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NCT ID: NCT01362725 Completed - Clinical trials for Systolic Heart Failure

Spinal Cord Stimulation For Heart Failure

SCS HEART
Start date: April 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this feasibility study are to determine the safety of spinal cord stimulation (SCS) as a therapy in patients with systolic heart failure and to gather observational information for potential efficacy markers

NCT ID: NCT01362426 Completed - Schizophrenia Clinical Trials

Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

Start date: March 2011
Phase: Phase 4
Study type: Observational

The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.

NCT ID: NCT01361971 Completed - Obesity Clinical Trials

Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

HOTAIR
Start date: April 2011
Phase: N/A
Study type: Interventional

Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. This study has the potential to yield new and important insights into the insulin resistance in obesity.

NCT ID: NCT01361555 Terminated - Depression Clinical Trials

Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

NCT ID: NCT01360840 Completed - Clinical trials for Prostate Cancer Metastatic

EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer

PERSEUS
Start date: April 2011
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT01360710 Recruiting - Hypertension Clinical Trials

The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension

Start date: January 2012
Phase: Phase 4
Study type: Interventional

Obesity is a major risk factor for the development of hypertension. Based on population studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension can be directly attributed to obesity. Obesity per se is commonly associated with activation of the sympathetic nervous system with a predominant increase in sympathetic outflow to the kidneys and the peripheral vasculature and there is now conclusive evidence that heightened sympathetic nerve activity is a major contributor to the elevation in blood pressure associated with obesity, particularly in young subjects. In line with these findings, dietary weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity and lower blood pressure levels. Several lines of evidence have well documented the significant role of SNS activation in obesity associated hypertension and target organ damage. Weight loss is the preferred treatment option for obesity and its consequences and reduces both SNS activation and blood pressure. In the real world however, weight loss maintenance is rarely achieved in obese patients highlighting the urgent need for alternative treatment strategies. Given the crucial involvement of SNS activation in various aspects of the obesity related increase in blood pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents at an early stage is an obvious choice. The investigators therefore plan to examine the effects of the centrally sympatholytic agent moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity, regression of early target organ damage (heart, kidney and endothelium), metabolic and inflammatory markers in young obese subjects with hypertension in a randomized, double-blind clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to achieve similar blood pressure reductions in both groups. The investigators hypothesize that moxonidine treatment will result in significant improvements in these outcome parameters and beneficial effects beyond simple blood pressure reduction. Findings from this study could pave the way for an early and pathophysiology- tailored treatment strategy of obesity related hypertension and its detrimental consequences.

NCT ID: NCT01358877 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

APHINITY
Start date: November 8, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

NCT ID: NCT01358578 Completed - Clinical trials for Chronic Plaque Psoriasis

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

FIXTURE
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

NCT ID: NCT01358500 Recruiting - Opioid Dependence Clinical Trials

An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

FEN001
Start date: February 2012
Phase: N/A
Study type: Interventional

This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect and safety profile in opioid-dependent patients. The investigators anticipate that a well tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be related to the patient's maintenance opioid dose.

NCT ID: NCT01358357 Completed - Bipolar I Disorder Clinical Trials

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

PERSIST
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.