englewood Hospital and Medical Center ( Site 0033) Englewood, New Jersey | |
| Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705) Athens, Attica | |
| FALP-UIDO ( Site 0509) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 4004) Khon Kaen, | |
| Faculty of Medicine Siriraj Hospital ( Site 4000) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102) Olomouc, | |
| Fakultni nemocnice Plzen ( Site 1104) Pilsen, Plzeň Region | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800) Milan, Lombardy | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802) Rome, Lazio | |
| Fudan University Shanghai Cancer Center-Oncology ( Site 2811) Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital ( Site 2819) Fuzhou, Fujian | |
| Fujita Health University Hospital ( Site 3419) Toyoake, Aichi-ken | |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444) Barretos, São Paulo | |
| Groupe hospitalier Paris saint Joseph. ( Site 1307) Paris, | |
| Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816) Nanning, Guangxi | |
| Gunma Prefectural Cancer Center ( Site 3418) Otashi, Gunma | |
| Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603) London, London, City of | |
| H.R.U Málaga - Hospital General-Oncology ( Site 2302) Málaga, Malaga | |
| HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304) Barcelona, Catalonia | |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303) Madrid, Madrid, Comunidad de | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301) Pozuelo de Alarcón, Madrid | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500) Ankara, | |
| Hanoi Oncology Hospital ( Site 4102) Hanoi, Hanoi | |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2807) Harbin, Heilongjiang | |
| Hattiesburg Clinic Hematology/Oncology ( Site 0010) Hattiesburg, Mississippi | |
| Henan Cancer Hospital-henan cancer hospital ( Site 2813) Zhengzhou, Henan | |
| Hong Kong Integrated Oncology Centre ( Site 3200) Central, | |
| Hospital Insular de Gran Canaria-Oncology ( Site 2305) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440) Porto Alegre, Rio Grande do Sul | |
| Hospital Paulistano-Americas Oncologia ( Site 0441) São Paulo, | |
| Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502) Kota Bharu, Kelantan | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300) Barcelona, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704) Monterrey, Nuevo León | |
| Hubei Cancer Hospital ( Site 2809) Wuhan, Hubei | |
| Hunan Cancer Hospital-thoracic oncology II ( Site 2808) Changsha, Hunan | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806) Meldola, Emilia-Romagna | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303) Bordeaux, Aquitaine | |
| Institut Curie-Thorax Institute ( Site 1304) Paris, | |
| Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011) Warsaw, Masovian Voivodeship | |
| Istituto Clinico Humanitas ( Site 1803) Rozzano, Lombardy | |
| Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805) Rome, Roma | |
| Jilin Province Tumor Hospital-clinical research ( Site 2803) Changchun, Jilin | |
| Jinan Central Hospital-oncology department ( Site 2802) Jinan, Shandong | |
| K Hospital - National Cancer Hospital ( Site 4105) Hanoi, Hanoi | |
| K2 Oncology ( Site 0514) Santiago, Region M. de Santiago | |
| Kanagawa Cancer Center ( Site 3404) Yokohama, Kanagawa | |
| Kanazawa University Hospital ( Site 3414) Kanazawa, Ishikawa-ken | |
| Kangbuk Samsung Hospital ( Site 3813) Seoul, | |
| Kansai Medical University Hospital ( Site 3410) Hirakata, Osaka | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912) Kaohsiung City, | |
| Karmanos Cancer Institute ( Site 0018) Detroit, Michigan | |
| Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400) Essen, North Rhine-Westphalia | |
| Klinikum Chemnitz - Flemmingstraße ( Site 1401) Chemnitz, Saxony | |
| Konkuk University Medical Center ( Site 3812) Seoul, | |
| Korea University Guro Hospital-Internal Medicine ( Site 3800) Seoul, | |
| Kyushu University Hospital ( Site 3407) Fukuoka, | |
| Lampang Cancer Hospital ( Site 4005) Muang, Changwat Lampang | |
| Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447) Natal, Rio Grande do Norte | |
| LinYi Cancer Hospital ( Site 2804) Linyi, Shandong | |
| Mackay Memorial Hospital-Chest Medicine ( Site 3902) Taipei, | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 4003) Muang, Chiang Mai | |
| Manila Doctors Hospital-Clinical Trial Office ( Site 3604) Manila, National Capital Region | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100) Brno, Brno-mesto | |
| Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) Jacksonville, Florida | |
| Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) Rochester, Minnesota | |
| Medipol Mega Universite Hastanesi-oncology ( Site 2505) Stanbul, Istanbul | |
| Mid Florida Hematology and Oncology Center ( Site 0005) Orange City, Florida | |
| Miyagi Cancer Center ( Site 3416) Natori-shi, Miyagi | |
| Monash Health-Oncology Research ( Site 3001) Clayton, Victoria | |
| Nanjing Drum Tower Hospital ( Site 2812) Nangjing, Jiangsu | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000) Warsaw, Masovian Voivodeship | |
| National Cancer Center Hospital East ( Site 3406) Kashiwa, Chiba | |
| National Cancer Center-Lung Cancer Center ( Site 3810) Goyang-si, Kyonggi-do | |
| National Cancer Institute-Radiotherapy and Oncology ( Site 3504) Putrajaya, Kuala Lumpur | |
| National Cheng Kung University Hospital ( Site 3909) Tainan City, | |
| National Hospital Organization Kyushu Medical Center ( Site 3412) Fukuoka, | |
| National Hospital Organization Shikoku Cancer Center ( Site 3415) Matsuyama, Ehime | |
| National Lung Hospital-Oncology Department ( Site 4104) Hanoi, Hanoi | |
| National Taiwan University Cancer Center (NTUCC) ( Site 3903) Taipei City, Taipei | |
| National Taiwan University Hospital - Hsinchu branch ( Site 3907) Hsinchu, | |
| National Taiwan University Hospital-Oncology ( Site 3904) Taipei, | |
| Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103) Ostrava, Ostrava Mesto | |
| Niigata Cancer Center Hospital ( Site 3405) Niigata, Niigata | |
| Nippon Medical School Hospital ( Site 3408) Tokyo, | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) Marietta, Georgia | |
| Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446) São Paulo, | |
| ONCOCENTRO APYS-ACEREY ( Site 0500) Viña del Mar, Región de Valparaíso | |
| Okayama University Hospital ( Site 3417) Okayama, | |
| Orlandi Oncologia-Oncology ( Site 0504) Santiago, Region M. de Santiago | |
| Osaka International Cancer Institute ( Site 3413) Osaka, | |
| Papageorgiou General Hospital of Thessaloniki ( Site 2701) Thessaloniki, | |
| Pontificia Universidad Catolica de Chile ( Site 0502) Santiago, Region M. de Santiago | |
| Princess Margaret Cancer Centre ( Site 0204) Toronto, Ontario | |
| Princess Margaret Hospital-Department of Oncology ( Site 3201) Lai Chi Kok, | |
| Pusan National University Hospital ( Site 3805) Busan, Pusan-Kwangyokshi | |
| Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811) Yangsan, Kyongsangnam-do | |
| Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204) Kowloon, | |
| Queen Mary Hospital ( Site 3203) Hksar, | |
| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606) London, Kensington and Chelsea | |
| Rabin Medical Center ( Site 1703) Petah Tikva, | |
| Rambam Health Care Campus-Oncology Division ( Site 1702) Haifa, | |
| Royal Marsden Hospital (Sutton) ( Site 2605) Sutton, Surrey | |
| ST. LUKE'S MEDICAL CENTER ( Site 3601) Quezon City, National Capital Region | |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 3802) Seoul, | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 3500) Kuching, Sarawak | |
| Sendai Kousei Hospital ( Site 3401) Sendai, Miyagi | |
| Seoul National University Bundang Hospital ( Site 3806) Seongnam, Kyonggi-do | |
| Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804) Seoul, | |
| Shaare Zedek Medical Center ( Site 1700) Jerusalem, | |
| Shanghai Chest Hospital-Oncology department ( Site 2800) Shanghai, Shanghai Municipality | |
| Shizuoka Cancer Center ( Site 3403) Nagaizumi-cho,Sunto-gun, Shizuoka | |
| Sichuan Cancer hospital. ( Site 2822) Chengdu, Sichuan | |
| Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828) Hangzhou, Zhejiang | |
| Songklanagarind hospital ( Site 4001) Hat Yai, Changwat Songkhla | |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818) Guangzhou, Guangdong | |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600) London, London, City of | |
| St. George Private Hospital ( Site 3004) Kogarah, New South Wales | |
| Sunpasitthiprasong Hospital-Oncology ( Site 4002) Ubon Ratchathani, | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005) Kielce, Świętokrzyskie Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) Istanbul, | |
| THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600) Iloilo City, Iloilo | |
| THE MEDICAL CITY-Cancer Research Center ( Site 3603) Pasig, National Capital Region | |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700) Athens, Attica | |
| Taipei Medical University Hospital ( Site 3900) Taipei, | |
| Takarazuka City Hospital ( Site 3409) Takarazuka, Hyōgo | |
| Tennessee Oncology (0036) Nashville, Tennessee | Tamjeed Ahmed - (tahmed@tnonc.com) |
| The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803) Suwon, Kyonggi-do | |
| The Christie NHS Foundation Trust ( Site 2604) Manchester, | |
| The Clatterbridge Cancer Centre ( Site 2602) Metropolitan Borough of Wirral, | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University ( Site 2820) Xiamen, Fujian | |
| The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821) Nanchang, Jiangxi | |
| The Second Xiangya Hospital of Central South University ( Site 2827) Changsha, Hunan | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 2805) Wuhan, Hubei | |
| UCLA Hematology/Oncology - Santa Monica ( Site 0023) Los Angeles, California | |
| Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402) Dresden, Saxony | |
| Universitaetsklinikum Freiburg ( Site 1405) Freiburg, Brandenburg | |
| University Of Nebraska Medical Center ( Site 0011) Omaha, Nebraska | |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015) Cincinnati, Ohio | |
| University of Texas MD Anderson (0037) Houston, Texas | Yasir Elamin - (yyelamin@mdanderson.org) |
| Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407) Göttingen, Lower Saxony | |
| VCU Health Adult Outpatient Pavillion ( Site 0026) Richmond, Virginia | |
| Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105) Prague, | |
| West China Hospital, Sichuan University-Lung cancer center ( Site 2826) Chengdu, Sichuan | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) Melbourne, Victoria | |
| Westmead Hospital ( Site 3000) Westmead, New South Wales | |
| William Osler Health System ( Site 0205) Brampton, Ontario | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009) Torun, Kuyavian-Pomeranian Voivodeship | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001) Przemyśl, Podkarpackie Voivodeship | |
| Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806) Wuhan, Hubei | |
| Yunnan Province Cancer Hospital ( Site 2824) Kunming, Yunnan | |
| Zhejiang Cancer Hospital ( Site 2829) Hangzhou, Zhejiang |
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)
Erika Enright - eenright@uw.edu
NCT06654752
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Inclusion Criteria:
• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking ETI or ivacaftor for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
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Show 33 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois | Mariah Flowers - (maflowers@luriechildrens.org) |
| Boston Children's Hospital & Harvard University Boston, Massachusetts | Ethan Ito - (ethan.ito@childrens.harvard.edu) |
| British Columbia Children's Hospital Vancouver, British Columbia | Madison Weir - (Madison.Weir@bcchr.ca) |
| Children's Healthcare of Atlanta & Emory University Atlanta, Georgia | Joy Dangerfield - (jdanger@emory.edu) |
| Children's Hospital of Colorado Aurora, Colorado | Mary Cross - (Mary.Cross@childrenscolorado.org) |
| Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California | Jared Lopez, BA - (jalopez@chla.usc.edu) |
| Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania | Erin Donnelly - (donnellye4@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu) |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | Briana Escobar, CRC - (Briana.Escobar@childrensmn.org) |
| Children's Mercy Hospital Kansas City, Missouri | Jana Lomonte - (jblomonte@cmh.edu) |
| Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin | Laura Roth, CCRC - (lroth@mcw.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org) |
| Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland | Jamelia Maynard - (jmaynar8@jhmi.edu) |
| Medical University of South Carolina Charleston, South Carolina | Audra Wiser - (wisera@musc.edu) |
| Oregon Health & Science University Portland, Oregon | Pierce Nusbaum - (nusbaum@ohsu.edu) |
| Rady Children's Hospital at University of California San Diego San Diego, California | Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu) |
| Riley Hospital for Children & Indiana University Indianapolis, Indiana | Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri | Emily Schulte, RN, BSN - (e.burns@wustl.edu) |
| Stanford University Palo Alto, California | Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu) |
| Texas Children's Hospital & Baylor College of Medicine Houston, Texas | Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu) |
| The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama | Ashlyn Hastings - (aehastings@uabmc.edu) |
| The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario | Sheryl Hewko - (sheryl.hewko@sickkids.ca) |
| The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota | Alyssa Perry - (ahperry@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Michigan Health System Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Caroline Flowers, CRC - (caroline_flowers@med.unc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu) |
| University of Texas Southwestern & Children's Health Dallas, Texas | Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu) |
| Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont | Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@vcuhealth.org) |
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer (Krascendo 1)
Reference Study ID Number: BO45217 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT06497556
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Inclusion Criteria:
* Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
* Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Documentation of the presence of a KRAS G12C mutation
* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of \>= 12 weeks
Exclusion Criteria:
* Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known concomitant second oncogenic driver
* Mixed small-cell lung cancer or large cell neuroendocrine histology
* Known and untreated, or active central nervous system (CNS) metastases
* Leptomeningeal disease or carcinomatous meningitis
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
* Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
* Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
* More than 30 Gy of radiotherapy to the lung within 6 months of randomization
* Uncontrolled tumor-related pain
* Unresolved toxicities from prior anticancer therapy
* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer DRUG: Divarasib, DRUG: Sotorasib, DRUG: Adagrasib
Non-small Cell Lung Cancer, KRAS G12C Lung Cancer
Advanced Non-Small Cell Lung Cancer, KRAS G12 Lung Cancer, Advanced Lung Cancer, Metastatic lung cancer, Divarasib, KRAS G12C Inhibitor, KRAS G12C Positive, KRAS Mutation, KRAS G12C Mutation, Lung Cancer Mutation
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Show 253 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O. Universitaria Di Parma Parma, Emilia-Romagna | |
| A.O.U. Maggiore della Carità Novara, Piedmont | |
| AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello Palermo, Sicily | |
| ARKE Estudios Clínicos S.A. de C.V. Mexico City, | |
| AUSL della Romagna Ravenna, Emilia-Romagna | |
| AZ Delta (Campus Rumbeke) Roeselare, | |
| AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica Bologna, Emilia-Romagna | |
