Clinical trials: Biliary Stasis
Alagille Syndrome, Cholestasis
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
- Conditions
- Alagille Syndrome, Cholestasis, Biliary Atresia
- Trial name
- NCT00007033
- Testing
- magnesium gluconate, magnesium sulfate
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Center for Research Resources (NCRR)
Cholestasis, Growth Failure
SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day.
- Trial name
- SMOF (NCT02412566)
- Testing
- SMOFlipid
- Where
- United States
- Sponsor
- Baylor College of Medicine
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy
Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
There is limited knowledge about the extent of the impact of maternal metabolic diseases (MD) and/or alterations in maternal serum lipid content upon neonatal lipid distribution and phenotypes.
- Conditions
- Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy, Metabolic Disease
- Trial name
- MRI-TIME (NCT04890886)
- Testing
- Thermal imaging, Echocardiogram, ECG
- Volunteers
- 80 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Alagille Syndrome
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US.
- Trial name
- NCT04530994
- Testing
- maralixibat
- Where
- 14 sites in United States
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated…
- Trial name
- NCT01412359
- Testing
- Omegaven®
- Where
- United States
- Sponsor
- Jeffrey Rudolph
Cholestasis, Liver Disease
Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants
To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.
- Trial name
- NCT02420496
- Testing
- Enteral fish oil, Ursodeoxycholic Acid
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
Parenteral Nutrition Associated Liver Disease
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil.
- Trial name
- NCT00862446
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Vanderbilt University Medical Center
Liver Cirrhosis, Biliary
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II.
- Trial name
- NCT00004748
- Testing
- colchicine, methotrexate, ursodiol
- Volunteers
- 90 people
- Sponsor
- National Center for Research Resources (NCRR)
Assessment of Physical Examination Skills for the Cardiovascular System, Determining Levels of Academic Self-Efficacy
Examining the Effects of ARCS-Based Education on Cardiovascular System Physical Examination Skills, Motivation, and Self-Efficacy Levels in Nursing Students
Objective: The purpose of this study is to determine the effect of ARCS-based nursing education on skill levels, motivation, and self-efficacy in the physical examination of the cardiovascular system.
- Conditions
- Assessment of Physical Examination Skills for the Cardiovascular System, Determining Levels of Academic Self-Efficacy, Determining Motivation Levels, Evaluation of the Effectiveness of the ARCS Intervention
- Trial name
- NCT07733479
- Testing
- ARCS Model Education, Structured Supplementary Training Based on the ARCS Motivation Model
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Cumhuriyet University
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Intrahepatic Cholestasis
Induction of Labor in Intrahepatic Cholestasis of Pregnancy
Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications.
- Trial name
- ILICP (NCT01381939)
- Volunteers
- 5,000 people
- Sponsor
- Karolinska Institutet
Chronic Pancreatitis, Inflammatory Bowel Diseases
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect…
- Conditions
- Chronic Pancreatitis, Inflammatory Bowel Diseases, Hepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- GREAT1 (NCT04306939)
- Testing
- venipuncture, Questionnaires, Additional Sample Collections
- Where
- United States
- Volunteers
- 120,000 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Cholestasis, Congenital Heart Disease
Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years
Congenital heart diseases (CHDs) are common in infants with cholestasis due to shared prenatal and metabolic factors. This study aims to determine the frequency and types of CHDs and to assess physical and mental development in…
- Trial name
- NCT07247604
- Volunteers
- 106 people
- Sponsor
- Assiut University
Extrahepatic Cholestasis
Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to…
- Trial name
- NCT03237247
- Volunteers
- 38 people
- Sponsor
- Assiut University
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Malnutrition, Child, Malnutrition
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
- Conditions
- Malnutrition, Child, Malnutrition, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis
- Trial name
- NCT06049680
- Testing
- SMOFlipid® (lipid injectable emulsion)
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Fresenius Kabi
Primary Biliary Cirrhosis
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to several symptoms such as intractable pruritus or chronic fatigue, significantly impairing patients quality of life.
- Trial name
- NCT02557360
- Testing
- S-adenosyl-L-methionine
- Where
- 2 sites in Poland
- Volunteers
- 24 people
- Sponsor
- Pomeranian Medical University Szczecin
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University