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NCT ID: NCT01135953 Completed - Healthy Volunteers Clinical Trials

Methods to Enhance Transcranial Direct Stimulation (tDCS)

Start date: January 2010
Phase: N/A
Study type: Interventional

tDCS has been shown to be an effective treatment for depression. However, tDCS is a relatively new clinical tool and more needs to be understood about its use. This study hopes to further the field of knowledge by examining how tDCS should be optimally used. Application of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this project, tDCS application will be to the motor cortex as it provides a more ready measure of excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated. Using a cross-over three-arm design this study aims to investigate whether daily tDCS administered in increasing intensity across sessions leads to greater and lasting effects on brain excitability than keeping the intensity at a same dose across the days and whether the excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the excitatory effects of a single session of tDCS. This in turn will inform on how to optimize tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that 5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS alone. The second hypothesis is that the gradational increases in tDCS intensity over 5 sessions will result in greater motor cortex excitability than 5 sessions of tDCS where intensity is kept constant across sessions.

NCT ID: NCT01135225 Completed - Clinical trials for Coronary Artery Disease

Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent

Evolve
Start date: July 2010
Phase: N/A
Study type: Interventional

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

NCT ID: NCT01135108 Completed - Spinal Cord Injury Clinical Trials

Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.

NCT ID: NCT01134562 Completed - Clinical trials for Hyperparathyroidism, Secondary

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Start date: September 7, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

NCT ID: NCT01134549 Completed - Clinical trials for Hyperparathyroidism, Secondary

Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers

Start date: June 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of KAI-4169 in healthy young males.

NCT ID: NCT01134263 Completed - Dengue Fever Clinical Trials

Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Start date: October 5, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses. Primary Objective - To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes. Secondary Objectives: - To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes. - To describe the safety of the CYD dengue vaccine in all participants after each dose.

NCT ID: NCT01134094 Completed - Ankle Fractures Clinical Trials

Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

CROSSBAT
Start date: August 2010
Phase: N/A
Study type: Interventional

This study will determine whether operative management confers improved short and long−term outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with non−operative management.

NCT ID: NCT01134055 Completed - Clinical trials for Macular Degeneration

Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration

Start date: June 1, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.

NCT ID: NCT01132508 Completed - Tibial Fractures Clinical Trials

Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Start date: September 2008
Phase: N/A
Study type: Observational

Case series of tibial plateau fractures using Norian Drillable.

NCT ID: NCT01132313 Completed - Clinical trials for Hepatitis C, Chronic

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

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

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)