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Clinical Studies
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A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of NST-6179 in Adult Subjects with Intestinal Failure-Associated Liver Disease (IFALD)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The prupose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in adult subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN).
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Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study (POS)
Rochester, Minn.
The purpose of this study is to assess the effects of Peptamen Intense on body weight in tube-fed adults with obesity.
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Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes
Rochester, Minn.
The purpose of this research study is to gather information on one specific part of a feeding tube, known as the adjustable skin disk. The goal of this research study is to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support one or more of the following: 1) adequate healing after feeding tube placement; 2) a reduced rate of complications associated with feeding tubes, such as leakage, skin breakdown, etc.; 3) ease of use; and 4) durability (holds up to usual wear and tear associated with feeding tube use).
Closed for Enrollment
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A Multicenter, Double-blind, Randomized, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects with Short Bowel Syndrome and Intestinal Failure (SBS-IF) (SBS-IF)
Rochester, Minn.
The primary purpose of this study is to evaluate the effectiveness of Apraglutide (5 mg subcutaneously (SC), once weekly) in reducing the administered volume per week of PS from baseline, compared with placebo in adults with Short Bowel Syndrome and Intestinal Failure.
Short bowel syndrome is a malabsorptive condition characterized by extreme reduction in functional small intestinal length most commonly as a result of surgical resection due to mesenteric ischemia or Inflammatory Bowel Disease (IBD) although other etiologies are also present.
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A ProspecTive Prevalence Study in Adolescent and Adult Patients Dependent on Parenteral
Nutrition to Assess tHe Incidence of Intestinal FailuRe-AssocIated LiVer DiseasE (THRIVE-1)
Rochester, Minn.
The purpose of this study is to improve international patient's understanding of the primary diagnosis and recommended treatment program, by reducing social, cultural and religious barriers that may hinder in our nursing education
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An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. (STARS extend)
Rochester, Minn.
The purpose of this study is to assess long-term safety and tolerability of apraglutide in subjects with Short Bowel Syndrome (SBS-IF).
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Blenderized Tube Feedings for Patients on Home Enteral Nutrition (HEN): A Pilot Study
Rochester, Minn.
The purpose of this study is to find the effectiveness of blenderized tube feedings in adult people started on the Home Enteral Nutrition Program.
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Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.
Rochester, Minn.
This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.
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Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates
Rochester, Minn.
This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.
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Feasibility and Efficacy of Smartphone App for Liver Transplant Recipients
Rochester, Minn.
The purpose of this study is to determine the effectiveness of the use of smartphone app based education, assessment and intervention modules to improve healthy behavior following liver transplant surgery.
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Patients and Family Caregivers Experiences of Home Enteral Nutrition
Rochester, Minn.
The purpose of this study is to explore the experiences of patients and their family caregivers who use tube feeding in the home setting as part of Mayo Clinic's Home Enteral Nutrition program.
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Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula (PATTY)
Rochester, Minn.
The purpose of this study is to evaluate patients who are intolerant of current enteral formula to be transitioned to peptide-based therapy to assess if tolerance is improved and if they are able to better meet nutritional needs.
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Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients
Rochester, Minn.
The primary aim of the study will be to assess impact on direct bilirubin with the use of Intralipid versus Smoflipid.
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Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid
Rochester, Minn.
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
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The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome: A Pilot Study
Rochester, Minn.
The purpose of this study is to examine the differences in percent of goal calories provided through blenderized tube feeding (BTF) and standard enteral formula, as well as to examine the impact in the gut microbiome in patients receiving BTF compared to standard formula.
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Usability of Educational Instructions for Mobility+ Pouch (Mobility+)
Rochester, Minn.
The purpose of this study is to determine the sufficiency of the instructions for use, demonstration video, and labeling relating to the Mobility+ system from users, caregivers, and healthcare professionals. This evaluation will enable Rockfield Medical Devices to assess the usability of Mobility+, ensure user and patient safety are prioritized and adequate information on use, precautions, warnings, and contraindications are provided as appropriate.
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