Clinical trials: Parenteral Nutrition
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment…
- Trial name
- NCT02579265
- Testing
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Fresenius Kabi
Short Bowel Syndrome
rHGH and Intestinal Permeability in Intestinal Failure
Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)").
- Trial name
- rHGH (NCT01380366)
- Testing
- Somatropin, Seven Day Food Diary, Blood Tests (standard of care)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Northwestern University
Parenteral Nutrition Associated Cholestasis
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
- Trial name
- NCT01555957
- Testing
- intravenous lipid
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Rochester
Hyponatremia, Hypernatremia
Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid).
- Trial name
- NCT00734214
- Testing
- 0.9% NaCl, 0.45%NaCl
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Acromegaly
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical…
- Trial name
- MPOWERED (NCT02685709)
- Testing
- Octreotide capsules
- Where
- 53 sites in United States, Austria and 11 more
- Volunteers
- 146 people
- Sponsor
- Chiasma, Inc.
Short Bowel Syndrome
Short Bowel Syndrome and Teduglutide Versus Placebo
This research study was done to see what the effects are of Teduglutide on people with short bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection, which has shown to increase intestinal blood…
- Trial name
- NCT02099084
- Testing
- Teduglutide
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Mayo Clinic
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by…
- Trial name
- NCT00826020
- Testing
- Omegaven™
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Nebraska
Parenteral Nutrition
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications.
- Trial name
- TPN2 (NCT00672854)
- Testing
- ClinOleic 20% Intravenous Emulsion, Intralipid, 20% Intravenous Emulsion
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Emory University
Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia.
- Conditions
- Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Uterine Corpus Choriocarcinoma
- Trial name
- NCT00003702
- Testing
- Dactinomycin, Methotrexate
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Gynecologic Oncology Group
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Multiple Myeloma and Plasma Cell Neoplasm
Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00477971
- Testing
- filgrastim, dexamethasone, melphalan
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Mayo Clinic
Cholestasis of Parenteral Nutrition
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure.
- Trial name
- NCT03387579
- Testing
- Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Indiana University
Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
- Trial name
- NCT00081458
- Testing
- Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 84 people
- Sponsor
- Shire
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Short Bowel Syndrome
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive…
- Trial name
- NCT01952080
- Testing
- teduglutide
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 42 people
- Sponsor
- Shire
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
Acute Respiratory Failure With Hypoxia, Malnutrition
Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support…
- Trial name
- SuPPeR (NCT01937884)
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Arizona
Prostate Cancer
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer
The objective of the study is to determine if men with evidence of progressive prostate cancer while on chronic androgen ablation of ≥ 1 year duration will exhibit a clinical response following administration of parenteral…
- Trial name
- NCT01084759
- Testing
- Testosterone injection, Etoposide
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Advanced Cancer, Dehydration
Parenteral Hydration in Advanced Cancer Patients
The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.
- Trial name
- NCT00423722
- Testing
- Saline
- Where
- 5 sites in United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Post-Operative Pain
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.
- Trial name
- NCT01539538
- Testing
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Where
- 16 sites in United States
- Volunteers
- 357 people
- Sponsor
- Talphera, Inc