| AZORG Campus Aalst-Moorselbaan Aalst, | |
| Aarhus Universitetshospital Aarhus, | |
| Addenbrooke's Hospital Cambridge, | |
| Ag. Loukas Hospital Thessaloniki, | |
| Allegheny Cancer Center Pittsburgh, Pennsylvania | |
| Amphia Ziekenhuis Breda, | |
| Asklepios Fachkliniken GmbH Gauting, | |
| Asst Papa Giovanni XXIII Bergamo, | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Az. Osp. Pugliese Ciaccio Catanzaro, Calabria | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia Udine, Friuli Venezia Giulia | |
| Banner Health MD Anderson AZ Phoenix, Arizona | |
| Banner Health MD Anderson AZ Phoenix, Arizona | |
| Baptist Clinical Research Institute St Louis, Missouri | |
| Baptist Health Lexington Lexington, Kentucky | |
| Bay Pines Foundation Inc Bay Pines, Florida | |
| Beatson West of Scotland Cancer Centre Glasgow, | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Blackpool Victoria Hospital Blackpool, | |
| CH de Saint Quentin Saint-Quentin, | |
| CHRU Brest Brest, | |
| CHRU Lille Lille, | |
| CHU Angers Angers, | |
| CHU Bordeaux Pessac, | |
| CHU Montpellier Montpellier, | |
| CHU UCL Mont-Godinne Mont-godinne, | |
| CHU de Liège (Sart Tilman) Liège, | |
| CHUC - Unidade de Pneumologia Oncológica Coimbra, | |
| Cancer Specialists of North Florida Jacksonville, Florida | |
| Cancer and Hematology Centers of Western Michigan Grand Rapids, Michigan | |
| Castle Hill Hospital Hull, | |
| Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer Nice, | |
| Centre Leon Berard Lyon, | |
| Centro Clinico Champalimaud Lisbon, | |
| Centro Hospitalar do Porto ? Hospital de Santo António Porto, | |
| Centro Oncológico Korben Buenos Aires, | |
| Centro de Infusion E Investigacion Oncologia de Saltillo Sc Saltillo, Coahuila | |
| Chang Gung Medical Foundation - Linkou Taoyuan District, | |
| Charité Universitätsmedizin Berlin, Med Klinik Infekto und Pneumo Berlin, | |
| Chonnam National University Hwasun Hospital Jeollanam-do, | |
| Chru de Strasbourg Strasbourg, | |
| Chu Toulouse Bron, | |
| Chung Shan Medical University Hospital Taichung, | |
| Chungbuk National University Hospital Cheongju-si, North Chungcheong | |
| Clinica Onconeo Campo Grande, Mato Grosso do Sul | |
| Cliniques Universitaires St-Luc Brussels, | |
| Clínica Adventista Belgrano Ciudad de Buenos Aires, | |
| Clínica Integral Internacional de Oncología S de RL de CV Puebla City, Puebla | |
| Columbia University Medical Center New York, New York | |
| Community Clinical Trials Orange, California | |
| Curie Oncology (Farrer) Singapore, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Dana Farber/Harvard Cancer Center (Foxborough) Foxborough, Massachusetts | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii Wroc?aw, | |
| East Carolina University Greenville, North Carolina | |
| Errikos Dynan Hospital Athens, | |
| Evangelische Lungenklinik Berlin Berlin, | |
| Firsthealth of The Carolinas Pinehurst, North Carolina | |
| Florida Cancer Specialists West Palm Beach, Florida | |
| Florida Cancer Specialists West Palm Beach, Florida | |
| Florida Cancer Specialists. St. Petersburg, Florida | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Gachon University Gil Medical Center Incheon, | |
| GenesisCare North Shore St Leonards, New South Wales | |
| Gibbs Cancer Center & Research Institute Spartanburg, South Carolina | |
| Guy's Hospital - Cancer Centre London, | |
| Gävle Sjukhus Gävle, | |
| Helios Klinikum Emil von Behring GmbH Berlin, | |
| Helsinki University Central Hospital Helsinki, | |
| Henry Ford Health System;Clinical Trials Office Detroit, Michigan | |
| Herlev Hospital Herlev, | |
| Hia Sainte Anne Toulon, | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hong Kong Integrated Oncology Centre Hong Kong, | |
| Hopital Louis Pradel Bron, | |
| Hopital Tenon Paris, | |
| Hospital Alemão Oswaldo Cruz São Paulo, | |
| Hospital Brasilia Lago Sul, | |
| Hospital Britanico Buenos Aires, | |
| Hospital Civil De Guadalajara Fray Antonio Alcalde Guadalajara, Jalisco | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Mãe de Deus Porto Alegre, Rio Grande do Sul | |
| Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul | |
| Hospital Nuestra Senora de Valme Seville, Sevilla | |
| Hospital Regional Universitario de Malaga Málaga, | |
| Hospital Sao Rafael - HSR Salvador, Estado de Bahia | |
| Hospital Sírio-Libanês São Paulo, São Paulo | |
| Hospital Universitario La Fe Valencia, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Vall Hebron Barcelona, | |
| Hospital de Base de Sao Jose do Rio Preto São José do Rio Preto, São Paulo | |
| Hospital de Braga Braga, | |
| Hospital de Cancer de Barretos Barretos, São Paulo | |
| Hsin-Chu Branch of National Taiwan University Hospital Hsinchu, | |
| IPO do Porto Porto, | |
| IRCCS Istituto Clinico Humanitas Rozzano (MI), Lombardy | |
| IRCCS Istituto Oncologico Veneto (IOV) Padua, Veneto | |
| IRCCS Istituto Regina Elena (IFO) Rome, Lazio | |
| IU Health Ball Memorial Hospital Muncie, Indiana | |
| Institut Catala d Oncologia Hospitalet L'Hospitalet de Llobregat, Barcelona | |
| Institut für Lungenforschung Wien Vienna, | |
| Instytut "Centrum Zdrowia Matki Polki" ?ód?, | |
| Instytut Gruzlicy i Chorob Pluc Warsaw, | |
| Irccs Ist. Tumori Giovanni Paolo Ii Bari, Apulia | |
| Isala Zwolle, | |
| JPS Health Network Fort Worth, Texas | |
| Jeroen Bosch Ziekenhuis 's-Hertogenbosch, | |
| Jessa Zkh (Campus Virga Jesse) Hasselt, | |
| Jewish General Hospital Montreal, Quebec | |
| KEM/Evang. Kliniken Essen Mitte gGmbH Essen, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Keimyung University Dongsan Medical Center Daegu, | |
| Kindai University Hospital Sakai, | |
| Kinghorn Cancer Centre Darlinghurst, New South Wales | |
| Klinik Penzing Vienna, | |
| Klinikum Bogenhausen München, | |
| Klinikum Braunschweig Braunschweig, | |
| Klinikum Esslingen Esslingen am Neckar, | |
| Klinikum Koeln-Merheim Cologne, | |
| Klinikum Würzburg Mitte gGmbH Würzburg, | |
| Korea University Anam Hospital Seoul, | |
| Korea University Guro Hospital Seoul, | |
| Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II Krakow, | |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH Halle, | |
| Krankenhaus Nord - Klinik Floridsdorf Vienna, | |
| Kujawsko-Pomorskie Centrum Pulmonologii Bydgoszcz, | |
| Kuopio Uni Hospital Kuopio, | |
| Kyungpook National University Chilgok Hospital Daegu, | |
| Kyushu University Hospital Fukuoka, | |
| Liverpool Hospital Liverpool, | |
| Los Angeles Cancer Network Glendale, California | |
| LungenClinic Grosshansdorf GmbH Großhansdorf, | |
| Lungenfachklinik Immenhausen Immenhausen, Hesse | |
| Lungenklinik Hemer Hemer, | |
| Lyell McEwin Hospital Elizabeth Vale, South Australia | |
| MD Anderson Cancer Center Houston, Texas | |
| Medisch Centrum Haaglanden, locatie Antoniushove Leidschendam, | |
| Metropolitan Hospital Fourth Oncology Clinic Faliro, | |
| Minnesota Oncology Edina Edina, Minnesota | |
| Mission Cancer + Blood - IMMC Des Moines, Iowa | |
| Mount Sinai Medical Center Miami Beach, Florida | |
| Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad Warsaw, | |
| National Cancer Center Hospital Tokyo, | |
| National Cancer Centre Singapore, | |
| National Taiwan University Hospital Taipei, | |
| Nebraska Methodist Estabrook Cancer Center Omaha, Nebraska | |
| New England Cancer Specialists Westbrook, Maine | |
| New York Cancer & Blood Specialists The Bronx, New York | |
| New York Cancer & Blood Specialists - New Hyde Park New Hyde Park, New York | |
| New York Cancer and Blood Specialists-Central Park Hematology & Oncology New York, New York | |
| Niigata Cancer Center Hospital Niigata, | |
| North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists Shirley, New York | |
| Norton Cancer Institute- Poplar Louisville, Kentucky | |
| Nottingham City Hospital Nottingham, | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| Okayama University Hospital Okayama, | |
| Oncoclínicas Rio de Janeiro S.A. Rio de Janeiro, | |
| Oncology Associates of Oregon, P.C Eugene, Oregon | |
| Oregon Health & Science University Portland, Oregon | |
| Ospedale Civile SS Annunziata Sassari, Sardinia | |
