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A Study to Evaluate Practical Anemia Bundle for SusTained Blood Recovery
Rochester, MN
The purpose of this research is to test a treatment plan to help reduce further anemia (a low blood count or hemoglobin level) and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).
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Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.
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Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status
Scottsdale/Phoenix, AZ
Do ambulatory RBC transfusions improve home functional status?
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Study of DISC-0974 in Participants With Myelofibrosis and Anemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis and anemia.
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Allogeneic Stem Cell Transplantation for Patients with Severe Aplastic Anemia
Rochester, MN
For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :
- Patient survival probability at 100 days, 1 year and 2 years.
- Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic ...
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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Jacksonville, FL
The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
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Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Jacksonville, FL
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
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A Phase 2, Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Luspatercept (ACE-536) in Subjects with Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia with and without Red Blood Cell-Transfusion Dependence
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.
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A Safety Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)
Rochester, MN
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001.
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Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Jacksonville, FL
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia without a deletion 5q cytogenetic abnormality.
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A Study to Measure Hemolysis Markers in Subjects with Warm Autoimmune Hemolytic Anemia
Rochester, MN
The purpose of this study is to measure and characterize markers of hemolysis (including but not limited to lactate dehydrogenase, indirect bilirubin, haptoglobin, and reticulocyte count), complement activation, and direct antiglobulin test (DAT), from subjects with Warm Autoimmune Hemolytic Anemia (wAIHA).
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Myocardial Ischemia and Transfusion
Rochester, MN
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Jacksonville, FL
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
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Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With wAIHA or CAD
Rochester, MN
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA)
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
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The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Rochester, MN
Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).
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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
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A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Rochester, MN
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.
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A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the effectiveness and safety of Momelotinib (MMB) to Danazol (DAN) in treating and reducing disease related symptoms, the need for blood transfusions, and splenomegaly, in adults with primary Myelofibrosis (MF), post-polycythemia vera MF or post-essential thrombocythemia MF.
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to c The study ...
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Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Jacksonville, FL
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
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A Study to Evaluate Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
Rochester, MN
The primary purpose of this study is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.
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Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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Gene Editing Research With a Patient Centered Approach
Jacksonville, FL; Rochester, MN
The purpose of this project is to systematically engage clinicians/scientists, patients and their families as stakeholders critical to the future of gene editing governance, so as to ensure that their values and priorities are identified, understood and to the extent possible aligned.
The ultimate objective is to provide an integrated pathway to a governance structure for the future of prenatal human gene editing in the United States.
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"Prescribing" Exercise to Cancer Patients at High-Risk for Falls
Rochester, MN
Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.