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Offering hope and changing lives
Clinical research helps us identify new therapeutic options that make our lives healthier and safer. Novel therapies are scrutinized through the clinical trial process prior to receiving FDA approval to confirm their safety, effectiveness, and quality before getting approved for public use. Through our innovative clinical research studies, we gain insights and answers to advance new preventions, treatments, and sometimes cures. We serve as a gateway for researchers to advance science and clinical knowledge. Our basic, clinical, and translational research brings the most advanced care to our patients and community.
Clinical research is a vital component to caring for our community. Our culture promotes innovation and collaboration with academic, industry, government, and philanthropic partners. Research is the intersection of hope, innovation, and science.
Adult research and clinical trials
Cardiovascular
Electrophysiology (heart rhythm disorders)
- Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
- REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation
- WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Alternative Post-Implant Monotherapy: SIMPLAAFY
Cardiothoracic surgery and vascular
- Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
- Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta (ARISE II)
- ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES (SOCRATES)
- IMPRoving Outcomes in Vascular DisEase- Aortic Dissection (IMPROVE-AD)
- AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
- Medtronic Evaluation of the Safety and Performance of The Medtronic Intrepid Transcatheter Tricuspid Valve Replacement System with Transfemoral access in Patients with symptomatic severe tricuspid regurgitation - TTVR EFS TF
- RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE)
Heart transplant
Structural heart
- Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. (APOLLO)
- Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study
- Clinical trial of Atrial Fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants.
Heart failure
Interventional (cooronary artery disease)
- A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease: Prevail Global
- Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol: ECP CAP
Bone marrow transplant
- CIBMTR: Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries
- 10-CBA: A multicenter access and distribution protocol for unlicensed cyropreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
- NCBP: A Multicenter Safety Study of Unlicensed, Investigational Cyropreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
- Kymriah: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release
- Allo-T-DART: A Phase 1 Trial of Targeted Immunotherapy with Daratumumab following myeloablative Total Body Irradiation (TBI)-Based Conditioning and Allogeneic Hematopoietic Cell Transplantation in Children, Adolescents, and Young Adults with High-Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (T-ALL/T-LLy) (ALLO-T-DART)
- Foresight: Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commerically Available Immunotherapy
- NK T Cell - Pilot Study using Induction Chemo-Immunotherapy Followed by Consolidation with Reduced Toxicity Conditioning and Allogeneic Stem Cell Transplant in Advanced Stage Mature Non-Anaplastic T- or NK-cell Lymphoma/Leukemia in Children, Adolescents, and Young Adults
Digestive health
Colorectal
- A Phase 1b-2, Multicenter Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP)
Randomized trial of Intra-Corporeal Anastomosis for RighT colectomies (RICART study)
Gastrointestinal
- Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic (Pro-Biotic) to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis (IPAA)
- A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis
General surgery
- Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair (Hernia Sac)
Neuroscience
Stroke
- Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials (VERIFY)
- Distal Ischemic Stroke Treatment with Adjustable Low-profile Stentriever (DISTALS)
DMD
- CureDuchenne Link: A Resource to Support Research Studies in Duchenne and Becker Muscular Dystrophy (DMD/BMD)
SMA
- Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE (PIERRE) Trial
- An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered via the ThecaFlex DRx™ System (PIERRE-PK)
Oncology & hematology
Medical oncology – solid tumors
- y-mAbs 1001: Phase 1 Trial with GD2-SADA: 177-Lu-DOTA Drug Complex in Patients with Recurrent or Refractory metastatic solid tumors known to express GD2, including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma, and Malignant Melanoma
- LIGHTBEAM 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilvertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors
Pulmonary & pulmonary diseases
Cystic fibrosis
- Standardizing Treatments for Pulmonary Exacerbations: A Platform for evaluating treatment decisions to improve outcomes (STOP360)
- A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators (REACH)
- CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes (CHEC)
Lung transplant
- Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial)