| Ospedale Policlinico San Martino Genoa, Liguria | |
| PanAmerican Clinical Research, Querétaro Queréaro, Querétaro | |
| Peter MacCallum Cancer Centre Melbourne, | |
| Pius Hospital Oldenburg Oldenburg, | |
| Prince of Wales Hosp Shatin, | |
| Princess Margaret Cancer Center Toronto, | |
| Pusan National University Hospital Busan, | |
| Pusan National University Yangsan Hospital Yangsan, | |
| Queen Mary Hospital Hong Kong, | |
| Radomskie Centrum Onkologii Radom, | |
| Regionshospitalet Gødstrup Herning, | |
| Renown Regional Medical Center Hospital Reno, Nevada | |
| Royal Marsden Hospital (Sutton) Sutton, | |
| Royal Marsden Hospital - London London, | |
| Rush University Medical Center Chicago, Illinois | |
| SCRI Mark H. Zangmeister Center Columbus, Ohio | |
| SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein Löwenstein, | |
| Samsung Medical Center Seoul, | |
| Sanatorio Parque S.A. Rosario, | |
| Santa Casa de Misericordia de Porto Alegre Porto Alegre, | |
| Sendai Kousei Hospital Sendai-shi, Miyagi, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Shikoku Cancer Center Matsuyama, | |
| Shizuoka Cancer Center Shizuoka, | |
| Siriraj Hospital - Chulabhorn Bone Marrow Transplant Centre Bangkok, | |
| Songklanagarind Hospital Songkhla, | |
| Srinagarind Hospital Khon Kaen, | |
| St James University Hospital Leeds, | |
| St. Vincent's Hospital Gyeonggi-do, | |
| Summit Cancer Care PC Savannah, Georgia | |
| Sunshine Coast University Hospital Birtinya, | |
| Taipei Veterans General Hospital Taipei, | |
| Taylor Cancer Research Center Maumee, Ohio | |
| Tennessee Oncology Nashville, Tennessee | |
| Tennessee Oncology, PLLC - Chattanooga Chattanooga, Tennessee | |
| Texas Oncology - Northeast Texas Longview, Texas | |
| The Cancer Institute Hospital of JFCR Tokyo, | |
| The Christie NHS Foundation Trust Manchester, | |
| Theageneio Hospital Thessaloniki, | |
| Thoraxklinik Heidelberg gGmbH Heidelberg, | |
| Torbay Hospital Torquay, | |
| Tuen Mun Hospital Hong Kong, | |
| Turku Uni Central Hospital Turku, | |
| UC Health Oncology Research Colorado Springs, Colorado | |
| UCLA Hematology / Oncology Clinic Los Angeles, California | |
| UZ Antwerpen Edegem, | |
| UZ Brussel Jette, | |
| Uniklinik Schleswig-Holstein Kiel, | |
| Universitatsklinikum Essen Essen, | |
| Universitatsklinikum Regensburg Regensburg, | |
| Universitatsklinikum Schleswig-Holstein Lübeck, | |
| University Cancer & Blood Center, LLC Athens, Georgia | |
| University Hospital of Larissa Larissa, | |
| University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital Stoke-on-Trent, | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California, San Francisco San Francisco, California | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Miami Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| Universität Des Saarlandes Homburg, | |
| Universität Mannheim Mannheim, | |
| Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie Münster, | |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin, | |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii Gdansk, | |
| Uoa Sotiria Hospital Athens, | |
| VA Shreveport Healthcare System Shreveport, Louisiana | |
| VITAZ Sint-Niklaas, | |
| Vajira Hospital Bangkok, | |
| Velindre NHS Trust - Velindre Cancer Centre Cardiff, | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| Wakayama Medical University Hospital Wakayama, | |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie Olsztyn, | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Poznan, | |
| William Osler Health Centre - Brampton Civic Hospital Brampton, Ontario | |
| Yale Cancer Center New Haven, Connecticut | |
| ZAS Sint Augustinus Wilrijk Wilrijk, | |
| Ziekenhuis Rijnstate Arnhem, | |
| Ziekenhuis St. Jansdal Harderwijk, | |
| Zuckerberg San Francisco General Hospital San Francisco, California |
Sleep for Stroke Management and Recovery Trial (Sleep SMART)
Kayla Novitski, MPH, CCRP - kcgossel@med.umich.edu
NCT03812653
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Current Inclusion Criteria, as of 6/28/2024:
• Ischemic stroke within the prior 7 days.
• NIH Stroke Scale Score ≥1 at the time of enrollment Previous Inclusion Criteria, prior to 6/28/2024: 1\. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days. Exclusion Criteria (for entire time period):
• pre-event inability to perform all of own basic ADLs
• unable to obtain informed consent from subject or legally authorized representative
• incarcerated
• known pregnancy
• current mechanical ventilation (can enroll later if this resolves) or tracheostomy
• current use of positive airway pressure, or use within one month prior to stroke
• anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
• severe bullous lung disease
• history of prior spontaneous pneumothorax or current pneumothorax
• hypotension requiring current treatment with pressors (can enroll later if this resolves)
• other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
• massive epistaxis or previous history of massive epistaxis
• cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
• recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
• current receipt of oxygen supplementation \>4 liters per minute
• current contact, droplet, respiratory/airborne precautions
• Ischemic stroke within the prior 7 days.
• NIH Stroke Scale Score ≥1 at the time of enrollment Previous Inclusion Criteria, prior to 6/28/2024: 1\. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days. Exclusion Criteria (for entire time period):
• pre-event inability to perform all of own basic ADLs
• unable to obtain informed consent from subject or legally authorized representative
• incarcerated
• known pregnancy
• current mechanical ventilation (can enroll later if this resolves) or tracheostomy
• current use of positive airway pressure, or use within one month prior to stroke
• anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
• severe bullous lung disease
• history of prior spontaneous pneumothorax or current pneumothorax
• hypotension requiring current treatment with pressors (can enroll later if this resolves)
• other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
• massive epistaxis or previous history of massive epistaxis
• cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
• recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
• current receipt of oxygen supplementation \>4 liters per minute
• current contact, droplet, respiratory/airborne precautions
DEVICE: CPAP
Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
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Study Locations
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| Location | Contacts |
|---|---|
| Avera Research Institute Sioux Falls, South Dakota | Cassidy Kaiser - (Cassidy.Kaiser@avera.org) |
| Banner University Medical Center Phoenix Phoenix, Arizona | Karla Granados - (granados13@arizona.edu) |
| Banner- University Medical Center Tucson Tucson, Arizona | Baylee Reed - (bayleereed@arizona.edu) |
| Baptist Hospital of Miami Miami, Florida | |
| Barnes-Jewish Hospital St Louis, Missouri | Angela Wolford - (angelaw@wustl.edu) |
| Baylor Scott & White Institute of Rehabilitation Dallas, Texas | |
| Bellevue Hospital New York, New York | Lara Balick - (Lara.balick@nyulangone.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Elizabeth Heistand - (eheistan@bidmc.harvard.edu) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Lynn Perez - (lynn.perez@wmed.edu) |
| Brooks Rehabilitation Hospital Jacksonville, Florida | Taisiya Matev - (Taisiya.Matev@Brooksrehab.org) |
| Broward Health Fort Lauderdale, Florida | Laura Hudson - (lhudson@browardhealth.org) |
| Buffalo General Medical Center Buffalo, New York | Annemarie Crumlish - (ac35@buffalo.edu) |
| Carolinas Medical Center Atrium Health Charlotte, North Carolina | Maria Helms - (Anna.M.Helms@atriumhealth.org) |
| Carolinas Rehab Northeast Concord, North Carolina | Kiandra Austrie - (Kiandra.Austrie@atriumhealth.org) |
| Casa Colina Pomona, California | Jeanette Gumarang - (jgumarang@casacolina.org) |
| Cedars-Sinai Medical Center Los Angeles, California | Sung Min Na - (SungMin.Na@cshs.org;) |
| Chandler Regional Medical Center Chandler, Arizona | |
