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NCT ID: NCT01076348 Completed - Heart Failure Clinical Trials

Model 4965 Post-Approval Study

Start date: September 1996
Phase:
Study type: Observational

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

NCT ID: NCT01075802 Completed - Breast Cancer Clinical Trials

Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms

TADE
Start date: March 2010
Phase: N/A
Study type: Interventional

Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in women at high risk for developing the disease Tamoxifen needs to be activated in the body to an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable capability to activate tamoxifen due to variable function of this enzyme. Studies showed clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function. More recently, there were studies that showed the correlation with genetic variant of CYP2D6 and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients receiving tamoxifen treatment, but they did not specify how to interpret the genotype results and what kind actions to take in patient with adverse genotype. The aim of the investigators study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will increase endoxifen level to the same range of most patients who have wild type (normal functional)CYP2D6.

NCT ID: NCT01075789 Terminated - Clinical trials for Intubation; Difficult

Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children

NGTIPPS
Start date: May 2010
Phase: N/A
Study type: Interventional

Nasogastric tube insertion is one of the most common invasive procedures performed in children's hospitals, and has long been recognised as one of the most traumatic and painful. As a once off procedure, a nasogastric tube insertion is extremely distressing but the repeated procedures that many children endure as a necessary part of treatment for a chronic disease can be so traumatic that psychological damage may occur. There have been a limited number of studies carried out which have looked at methods to reduce the pain and trauma associated with this procedure, but most of these have been carried out in the adult population. The investigators propose to carry out a research project in a paediatric setting to definitively investigate the use of local anaesthetic spray, in combination with local anaesthetic gel, to numb the nasal passages and the back of the throat, with the aim of reducing or removing the unpleasant sensation of the nasogastric tube placement. If the study shows a benefit from the use of local anaesthetics, it would be an inexpensive and easily incorporated intervention that could be inserted into the routine procedure for nasogastric tube insertion.

NCT ID: NCT01075386 Completed - Endometrial Cancer Clinical Trials

The Effects of the Endocrine System on Endometrial Cancer

Ghrelin
Start date: October 2009
Phase:
Study type: Observational

Endometrial cancer usually begins in the endometrium, which is the tissue lining of the uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260 deaths from the disease every year. Most affected women are aged between 50 and 70 years. The purpose of this study is to investigate the possible role of the endocrine system in the regulation of human endometrial cancer. By looking at the laboratory results of people with endometrial cancer and also those without endometrial cancer we hope to gain a better understanding of how endometrial cancer develops and progresses. This may lead to the development of new, effective therapies for endometrial cancer.

NCT ID: NCT01075282 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)

AWARD-2
Start date: February 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

NCT ID: NCT01074944 Completed - Gaucher Disease Clinical Trials

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)

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

The primary objective of this study is to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective is to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) is administered QD and BID in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

NCT ID: NCT01074697 Completed - Nausea Clinical Trials

Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

GAND-emesis
Start date: April 2010
Phase: Phase 3
Study type: Interventional

GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy. The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.

NCT ID: NCT01074047 Completed - Clinical trials for Acute Myeloid Leukemia

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Start date: June 1, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

NCT ID: NCT01073163 Completed - Clinical trials for Non-Hodgkin's Lymphoma

Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

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

The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).

NCT ID: NCT01072630 Completed - Depression Clinical Trials

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.