Phase 3 N=2 Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition-related Hepatitis
Primary: Disease Progression as Measured by Serum Levels of Hepatic Enzymes
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N/A N=136 Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
Parenteral Nutrition-Associated Liver Disease
Primary: The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. — 39; 45 participants who developed Cholestasis
Phase 2 N=11 Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Total Parenteral Nutrition-induced Cholestasis
Primary: Number of Participants With Normalization of Direct Bilirubin — 11 participants
Phase 2 N=72 Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Parenteral Nutrition Associated Liver Disease PNALD · Cholestasis
Primary: Number of Patients With Progression to Small Bowel Transplantation. — 19 Participants
Phase 3 N=21 Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Cholestasis
Primary: Rate of Rise of Direct Bilirubin as a Function of Time — 1.033001353; 1.05457485; 1.025504411; 1.049318179 mg/dL/day
Phase 3 N=100 Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Parenteral Nutrition
Primary: Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay — 21; 29 number of nosocomial infections
N/A N=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
Phase 4 N=48 Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition Associated Liver Disease
Primary: Number of Participants With Resolution of the Direct Hyperbilirubinemia — 29 Participants
N/A N=5,824 Comparison of Outcomes Between Parenteral and Enteral Nutrition
Deglutition Disorders
Primary: Mortality Calculated From Outcome Section From DPC Database at 90 Days — 359; 287 Participants
N/A N=484 Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)
Allogeneic Stem Cell Transplant · Graft Versus Host Disease · Hematologic Malignancy
Primary: Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade — 75; 73; 31; 63 Participants
Phase 3 N=2 Omegaven as Alternative Parenteral Fat Nutrition
Cholestasis · Cholestasis of Parenteral Nutrition
Primary: Number of Participant With Decrease in Direct Bilirubin Level — 2; 0 Participants
Phase 3 N=305 Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
Critically Ill
Primary: Documented Infection Rate — 58; 41 Infections
Phase 3 N=40 Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Parenteral Nutrition Associated Cholestasis
Primary: Number of Participants With Parenteral Nutrition Associated Cholestasis — 6; 6 Participants — p=0.94
N/A N=170 TPN-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
Hyperglycemia
Primary: Mortality — 36 mortality rate
N/A N=293 Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
Cholestasis · Cholestasis of Parenteral Nutrition
Primary: Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study — 38.02 Days
Phase 4 N=303 Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
Obstruction · Cancer · Ileus
Primary: Prealbumin — 0.15; 0.16 g/l
Phase 3 N=44 Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Cholestasis
Primary: Incidence of Neonatal Cholestasis — 1; 2 Participants
Phase 4 N=352 Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B Vaccine
Primary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 Participants
Phase 3 N=91 Cholestasis Reversal: Efficacy of IV Fish Oil
Parenteral Nutrition Associated Liver Disease · Short Bowel Syndrome · Gastrointestinal Disease
Primary: Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. — 11.7; 6.4 Weeks — p==0.001
Phase 3 N=12 Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Diseases, Metabolic · Insulin Sensitivity
Primary: Flow Mediated Dilation — 10.3; 8.9; 9.2; 9.1 percentage of brachial artery diameter
N/A N=19 Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy
Autoimmune Rheumatologic Disease
Primary: Hepatitis A Antibodies Titre — 9.4; 9.0; 394.7; 810.6 IU/L
Phase 3 N=277 Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Hepatitis B Virus Infection
Primary: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 — 49; 64 Participants
N/A N=2,410 Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
Acute Respiratory Failure · Shock
Primary: Mortality — 422; 443 Participants
N/A N=100 Clinical Experience With Numeta in Preterm Infants
Premature Infants
Primary: Protein — 3.1; 3.6 g/kg/d
Phase 2 N=48 Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Preterm Infants · Parenteral Nutrition n-3 Fatty Acids
Primary: Safety: Alanine Transaminase (ALT) — -0.83; -3.27 U/L — p=0.3654
Phase 2 N=55 Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis
Primary: Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. — -1.6; -0.1 NAS score units
N/A N=2,430 Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
Hepatitis C, Chronic · Hepatitis C
Primary: Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) — 685 participants
Phase 3 N=247 Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Liver Diseases
Primary: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and…
Phase 4 N=377 Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C
Chronic Hepatitis C
Primary: Sustained Virologic Response (SVR)Rate — 130; 72 participants — p=< 0.001
Phase 4 N=50 Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Pancreatic Cancer · Bile Duct Cancer
Primary: Postoperative Infectious Complication — 7; 15 participants — p=<0.05