| Christ Hospital Cincinnati, Ohio | Ranjaka Gunawardena - (gunawad@ucmail.uc.edu) |
| Cleveland Clinic Cleveland, Ohio | |
| Cooperman Barnabas Medical Center West Orange, New Jersey | Jacob Huhn - (Jacob.Huhn@rwjbh.org) |
| Cox Medical Center Springfield, Missouri | Jessica Ratcliff - (jessica.ratcliff@coxhealth.com) |
| Dignity Health - St. Joseph's Hospital and Medical Center Phoenix, Arizona | Jaimi Jones - (jaimi.jones@commonspirit.org) |
| Doctors Medical Center of Modesto Modesto, California | Dharati Trivedi - (Dharati.trivedi@tenethealth.com) |
| Fort Sanders Regional Medical Center Knoxville, Tennessee | Allyson Holt - (aholt10@covhlth.com) |
| Geisinger Clinic Danville, Pennsylvania | |
| George Washington University Hospital Washington D.C., District of Columbia | |
| Grady Memorial Hospital Delaware, Ohio | Alicia Moore - (alicia.escobar.moore@emory.edu) |
| Greenville Memorial Hospital Greenville, South Carolina | Reilly Leonard - (Reilly.Leonard@PrismaHealth.org) |
| Guilford Neurologic Associates, Inc Greensboro, North Carolina | Jamil Admed - (jamil.ahmed@gnr.clinic) |
| Gundersen Lutheran Medical Foundation La Crosse, Wisconsin | |
| Hackensack Meridian Jersey Shore University Medical Center Neptune City, New Jersey | Abimbola Coker - (abimbola.coker@hmhn.org) |
| Harborview Medical Center Seattle, Washington | Belqeis Abatiyow - (babatiyo@uw.edu) |
| Hartford Hospital Hartford, Connecticut | Laura Grenier - (laura.grenier@hhchealth.org) |
| Henry Ford Hospital Detroit, Michigan | Teresa Long - (TWIEGAN1@hfhs.org) |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | Nichole Gallatti - (Nichole.gallatti@uphs.upenn.edu) |
| Inova Fairfax Falls Church, Virginia | |
| Intermountain Medical Center Murray, Utah | Nic Unsworth - (Nic.Unsworth@imail.org) |
| Iowa Methodist Des Moines, Iowa | Heather Shaull - (Heather.Shaull@unitypoint.org) |
| JFK Neuroscience Institute Edison, New Jersey | Surekha Patel - (surekha.patel@hmhn.org) |
| Jackson Memorial Hospital Miami, Florida | Andrea Escobar - (a.escobar1@med.miami.edu) |
| John Muir Medical Center- Walnut Creek Campus Walnut Creek, California | |
| Kaiser Permanente Los Angeles Los Angeles, California | Fatima Rodriguez - (Fatima.E.Rodriguez@kp.org) |
| Kaiser Redwood Redwood City, California | Quyen Chau - (Quyen.x.chau@kp.org) |
| Maimonides Medical Center Brooklyn, New York | Maryna Mootoo - (mmootoo@maimonidesmed.org) |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Saint Marys Campus Rochester, Minnesota | Amy Headlee - (Headlee.Amy@mayo.edu) |
| McLaren Flint Flint, Michigan | Kiona Graham - (kiona.graham@mclaren.org) |
| Memorial Hermann Texas Medical Center Houston, Texas | Ariana Hernandez - (Ariana.Victoria.AquinoHernandez@uth.tmc.edu) |
| Memorial Medical Center Modesto, California | |
| Mercy San Juan Medical Center Carmichael, California | |
| Methodist University Memphis, Tennessee | Quentin Thacker - (qthacker@uthsc.edu) |
| Montefiore Medical Center The Bronx, New York | |
| Morton Plant Hospital Clearwater, Florida | Rachel Widener - (Rachel.Widener@BAYCARE.ORG) |
| NYP Columbia University Medical Center New York, New York | Angela Velazquez - (agv2113@columbia.edu) |
| NYU Langone -Tish Hospital Medical Center New York, New York | Maria Cotrina - (Maria.Cotrina@nyulangone.org) |
| NYU Langone Brooklyn Brooklyn, New York | Maria Cotrina - (Maria.Cotrina@nyulangone.org) |
| North Shore University Hospital Manhasset, New York | Siddharth Dholiya - (sdholiya@northwell.edu) |
| Norton Healthcare Louisville, Kentucky | Trina Deforrest - (Trina.DeForrest@nortonhealthcare.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | |
| OSU Wexner Medical Center Columbus, Ohio | Luke Herren - (Luke.Herren@osumc.edu) |
| Ochsner Medical Center - Main Campus New Orleans, Louisiana | |
| Olive View- UCLA Medical Center Sylmar, California | |
| Orange County Global Medical Center Santa Ana, California | Natalia Dorantes - (Natalia.Dorantes@kpchealth.com) |
| Palmetto Health Richland Columbia, South Carolina | Georgia Taylor - (georgia.taylor@prismahealth.org) |
| Penn State Milton S. Hershey Center Hershey, Pennsylvania | Reba Chivari - (rchivari@pennstatehealth.psu.edu) |
| Providence St. Vincent Medical Center Portland, Oregon | Emily Lehman - (emily.lehman@providence.org) |
| Rancho Los Amigos National Rehabilitation Center Downey, California | |
| Ronald Reagan UCLA Medical Center Los Angeles, California | Sucheta Waghmare - (SWaghmare@mednet.ucla.edu) |
| Ruby Memorial Hospital Morgantown, West Virginia | Jay Sherman - (shermanj@wvumedicine.org) |
| Rush University Medical Center Chicago, Illinois | Henna McCoy - (Henna_R_McCoy@rush.edu) |
| SUNY Upstate Medical University Syracuse, New York | Lena Deb - (debl@upstate.edu) |
| Saint Cloud/Centracare Health Saint Cloud, Minnesota | Dawn Bauerly-Pieper - (dawn.bauerly-pieper@centracare.com) |
| Saint Luke's Hospital of Kansas City Kansas City, Missouri | Christine Kennish - (ckennish@saint-lukes.org) |
| Sarasota Memorial Hospital Sarasota, Florida | Flora Arevalo - (farevalo@intercoastalmedical.com) |
| Scripps Memorial La Jolla, California | Sandra Sanchez - (Sanchez.Sandra2@scrippshealth.org) |
| St. John Health System Tulsa, Oklahoma | Elvis Tamo - (elvis.tamo@ascension.org) |
| St. Joseph's Hospital Tampa, Florida | Kristen Grey - (kristin.grey@baycare.org) |
| St. Luke's University Hospital Bethlehem Campus Bethlehem, Pennsylvania | |
| St. Mary's Hospital and Medical Center Grand Junction, Colorado | Chelsea Lorimor - (Chelsea.Lorimor@imail.org) |
| Staten Island University Hospital Staten Island, New York | |
| Strong Memorial Hospital Rochester, New York | |
| TMC HealthCare Tucson, Arizona | |
| Tampa General Hospital Tampa, Florida | |
| Temple University Hospital Philadelphia, Pennsylvania | Sandra Combs - (Sandra.combs@tuhs.temple.edu) |
| The University of Vermont Medical Center Main Campus Burlington, Vermont | |
| Trinity Health Saint Mary's Grand Rapids, Michigan | Bill Boshoven - (Bill.Boshoven@trinity-health.org) |
| Tufts Medical Center Boston, Massachusetts | |
| UC Davis Medical Center Sacramento, California | Andrea Diaz Sevilla - (amdiazsevilla@ucdavis.edu) |
| UC Irvine Orange, California | Josue Prado - (josuep2@hs.uci.edu) |
| UCLA Kaiser Fontana Ontario, California | Kimberly Cortez - (Kimberly.X.Cortez@kp.org) |
| UCSD Health La Jolla La Jolla, California | Theresa McQuaid - (tmcquaid@ucsd.edu) |
| UCSD Medical Center - Hillcrest Hospital San Diego, California | Theresa McQuaid - (tmcquaid@ucsd.edu) |
| UCSF Helen Diller Medical Center at Parnassus Heights San Francisco, California | Eboni Bailey - (eboni.bailey@ucsf.edu) |
| UF Health Shands Hospital Gainesville, Florida | |
| UF Jacksonville Jacksonville, Florida | Yasmeen Shabbir - (Yasmeen.Shabbir@jax.ufl.edu) |
| UH Cleveland Medical Center Cleveland, Ohio | Mary Andrews - (Mary.Andrews@UHhospitals.org) |
| UMass Memorial Medical Center, Worcester, Massachusetts | Nimmy Francis - (Nimmy.RoseFrancis@umassmed.edu) |
| UPMC Presbyterian Hospital Pittsburgh, Pennsylvania | Jason Weimer - (weimerjm@upmc.edu) |
| UVA Medical Center Charlottesville, Virginia | Allison Ramsey - (agr5nj@uvahealth.org) |
| University Health Shreveport Shreveport, Louisiana | Chelsie Liegey - (chelsie.liegey@lsuhs.edu) |
| University of Alabama Hospital Birmingham, Alabama | Sarah Bruton - (sjbruton@uabmc.edu) |
| University of Chicago Chicago, Illinois | Samantha Jankowski - (sjankowski@bsd.uchicago.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Ranjaka Gunawardena - (gunawad@ucmail.uc.edu) |
| University of Illinois Hospital and Health Sciences System Chicago, Illinois | Lucia LeBlanc Perez - (lleblanc@uic.edu) |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | Heena Olalde - (heena-olalde@uiowa.edu) |
| University of Maryland Baltimore, Maryland | Beata Assadi - (bassadi@som.umaryland.edu) |
| University of Mississippi Medical Center Jackson, Mississippi | Joy Walker - (jwalker10@umc.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of New Mexico Hospital Albuquerque, New Mexico | |
| University of Utah Healthcare Salt Lake City, Utah | Annette Blackburn - (annette.blackburn@hsc.utah.edu) |
