Treatment Trials

10 Clinical Trials for Various Conditions

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COMPLETED
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
Description

The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).

COMPLETED
Nutritional Therapy Interventions in Heart Failure
Description

The investigators will examine the effects of 12-weeks of nutritional interventions in older participants who have a symptom of mild to moderate heart failure.

COMPLETED
Nutritional and Functional Changes in Heart Failure and COPD
Description

Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this cross-sectional study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to decreased gut function and absorption, leading to decreased anabolic response. Second, this decreased nutritional status is linked to reduced muscle functioning and possibly decreased cognition. In addition, we will examine the effect of aging on by comparing gut function digestion and absorption of the CHF and COPD aged matched healthy controls to a group of young healthy subjects.

COMPLETED
Nutritional Therapy for Autonomic Dysfunction in Elderly Heart Failure Patients
Description

Recent studies suggest that patients with heart failure (HF) may have a reduced ability to control the tone of their blood vessels, heart rate or blood pressure in response to stress. This study will test whether 16 weeks of protein supplements can improve control of blood pressure and heart rate in HF patients.

Conditions
RECRUITING
Enhanced Nutritional Optimization in LVAD Trial
Description

The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.

COMPLETED
Nutritional Stimulation of Growth in Children With Short Stature
Description

Short stature is a frequent reason for referral to a pediatric endocrinology clinic. Short stature is especially prevalent among those with failure to thrive (whose weight is significantly below the average weight of his/her peers). The growth hormone has limited efficacy for medical treatment of short stature when the cause of short stature is not growth hormone deficiency. This study will investigate the effect of 6 months of nutritional supplement (essential amino acids) compared to placebo in the linear growth of short children who have not yet reached puberty.

COMPLETED
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Description

The purpose of this project is to conduct a preliminary test of the feasibility of a multi-micronutrient intervention to improve micronutrient status, cardiac function and quality of life in Veterans with Congestive Heart Failure (CHF).

COMPLETED
Baby Observational and Nutritional Study
Description

Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth. Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of infants. Two different doses of PERT will be evaluated for improving fat and nitrogen absorption in infants with CF.

COMPLETED
Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk
Description

This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).

WITHDRAWN
Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma
Description

Hepatocellular carcinoma (HCC) is the fifth most common cause of cancer death among men. While several new treatment options have recently become available, they are costly and have a potential for significant, adverse side effects. Many patients diagnosed with HCC also suffer from underlying liver disease, including cirrhosis. As many as 80-90% of patients diagnosed with HCC also have cirrhosis. Protein-energy malnutrition (PEM) in cirrhosis is as high as 65-90% and significantly increases the risk of morbidity and mortality as well as decreased quality of life. Branched-chain amino acid (BCAA) supplementation has been extensively studied for usefulness in liver disease, specifically to treat hepatic encephalopathy to and preserve and restore muscle mass. Maintenance of liver function and prevention of PEM are essential for improving outcomes in patients with HCC. Branched-chain amino acid supplementation in HCC has been studied extensively in China \& Japan with multiple studies showing improvements in liver function, progression-free survival, and overall survival. Additionally, patients in treatment groups have shown improvement in quality of life indicators. However, these results have yet to be replicated in the United States. Branched-chain amino acid supplementation may be a safe, low-cost approach to improve survival, liver function indicators, and quality of life for patients diagnosed with HCC. In this study, patients with primary HCC will be randomized to either a treatment group, which will receive standard of care and BCAA supplement or to a control group which will receive standard of care and a maltodextrin placebo. Both groups will receive liver-directed therapy including transarterial chemoembolization (TACE) and thermal ablation. All patients will complete a quality of life survey (FACT-Hep) at each visit.