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NCT ID: NCT01260831 Completed - Clinical trials for Critically Ill Children

Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH)

EPOCH
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning System (Bedside-PEWS) on early identification of children at risk for near and actual cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.

NCT ID: NCT01260350 Completed - Clinical trials for Chronic Hepatitis C Infection

Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

NCT ID: NCT01247428 Completed - Clinical trials for Coronary Artery Disease

First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

DESSOLVE-I
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.

NCT ID: NCT01246986 Completed - Clinical trials for Carcinoma, Hepatocellular

A Study of LY2157299 in Participants With Hepatocellular Carcinoma

Start date: March 30, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.

NCT ID: NCT01246882 Completed - Stroke Clinical Trials

Stroke Inpatient Rehabilitation Reinforcement of ACTivity

SIRRACT
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of daily feedback about physical activity (number of bouts of walking, duration of bouts, total walking distance, average and fastest walking speed) and walking average speed compared to feedback about walking speed only on walking-related outcomes during inpatient rehabilitation for stroke. For the first time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and return a summary to the participants at each site.

NCT ID: NCT01245062 Completed - Melanoma Clinical Trials

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

Start date: November 22, 2010
Phase: Phase 3
Study type: Interventional

This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

NCT ID: NCT01243424 Completed - Clinical trials for Diabetes Mellitus, Type 2

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

Start date: November 11, 2010
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

NCT ID: NCT01243411 Completed - Peyronie's Disease Clinical Trials

A Study of AA4500 in Men With Peyronie's Disease

Start date: November 2010
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to <15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.

NCT ID: NCT01236976 Completed - Spinal Cord Injury Clinical Trials

SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury

SCIPAFull-On
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks. The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury. Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments. Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.

NCT ID: NCT01234701 Completed - Neoplasms Clinical Trials

Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)

MRevaluation
Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.