| University of Wisconsin University Hospital Madison, Wisconsin | Sima Sayyahmelli - (sayyahmelli@neurosurgery.wisc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Keila Najera - (keila.najera@vcuhealth.org) |
| Virginia Mason Medical Center Seattle, Washington | |
| Wake Forest University Baptist Medical Center Winston-Salem, North Carolina | Zachary Chandler - (zchandle@wakehealth.edu) |
| West Chester Hospital West Chester, Ohio | Ranjaka Gunawardena - (gunawad@ucmail.uc.edu) |
| Yale-New Haven Hospital New Haven, Connecticut | Radu Radulescu - (radu.radulescu@yale.edu) |
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
Olena Boyarska - olena.boyarska@seattlechildrens.org
NCT06504589
Show full eligibility criteria
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Consent
A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian
B. Is willing and able to adhere to the study visit schedule and other protocol requirements
Demographics
A. ≥ 12 years of age at Visit 1
Medical History
A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period
Disease History
A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
* Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
* Two well-characterized disease-causing pathogenic variants in the CFTR gene
or
* One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators
B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1
C. Does not have a history of lung transplantation
Concomitant Medications
A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period
B. No use of an investigational drug within 90 days prior to and including Visit 1
C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed.
D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
Cystic Fibrosis
ineligible and/or not taking CFTR modulators, People with CF
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Show 68 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adult Cystic Fibrosis Center at the University of Utah Salt Lake City, Utah | Kristyn Packer - (kristyn.packer@hsc.utah.edu) |
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | Anna Pippins - (apippins@wakehealth.edu) |
| Augusta University Augusta, Georgia | Heidi Stapp - (hstapp@augusta.edu) |
| Baylor College of Medicine Houston, Texas | Tracy Mosely - (tlmosely@texaschildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| Central Florida Pulmonary Group Altamonte Springs, Florida | Desiree Serr - (dserr@cfpulmonary.com) |
| Children's Healthcare of Atlanta and Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Children's Hospital Colorado Aurora, Colorado | Mary Cross - (mary.cross@childrenscolorado.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Erin Donnelly - (Donnellye4@email.chop.edu) |
| Childrens Hospital Los Angeles Los Angeles, California | Carmen Reyes - (mareyes@chla.usc.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cleveland Clinic Cystic Fibrosis Program Cleveland, Ohio | Dave Weaver - (weaverd@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde Park, New York | Susan Galvin - (sgalvin@northwell.edu) |
| Columbia University Cystic Fibrosis Program New York, New York | Emily DiMango - (ead3@cumc.columbia.edu) |
| Cook Children's Medical Center Fort Worth, Texas | Anna Reyes - (anna.reyes@cookchildrens.org) |
| Corewell Health Helen DeVos Grand Rapids, Michigan | Alicia Castillo Bahena - (alicia.castillobahena@corewellhealth.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Kristina "Tina" Adrean - (Kadrean@ascension.org) |
| Hershey Medical Center Pennsylvania State University Hershey, Pennsylvania | Diane M Kitch - (dkitch@pennstatehealth.psu.edu) |
| Inova L.J. Murphy Pediatric CF Program Fairfax, Virginia | Colleen Mann - (colleen.mann@inova.org) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Margot Hardcastle - (mhardcastle@mgh.harvard.edu) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| National Jewish Health Denver, Colorado | Alix Wilson - (wilsona@njhealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| Oregon Health & Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Natalia Argel - (Nargel@phoenixchildrens.com) |
| Prisma Health Children's Hospital - Midlands Columbia, South Carolina | Veronica Lipscomb - (Veronica.Lipscomb@PrismaHealth.org) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| Stanford University Medical Center Palo Alto, California | Jacquelyn Spano - (jmzirbes@stanford.edu) |
| Tampa General Hospital Tampa, Florida | Andrew Marino - (armarino@usf.edu) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Kathryn Monroe - (kathrynmonroe@uabmc.edu) |
| The Cystic Fibrosis Center of Western New York Buffalo, New York | Julianne Hergenroder - (jhergenroder@upa.chob.edu) |
| The Minnesota Cystic Fibrosis Center Minneapolis, Minnesota | CF Trials Contact University of Minnesota, Participant Contact - (cftrials@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| Tulane University New Orleans, Louisiana | Adrienne Savant - (asavant1@tulane.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | Kathleen Hicks - (HicksKathleenT@uams.edu) |
| University of California San Diego San Diego, California | Jenna Mielke - (jmielke@health.ucsd.edu) |
| University of California, San Francisco - Adult Center San Francisco, California | Courtney Moreno - (Courtney.Moreno@ucsf.edu) |
| University of California, San Francisco - Peds Center San Francisco, California | Ngoc Ly - (Ngoc.Ly@ucsf.edu) |
| University of Florida Gainesville, Florida | Chrystal Bailey - (Cbailey1@peds.ufl.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Kentucky Lexington, Kentucky | Chase Whitaker - (chase.whitaker@uky.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber (Ivan) Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Michel Veit - (michel.veit@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Julie Goudy - (julie_goudy@med.unc.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco - (adrienne.dericco2@upmc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barb Johnson - (Barbara_Johnson@URMC.Rochester.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Keianna Brown - (Keianna.brown@utsouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt University Medical Center Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| Wayne State University Harper University Hospital Detroit, Michigan | Debra Driscoll - (ddriscol@med.wayne.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06731413
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Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
* Stage IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
* Age 70 or meeting frailty definition or above at the date of signing informed consent
* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy
* PD-L1 tumor proportion score (TPS) of less than 50%
* Eastern Cooperative Oncology Group (ECOG) PS of 0-3
* Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
* Absolute neutrophil count (ANC) ≥ 1,000/μL
* Platelets ≥ 75,000/μL
* Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants with life expectancy of less than 3 months at the time of enrollment
* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
* Diagnosis of interstitial lung disease
* Creatinine clearance of \<30 mL/min
* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
* Doses less than or equal to the equivalent of prednisone 10 mg daily
* Short courses of steroids that are discontinued prior to enrollment
* Inhaled, intranasal and/or topical steroids
* Dexamethasone taper for treating vasogenic edema associated with CNS disease DRUG: Reduced Dose of Chemotherapy and Immunotherapy
Non-small Cell Lung Cancer, NSCLC, Advanced Non-small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer, NSCLC
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey Lung Team - (masseylung@vcu.edu) |
Health Education Approach to Lung Screening (HEALS)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06070870
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Inclusion Criteria:
* Meets current USPSTF guidelines for lung cancer screening (LCS)
* 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.
One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.
