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NCT ID: NCT01749852 Completed - Body Weight Clinical Trials

Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults

Start date: January 2013
Phase: N/A
Study type: Interventional

The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body weight/ body fat in the overweight and obese adult population.

NCT ID: NCT01749254 Completed - Clinical trials for Coronary Artery Disease

Novel Imaging Approaches To Identify Unstable Coronary Plaques

Start date: February 2012
Phase:
Study type: Observational

Cardiovascular disease is the leading cause of death in Scotland and the Western World. Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk stratification, to identify patients for intensive therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug interventions. Using positron emission tomography, we have recently shown that sodium 18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture. Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and unstable coronary artery disease. This has the potential to provide an innovative and highly valuable translational model with which to test novel therapeutic interventions targeted at reducing atheroma and plaque rupture. This could have major implications for the future treatment of cardiovascular disease.

NCT ID: NCT01749020 Completed - Insulin Resistance Clinical Trials

Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.

NCT ID: NCT01747915 Completed - Clinical trials for Generalized Tonic Clonic Seizures

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Start date: April 3, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

NCT ID: NCT01747863 Completed - Brain Injury Clinical Trials

Prospective Research in Infants With Mild Encephalopathy

PRIME
Start date: December 2012
Phase: N/A
Study type: Observational

A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.

NCT ID: NCT01747174 Completed - Clinical trials for ST-elevation Myocardial Infarction (STEMI)

REperfusion Facilitated by LOcal Adjunctive Therapy in ST-elevation Myocardial Infarction

REFLO-STEMI
Start date: October 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether intra-coronary adenosine or sodium nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters and infarct size as measured with cardiac MRI, compared with standard treatment following thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).

NCT ID: NCT01747122 Completed - Clinical trials for Open Liver Resection

The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

LIVER 2
Start date: December 2012
Phase: N/A
Study type: Interventional

The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.

NCT ID: NCT01746524 Completed - Osteoarthritis Clinical Trials

Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System

10004
Start date: November 1, 2012
Phase:
Study type: Observational

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).

NCT ID: NCT01745861 Completed - Clinical trials for Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis

Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

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

The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. In the majority of patients the condition is mild, but about 25% of patients suffer a severe attack and between 30 and 50% of these patients dies. The usual cause of death is multiple organ failure secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic inflammatory response syndrome (SIRS). Studies with omega-3 fish oil have shown to control inflammatory process and improve the outcome especially in hyperinflammatory conditions. This research will look at the effects of supplementing omega-3 fish oil to patients with severe acute pancreatitis (severe inflammation of the pancreas). Patients with severe acute pancreatitis will be prospectively and blindly randomised into either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical care will be provided to all patients as per the national management guidelines. Each patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for discharge by their own medical team or for a maximum of SEVEN days. The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish oil could improve the clinical outcome in patients with severe acute pancreatitis.

NCT ID: NCT01745289 Completed - Breast Cancer Clinical Trials

Long-term Anastrozole Versus Tamoxifen Treatment Effects

LATTE
Start date: October 2010
Phase:
Study type: Observational

Established in 2010, the Long-term Anastrozole vs Tamoxifen Treatment Effects (LATTE) observational study aims to collect vital long-term safety and efficacy data on anastrozole and tamoxifen, drugs that were taken by post-menopausal women as part of the Anastrozole Tamoxifen Alone or in Combination (ATAC) trial. ATAC was a crucial breast cancer trial evaluating the use of aromatase inhibitors (AIs) in the adjuvant setting, with a median follow-up of over 10 years. The ATAC trial assessed the safety and efficacy of anastrozole+placebo, tamoxifen+placebo and anastrozole+tamoxifen in postmenopausal women undergoing treatment for invasive primary breast cancer