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NCT ID: NCT02316717 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis

Start date: December 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.

NCT ID: NCT02316353 Completed - Clinical trials for Hereditary Angioedema Types I and II

A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Start date: December 31, 2014
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.

NCT ID: NCT02312960 Completed - Clinical trials for Neoplasm Metastasis / Bone and Bones

Radium-223 Dichloride Long-term Follow-up Program

Start date: December 18, 2014
Phase: Phase 4
Study type: Interventional

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

NCT ID: NCT02312258 Completed - Multiple Myeloma Clinical Trials

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

NCT ID: NCT02310672 Completed - Clinical trials for Pulmonary Arterial Hypertension

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

REPAIR
Start date: June 1, 2015
Phase: Phase 4
Study type: Interventional

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

NCT ID: NCT02310139 Completed - Colonoscopy Clinical Trials

Failed/Difficult Colonoscopy Outcomes

FoDCO
Start date: May 2015
Phase:
Study type: Observational

Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this removal is also known as polypectomy. Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a tertiary centre with extensive experience in difficult colonoscopy or have an alternative test such as CT scan. The investigators unit has accumulated significant experience related to previously failed colonoscopy and anecdotally appears to have a high success rate in completing the procedure. The purpose of this project is to describe the investigators technical approach to management of patients with previously failed colonoscopy. There is no additional intervention and the project is observational in nature. The investigators will collect data on patient characteristics, the reason for the failure and what technique was used to overcome the difficulty. The investigators will also note whether the final outcome of the technique had any impact on the overall management of the patient.

NCT ID: NCT02309411 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

EINSTEINJr
Start date: January 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

NCT ID: NCT02309320 Completed - Clinical trials for Respiratory Syncytial Virus Infection

A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

NCT ID: NCT02308020 Completed - Breast Cancer Clinical Trials

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

Start date: April 20, 2015
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.

NCT ID: NCT02306746 Completed - Critical Illness Clinical Trials

The Augmented Versus Routine Approach to Giving Energy Trial

TARGET
Start date: June 16, 2016
Phase: Phase 3
Study type: Interventional

Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.