* Currently smokes or has quit smoking within the past 15 years
* Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
* Willing to complete all navigation-related study activities
* Able to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
* Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
* Has undergone a previous lung cancer screening
* Inability to speak English
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements BEHAVIORAL: Patient Navigation
Lung Cancer
Lung cancer, Screening
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Study Locations
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| Location | Contacts |
|---|---|
| Medical University of South Carolina Charleston, South Carolina | Ellen Gomez, MA - (gomezel@musc.edu) |
| University of North Carolina-Chapel Hill Carrboro, North Carolina | Christopher Lyu, MPA - (Christopher_Lyu@med.unc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Massey CPC Team - (MasseyCPC@vcu.edu) |
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)
Rachael Buckingham, BS - Rachael.buckingham@seattlechildrens.org
NCT05548283
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Inclusion Criteria:
* All genders ≥ 6 years of age at Visit 1
* Documentation of a CF diagnosis
* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
* At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
* Participant is not pregnant
* No known renal impairment or history of solid organ transplantation
* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1 DRUG: Beta-lactam antibiotic, DRUG: Aminoglycoside
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
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Study Locations
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| Location | Contacts |
|---|---|
| All Children's Hospital St. Petersburg, Florida | Diana Hodge - (dhodge6@jhmi.edu) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Yung Hsuan (Irene) Wu - (yhwu@luriechildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital, Brigham & Women's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| CHOC Children's Hospital Orange, California | Lila Klein - (Lila.klein@choc.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Michelle Parrish - (MParrish@akronchildrens.org) |
| Children's Hospital of New York New York, New York | Hossein Sadeghi - (HS762@cumc.Columbia.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Elizabeth Hartigan - (elizabeth.hartigan@chp.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Jack Serio - (jserio@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cook Children's Medical Center Fort Worth, Texas | Jill Finto - (jill.finto@cookchildrens.org) |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | Barbara A Rodgers - (Barbara.A.Rodgers@hitchcock.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Andrew James - (andrew.james@corewellhealth.org) |
| Indiana University Medical Center Indianapolis, Indiana | Lisa Bendy - (lbendy@iu.edu) |
| Joe DiMaggio Children's Hospital Hollywood, Florida | Norma (Jean) Barton - (nbarton@mhs.net) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Lenox Hill Hospital Cystic Fibrosis Center New York, New York | Teresa Demarco - (Tdemarco3@northwell.edu) |
| Long Beach Memorial Medical Center Long Beach, California | Marylee Melendrez - (mmelendrez@memorialcare.org) |
| Maine Medical Center Scarborough, Maine | Harmony Renna - (Harmony.Renna@mainehealth.org) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| Nemours Children's Clinic Jacksonville, Florida | Jennifer (Jenn) Gafford - (Jennifer.gafford@nemours.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Ashley Scott - (Ashley.Scott@osfhealthcare.org) |
| Oklahoma Cystic Fibrosis Center Oklahoma City, Oklahoma | CF Center Participant Contact - (cfresearchteam@ouhsc.edu) |
| Oregon Health Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Rutgers - Robert Wood Johnson Medical School New Brunswick, New Jersey | Sheila Redding, Sheila - (sr1238@rwjms.rutgers.edu) |
| SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri | Freda Branch - (freda.branch@health.slu.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Heather Hathorne - (hyhathorne@uabmc.edu) |
| Toledo Children's Hospital Toledo, Ohio | Kelly Hoot - (kelly.hoot@promedica.org) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB) Calgary, Alberta | Clare Smith - (Clare.smith@albertahealthservices.ca) |
| University of California San Diego San Diego, California | Jenna Mielke, - (jmielke@health.ucsd.edu) |
| University of California at Davis Medical Center Sacramento, California | Daniel Diaz-Vigil - (ddiazvigil@ucdavis.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Nicole Hummel - (Nicole.Hummel@UCHealth.com) |
| University of Florida Gainesville, Florida | Melissa Lingis - (melissa.lingis@peds.ufl.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Louisville Louisville, Kentucky | Melissa Thomas - (mcthom12@louisville.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Mary Klosterman - (Mary.Klosterman@UTSouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
Pulmonary Hypertension Association Registry (PHAR)
Elizabeth Joseloff, PhD - PHAR@PHAssociation.org
NCT04071327
Show full eligibility criteria
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Inclusion Criteria:
* All age groups
* Written informed consent
* Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
* Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:
* Diagnosis of WSPH Group 2 pulmonary hypertension
* Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
* Diagnosis of WSPH Group 5 pulmonary hypertension Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
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Show 52 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | Amresh Raina, MD - (amresh.raina@ahn.org) Kimberly Curry, RN - (kimberly.curry@ahn.org) |
| AnMed Health Anderson, South Carolina | Abhijit Raval, MD - (drravallung@gmail.com) Kelly Dickson, RRT - (kelly.dickson@anmedhealth.org) |
| Arizona Pulmonary Specialists, Ltd. Phoenix, Arizona | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | Michelle Cicona - (michelle.cicona@aurora.org) |
| Baylor Scott & White Plano, Texas | Sahil Bakshi, MD - (sahil.bakshi@bswhealth.org) Lucy Knight - (lucy.knight@bswhealth.org) |
| Children's Hospital Colorado Aurora, Colorado | Dunbar Ivy, MD - (dunbar.ivy@childrenscolorado.org) Kathleen Miller-Reed - (kathleen.miller-reed@childrenscolorado.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Russel Hirsch, MD - (russel.hirsch@cchmc.org) Alyssa Rhode, BS - (alyssa.rhode@cchmc.org) |
| Columbia University Medical Center/NewYork-Presbyterian Hospital New York, New York | Erika S. Berman Rosenzweig, MD - (esb14@cumc.columbia.edu) Daniela Brady, FNP - (dm2069@cumc.columbia.edu) |
| Cottage Health System - Santa Barbara Pulmonary Associates Santa Barbara, California | Jeffrey S. Sager, MD, MS - (jsager@sblung.com) Caitlin Torchia, RN - (ctorchia@sbch.org) |
| Duke University Medical Center Durham, North Carolina | Kishan Parikh, MD - (kishan.parikh@duke.edu) Noely Martinez-Overby, CMA - (noely.martinez-overby@duke.edu) |
| Froedtert & Medical College of Wisconsin Milwaukee, Wisconsin | Kenneth W. Presberg, MD - (kpresber@mcw.edu) Amy Kimber, APNP - (akimber@mcw.edu) |
| Ft. Sanders Regional Medical Center Knoxville, Tennessee | Regina Overton-Barnes, APN - (rbarnes@statcaremed.net) |
| Henry Ford Hospital Detroit, Michigan | Rana L. Awdish, MD - (rawdish1@hfhs.org) Sheri Renaud, RN - (srenaud9@hfhs.org) |
| Indiana University Health Indianapolis, Indiana | Michael Duncan, MD - (mduncan3@iuhealth.org) Melissa Astin, BSN - (mastin@iuhealth.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Oksana A. Shlobin, MD - (oksana.shlobin@inova.org) Edwinia Battle, BSN, CCRC - (edwinia.battle@inova.org) |