- SAFETY OF 10°C PROLONGED LUNG PRESERVATION VS. STANDARD OF CARE
- ROCKaspire
Adult pulmonary diseases
- I-SPY COVID Trial – An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients
- A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of TOZORAKIMAB in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA)
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
- A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
- A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Pediatric research and clinical trials
Bone marrow transplant
- CIBMTR: Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries
- 10-CBA: A multicenter access and distribution protocol for unlicensed cyropreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
- NCBP: A Multicenter Safety Study of Unlicensed, Investigational Cyropreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
- CSIDE: A Randomized Trial of Low Versus Moderate Exposure Busulfan for INfants with Severe Combined Immunodeficiency (SCID) Receiving TCRαβ+/CD19+ Depleted Transplantation: A Phase II Study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC)
- FAM BMT: Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
- Allo-T-DART: A Phase 1 Trial of Targeted Immunotherapy with Daratumumab following myeloablative Total Body Irradiation (TBI)-Based Conditioning and Allogeneic Hematopoietic Cell Transplantation in Children, Adolescents, and Young Adults with High-Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (T-ALL/T-LLy) (ALLO-T-DART)
- Foresight: Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commerically Available Immunotherapy
- NK T Cell - Pilot Study using Induction Chemo-Immunotherapy Followed by Consolidation with Reduced Toxicity Conditioning and Allogeneic Stem Cell Transplant in Advanced Stage Mature Non-Anaplastic T- or NK-cell Lymphoma/Leukemia in Children, Adolescents, and Young Adults
Neuroscience
SMA
- Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE (PIERRE) Trial
- An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered via the ThecaFlex DRx™ System (PIERRE-PK)
- A Phase IV Open-Label Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Patients with Spinal Muscular Atrophy after Gene Therapy
- A PHASE IV OPEN-LABEL STUDY EVALUATING THE EFFECTIVENESS AND SAFETY OF RISDIPLAM ADMINISTERED IN PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY WHO EXPERIENCED A PLATEAU OR DECLINE IN FUNCTION AFTER GENE THERAPY
DMD
- Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy
- CureDuchenne Link: A Resource to Support Research Studies in Duchenne and Becker Muscular Dystrophy (DMD/BMD)
- A Phase II Multicenter, Open-Label Study to Evaulate the Efficacy, Safety Pharmacokinetics and Pharmacodynamics of Satralizumab in Pediatric Patients with Duchenne Muscular Dystrophy (SHIELD DMD).
Epilepsy
Migraine
- Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of Rimegepant for the treatment of migraine (with or without aura) in children and adolescents ≥ 6 to <18 years of age
- Multicenter, Open-Label Study To Assess The Long-Term Safety And Tolerability Of Rimegepant For The Acute Treatment Of Migraine (With Or Without Aura) In Children And Adolescents ≥ 6 To < 18 Years Of Age
- Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine (19356A)
- REJOIN - Long-term, open label (dose-blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine
Oncology & hematology
Medical oncology – solid tumors
- NMTRC 012: A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma
- MEMMAT: A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children with Recurrent/progressive Medulloblastoma, Ependymoma, and ATRT
- Kymriah: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release
- BCC 015: Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
- NMTRC 014: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DMFO)
- y-mAbs 1001: Phase 1 Trial with GD2-SADA: 177-Lu-DOTA Drug Complex in Patients with Recurrent or Refractory metastatic solid tumors known to express GD2, including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma, and Malignant Melanoma
- Emerge 101: A Phase 1/2 Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants with Relapsed/Refractory Ewing Sarcoma
- JPEH: A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination with Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults with Newly Diagnosed High-Grade Glioma Following Radiotherapy
- LIGHTBEAM 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilvertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors
Non-malignant hematological disorders
Pulmonary & pulmonary diseases – cystic fibrosis
- CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes (CHEC)
- Standardizing Treatments for Pulmonary Exacerbations: A Platform for evaluating treatment decisions to improve outcomes (STOP360)
- A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators (REACH)
Urology
Nephrology
- Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
- Advancing Transplantation Outcomes in Children: To compare whether de novo use of belatacept and sirolimus versus tacrolimus and MMF (Mycophenolate Mofetil) maintenance therapy will prevent the development of DSA or maintain optimal graft function
Contact us
Learn more about how to get involved with clinical trials.