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483 Study Matches

Endocardial Mapping With the CoreMap EP Mapping System (INvENI)

Jim Foster, SysEng - jfoster@coremapmedical.com

NCT06529978
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Inclusion Criteria:

• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures
Exclusion Criteria:

• Any of the following within three months of enrollment:
• Myocardial infarction (MI)
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Confirmed thrombus on imaging
• Any of the following within six months of enrollment:
• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke)
• Any of the following cardiac conditions:
• New York Heart Association (NYHA) IV
• Left ventricular ejection fraction (LVEF) \< 30%
• Left atrial diameter \>55mm (anterioposterior) (Phase 3)
• Carotid stenting or endarterectomy
• Atrial or ventricular septal closure or left atrial appendage closure
• Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Unstable angina
• Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
• Moderate to severe mitral valve stenosis or other severe valvular disease
• Any blood clotting or bleeding abnormalities
• Contraindication to systemic anticoagulation
• AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• Body mass index (BMI) \> 40 kg/m2
• Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• Renal failure requiring dialysis or transplant
• Acute illness, active systemic infection, or sepsis
• Active drug or alcohol dependency
• Hypertrophic cardiomyopathy or cardiac amyloidosis
• Cor pulmonale
• Any contra-indication that may extend procedure time, at the discretion of the operator
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Subject considered part of vulnerable population
• Life expectancy less than one year
• Employee of the study site or Sponsor
• Subjects who are currently enrolled in another study that would directly interfere with this study
DEVICE: CoreMap EP Mapping System Mapping, DEVICE: CoreMap EP Mapping System Map-Guided Ablation
Persistent Atrial Fibrillation
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Location Contacts
NCH Downtown Baker Hospital Naples, Florida
Na Homolce Hospital Praha Klanovice,
University of Vermont Medical Center Burlington, Vermont
Virginia Commonwealth University (VCU) Richmond, Virginia

Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts

Massey CTO CPC Team - MasseyCPC@vcu.edu

NCT07706192
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Inclusion Criteria:
* Adult patients (≥18 years old) with a current diagnosis of cancer * Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center * Patients who are willing to participate and provide informed consent * Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions
Exclusion Criteria:
* Patients who are unable to provide informed consent due to cognitive impairment or language barriers * Patients who are enrolled in other clinical trials that prohibit participation in additional research * Patients who do not consent to being included in the food insecurity registry * Patients with medical conditions other than cancer
OTHER: Food Assistance Program, OTHER: Standard of Care
Treatment Adherence
Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment
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Virginia Commonwealth University Richmond, Virginia Massey CTO CPC Team - (MasseyCPC@vcu.edu)

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

Dyne Clinical Trials - clinicaltrials@dyne-tx.com

NCT07486934
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Inclusion Criteria:
* Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are acceptable. * Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the ankle are allowed). * Body mass index (BMI) less than (\<) 35 kilograms per meter square (kg/m\^2).
Exclusion Criteria:
* A known diagnosis of congenital DM1. * History of major surgical procedure (based on Investigator judgment) within 12 weeks prior to the start of screening, with the exception of implanted pacemaker or defibrillator. * Use of glucagon-like peptide 1 (GLP-1) agonist/incretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments. Note: Other inclusion and exclusion criteria may apply.
DRUG: zeleciment basivarsen (DYNE-101), DRUG: Placebo
Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert
DM1, Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonia, Myotonic Dystrophy Type 1 (DM1), Dystrophy Myotonic, Myotonic Disorders, Steinert Disease, Steinert, Myotonic Muscular Dystrophy, HARMONIA, Dyne Therapeutics, Dyne, DYNE-101, zeleciment basivarsen, z-basivarsen
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Study Locations

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Location Contacts
CHU de Nantes - Hôtel-Dieu Nantes, Yann Pereon - (yann.pereon@univ-nantes.fr)
CHU de Toulouse - Hôpital Pierre-Paul Riquet Toulouse, Antoine Faurie-Grépon - (antoine.faurie-grepon@inserm.fr)
Centro Clinico Nemo Milano, Fondazione Serena ETS Milan, Milano Erica Di Natale - (erica.dinatale@centrocliniconemo.it)
Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit Berlin, State of Berlin Elisabetta Gazzerro, Dr med - (Elisabetta.gazzerro@charite.de)
Hospital Universitario Infanta Sofía San Sebastián de los Reyes, Madrid Gerardo Gutierrez Gutierrez - (g3.neuro@gmail.com)
IU Health Neuroscience Center Indianapolis, Indiana Jennifer Terrell - (jkramey@iu.edu)
LMU Klinikum der Universität München Neurologische Klinik und Poliklinik Friedrich-Baur-Institut Campus Innenstadt Munich, Bavaria Riccardo Morbio - (Riccardo.Morbio@med.uni-muenchen.de)
National Hospital Organization Osaka Toneyama Medical Center Toyonaka-Shi, Osaka Tsuyoshi Matsumura, MD, PhD - (matsumura.tsuyoshi.kq@mail.hosp.go.jp)
Pitié-Salpêtrière Hospital Paris, Nassima Ait Tahar - (n.ait-tahar@institut-myologie.org)
Rare Disease Research, LLC Hillsborough, North Carolina Julia Zhu - (julia.zhu@rarediseaseresearch.com)
Rare Disease Research, LLC Hillsborough, North Carolina Hannah Nation - (hannah.nation@rarediseaseresearch.com)
Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 8077) Copenhagen, Nicolai Rasmus Preisler - (nicolai.rasmus.preisler@regionh.dk)
Roy Blunt NextGen Precision Health Institute Columbia, Missouri Heather McHatton - (heathermchatton@health.missouri.edu)
The University of Texas Health Science Center at San Antonio San Antonio, Texas Randee Kent - (kentbaron@uthscsa.edu)
UCSD - Altman Clinical and Translational Research Institute La Jolla, California Christian Farfan - (cfarfan@health.ucsd.edu)
UZ Leuven Leuven, Britt Van Lancker - (britt.vanlancker@uzleuven.be)
University College London Hospitals NHS Foundation Trust National Hospital for Neurology and Neurosurgery London, England Vino Vivekanandam, PhD - (v.vivekanandam@ucl.ac.uk)
Virginia Commonwealth University - Biotech One Richmond, Virginia Levi Headrick - (levi.headrick@vcuhealth.org)
Yamaguchi University Hospital Ube-Shi, Yamaguchi Masayuki Nakamori, MD, PhD, Professor - (mnakamor@yamaguchi-u.ac.jp)