| Johns Hopkins University Baltimore, Maryland | Stephen C. Mathai, MD, MHS - (smathai4@jhmi.edu) Julie Shamberger, RN - (jshambe2@jhmi.edu) |
| KU Medical Center Kansas City, Kansas | Timothy Williamson, MD - (twillia1@kumc.edu) |
| Kentuckiana Pulmonary Associates Louisville, Kentucky | |
| LSU Healthcare Network Clinic New Orleans, Louisiana | Matthew Lammi, MD - (mlammi@lsuhsc.edu) Paula Lauto, RN - (plauto@lsuhsc.edu) |
| Mayo Clinic Rochester, Minnesota | Robert P. Frantz, MD - (frantz.robert@mayo.edu) |
| Mayo Clinic Florida Jacksonville, Florida | Charles D. Burger - (burger.charles@mayo.edu) Kristine Gundian, CRC - (gundian.kristine@mayo.edu) |
| Northside Hospital Atlanta, Georgia | Paul Boyce, MD, MPH - (paul.boyce@northside.com) Tamara Wakhisi - (tamara.wakhisi@northside.com) |
| Ochsner Medical Center New Orleans, Louisiana | Stacy Mandras, MD - (smandras@ochsner.org) Angela Penning - (angela.penning@ochsner.org) |
| Rhode Island Hospital Providence, Rhode Island | Corey E. Ventetuolo, MD, MS - (corey_ventetuolo@brown.edu) Amy Palmisciano, BSN - (apalmisciano@lifespan.org) |
| Seattle Children's Hospital Seattle, Washington | Delphine Yung, MD - (delphine.yung@seattlechildrens.org) Anne Davis, RN - (anne.davis@seattlechildrens.org) |
| Sentara Heart Hospital Norfolk, Virginia | Melinda Bullivant, MSN, RN, CCRC - (mmbulliv@sentara.com) |
| Stanford University Palo Alto, California | Doris Stanley, BS - (dstandley@stanford.edu) Patricia Del Rosario, RN - (pdelrosa@stanford.edu) |
| Texas Children's Hospital Houston, Texas | Nidhy Varghese, MD - (npvarghe@texaschildrens.com) Elise Whalen, MSN - (ecbockov@texaschildrens.com) |
| The Oregon Clinic Portland, Oregon | Jeffrey C. Robinson, MD - (jerobinson@orclinic.com) Stephanie Persons, BS - (spersons@orclinic.com) |
| UC Davis Health Sacramento, California | Nikhil Jaha - (nkjaha@ucdavis.edu) Cynthia Perry-Baker - (clpbaker@ucdavis.edu) |
| UC Health Cincinnati, Ohio | Jean M. Elwing, MD - (elwingj@ucmail.uc.edu) Jennifer Gilkison, RN, BSN - (gilkisjr@ucmail.uc.edu) |
| UC Health - Anschutz Medical Campus Aurora, Colorado | David Badesch, MD - (david.badesch@cuanschutz.edu) Kelly Hannon, RN - (kelly.hannon@cuanschutz.edu) |
| UCSF Benioff Children's Hospital San Francisco, California | Jeffrey Fineman, MD - (jeff.fineman@ucsf.edu) Jasmine Becerra - (jasmine.becerra@ucsf.edu) |
| UCSF Medical Center San Francisco, California | Teresa De Marco, MD - (teresa.demarco@ucsf.edu) Amanda Schnell Heringer, RN, CNS - (amanda.schnellheringer@ucsf.edu) |
| UNC Chapel Hill Chapel Hill, North Carolina | H. James Ford, MD - (hjford@med.unc.edu) Laura Nowicki, RN - (laura_nowicki@med.unc.edu) |
| UT Southwestern Medical Center Dallas, Texas | Sonja D. Bartolome, MD - (sonja.bartolome@utsouthwestern.edu) Balaji Kolasani - (balaji.kolasani@utsouthwestern.edu) |
| University of Connecticut Health Farmington, Connecticut | Raymond Foley, DO - (r.foley@uchc.edu) |
| University of Iowa Hospitals & Clinic Iowa City, Iowa | |
| University of MD Medical Group, PA Baltimore, Maryland | Gautam V. Ramani, MD - (gramani@som.umaryland.edu) Lioubov Poliokova - (lpoliako@som.umaryland.edu) |
| University of Minnesota Health Minneapolis, Minnesota | Thenappan Thenappan, MD - (tthenapp@umn.edu) Gretchen Piechel - (gpeichel@umn.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Steven M. Kawut, MD, MS - (kawut@upenn.edu) Randi Goodman - (randi.goodman@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Marc A. Simon, MD, MS - (simonma@upmc.edu) Abby Sung - (sunga3@upmc.edu) |
| University of Rochester Medical Center Rochester, New York | R. James White, MD, PhD - (jim_white@urmc.rochester.edu) Allison Light-Mills, PhD - (allison_light@urmc.rochester.edu) |
| University of Utah Health Salt Lake City, Utah | John J. Ryan, MD - (john.ryan@hsc.utah.edu) Brittany Penn - (brittany.penn@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Sula Mazimba, MD - (sm8sd@hscmail.mcc.virginia.edu) Allison Raymond, RN, CCRC - (AEH4M@hscmail.mcc.virginia.edu) |
| University of Washington Seattle, Washington | Peter Leary, MD, PhD - (learyp@uw.edu) Genecelle Delossantos - (gen7@medicine.washington.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | James R. Runo, MD - (jrr@medicine.wisc.edu) Amy Chybowski, NP - (amy.chybowski@uwmf.wisc.edu) |
| VCU Medical Center Richmond, Virginia | Daniel Grinnan, MD - (daniel.grinnan@vcuhealth.org) Charnetta Lester - (charnetta.robinson@vcuhealth.org) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Eric D. Austin, MD, MSc - (eric.austin@vumc.org) Karen Chaffin, NP - (karen.e.chaffin@vumc.org) |
| Vanderbilt University Medical Center Nashville, Tennessee | Anna R. Hemnes, MD - (anna.r.hemnes@vumc.org) |
| Washington University in St. Louis St Louis, Missouri | Murali M. Chakinala, MD - (chakinalam@wustl.edu) Ellen Newton-Lovato, RN - (elovato@wustl.edu) |
| Weill Cornell Medical Center New York, New York | Evelyn M. Horn, MD - (horneve@med.cornell.edu) Rosemarie Gadioma - (gadioma@nyp.org) |
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial (DIVA)
Elizabeth Foglia - FOGLIA@email.chop.edu
NCT05446272
Show full eligibility criteria
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Inclusion Criteria:
* Gestational age of 23 0/7- 28 6/7 weeks at birth
* Intubated in the first 7 days of life
* Undergoing extubation following at least 12 hours of invasive mechanical ventilation
* Post-natal age \<32 weeks Post menstrual age at time of extubation
Exclusion Criteria:
* Major congenital anomalies, including pulmonary hypoplasia
* Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
* Esophageal bleeding or other contraindication to NG/OG catheter placement
* Current weight \<500 grams (based on Edi catheter approval)
* Study ventilator not available at time eligibility criteria are met
* Planned surgery or invasive procedure within 5 days of extubation
* Informed consent not provided DEVICE: NIV-NAVA, DEVICE: NS-NIPPV
Extubation Failure, Bronchopulmonary Dysplasia, Death
I'm interested
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Show 20 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando, Florida | Samarth Shukla - (Samarth.Shukla.MD@AdventHealth.com) |
| Arkansas Children's Hospital Little Rock, Arkansas | David Matlock - (DMatlock@uams.edu) |
| Atrial Health Brenner Children's Hospital( Wake Forest) Winston-Salem, North Carolina | Ricardo J Rodriguez - (rjrodrig@wakehealth.edu) |
| BC Children's and Women's Hospital Vancouver, | Jonathan Wong - (jonathan.wong@cw.bc.ca) |
| Children's Hospital of Richmond Richmond, Virginia | Karen Hendrick-Munoz - (karen.hendricks-munoz@vcuhealth.org) |
| Children's Mercy Hospital Kansas City, Missouri | Christopher Nitkin - (crnitkin@cmh.edu) |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | Elizabeth Foglia - (FOGLIA@email.chop.edu) |
| Intermountain Medical Center Murray, Utah | Bradley Yoder - (Bradley.Yoder@hsc.utah.edu) |
| Joe DiMaggio Children's Hospital Hollywood, Florida | Bruce Shulman - (brucesmd@icloud.com) |
| Levine Children's Hospital Charlotte, North Carolina | Eugenia Pallotto - (Eugenia.Pallotto@atriumhealth.org) |
| Loma Linda University Loma Linda, California | |
| Mt Sinai Hospital Toronto, | Amish Jain - (Amish.Jain@sinaihealth.ca) |
| Nationwide Children's Hospital Columbus, Ohio | - (Matthew.Kielt@nationwidechildrens.org) |
| Norton Children's Hospital Louisville, Kentucky | Dan Stewart - (dan.stewart@louisville.edu) |
| Peyton Manning Children's Hospital Indianapolis, Indiana | Markus Tauscher - (mktausc1@ascension.org) |
| Sharp Mary Birch San Diego, California | Anup Katheria - (Anup.Katheria@sharp.com) |
| Sunnybrook Health Sciences Centre Toronto, Ontario | Maher Shahroor - (maher.shahroor@sunnybrook.ca) |
| Utah Valley Hospital Provo, Utah | - (Bradley.Yoder@hsc.utah.edu) |
| Virtua Vorhees Hospital Voorhees Township, New Jersey | - (ghavams@chop.edu) |
| Washington University in St.Louis St Louis, Missouri | - (rao_r@wustl.edu) |