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NCT ID: NCT03439982 Completed - Clinical trials for Hepatic Encephalopathy

Fecal Transplant for Hepatic Encephalopathy

Start date: April 12, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

NCT ID: NCT03439670 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

Start date: June 29, 2018
Phase: Phase 2
Study type: Interventional

Brief Summary: This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.

NCT ID: NCT03439657 Completed - Herpes Zoster Clinical Trials

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

Start date: April 12, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

NCT ID: NCT03439631 Completed - Surgery Clinical Trials

Patient Satisfaction With Tiered OR Versus Status Quo OR

Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Operating room (OR) costs consume a significant portion of hospital budgets. Standard or "Status Quo" ORs are equipped with the same, fixed set of assigned resources, regardless of case complexity or actual resource requirements. Allocation of resources in standard ORs is the same whether the participant is having heart surgery or bunion removal. The investigators propose a strategy for OR design and set up wherein resources are carefully matched to procedure complexity as a novel means of healthcare delivery. This prospective, comparative cohort pilot study will compare two operating room (OR) setup designs. The Tiered OR setup (study intervention) will be an efficiently staffed and equipped OR, geared to the complexity of the surgical procedure. The level of care provided would be equivalent to that of an out-patient day surgery setup. The Status Quo OR setup (control intervention) will be a standard fully equipped, fully staffed OR.

NCT ID: NCT03439319 Completed - Clinical trials for Spinal Cord Injuries

Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.

NCT ID: NCT03439254 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

REVERSE
Start date: August 30, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

NCT ID: NCT03439072 Completed - Clinical trials for Type 1 Diabetes Mellitus

G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes

Start date: January 23, 2018
Phase: Phase 3
Study type: Interventional

This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50 mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedure are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

NCT ID: NCT03439059 Completed - Quality of Life Clinical Trials

REducing SEDENTary Behaviour May Slow Cognitive Decline in Older Adults With Mild Cognitive Impairment: A Pilot Study

RESEDENT
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

With the nation's fastest growing demographic being adults over 65, one in every three seniors is estimated to die from Alzheimer's Disease (AD). The strong correlation between AD and age, combined with the exponential growth of this demographic, highlights the need for non-pharmaceutical treatment/prevention strategies. Research has established a relationship between moderate to vigorous physical activity (PA) and improved cognitive functioning. However, there is insufficient evidence to support this relationship at the lower end of the PA spectrum. Assisted living facilities (ALF) are an easy target for reducing SB, as many individuals in these facilities have various functional limitations and therefore cannot meet the recommended PA guidelines. Older adults are also the most sedentary population, with results showing over 8.5+ hours daily spent in SB. ALF typically provide meals, laundry services as well as housekeeping duties, leaving the residents very susceptible to large amounts of SB. The primary purpose of my study is investigating how reducing sedentary behaviour (SB) in ALF will affect Alzheimer's Disease Assessment Scale-cognitive scores among older adults aged 65 and older with mild-to-moderate cognitive impairment. I will also investigate its effects on physical functioning with the Timed Up and Go test (TUG) and quality of life with the Short Form 36 (SF-36) Health Survey. Participants will be prompted to take a 10-minute light intensity PA break at three different time points throughout the day, reallocating SB to any task equating to over 1.5 metabolic equivalents. Positive findings may encourage ALF to implement policies and procedures regarding SB.

NCT ID: NCT03438097 Completed - Septic Shock Clinical Trials

Survey of Non-resuscitation Fluids in Septic Shock

SURF
Start date: March 1, 2018
Phase:
Study type: Observational

The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission.

NCT ID: NCT03437278 Completed - Clinical trials for Chronic Spontaneous Urticaria

Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses of H1 antihistamines (H1AH) following the guideline on treatment of CSU.