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NCT ID: NCT00866515 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole

Start date: December 22, 2008
Phase: Phase 1
Study type: Interventional

This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects. There will be two treatment periods each consisting of 7 days. During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.

NCT ID: NCT00866307 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Start date: February 23, 2009
Phase: Phase 1
Study type: Interventional

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

NCT ID: NCT00864851 Completed - Fabry Disease Clinical Trials

Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

Start date: December 29, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.

NCT ID: NCT00864799 Completed - Pregnancy Clinical Trials

Techniques to Improve Efficacy of Second Trimester Medical Termination

Start date: April 2009
Phase: N/A
Study type: Interventional

Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the synthetic prostaglandin E1 analogue misoprostol. This prostaglandin, although not licensed for use in pregnancy termination, is now a common abortifacient with a large accumulated experience both within Australia and internationally. Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. Misoprostol may be administered vaginally, orally, sublingually or buccally in the process of pregnancy termination. Each route of administration has its own advantages and disadvantages. The most appropriate route of administration, with the shortest duration of abortion and lowest side-effect profile has not been determined for all circumstances. The combination of mifepristone and misoprostol is an established and effective method for second trimester pregnancy termination. Prior studies have demonstrated a significant reduction in the duration of abortion with misoprostol when mifepristone priming is used. In November 2007, the TGA (Therapeutic Goods Administration) approved an application by the Principal Investigator of this planned study for Authorised Prescriber status for use of the antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and misoprostol has been used at KEMH for first and second trimester pregnancy termination of pregnancy, predominantly for circumstances of severe fetal abnormality. There is however limited data on the impact of gestation on the duration of second trimester termination. Almost all published studies to date have recruited women in the early second trimester (typically with a median of 16 weeks gestation). However, most terminations of pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates a significant impact of increasing gestation with prolongation of the duration of pregnancy termination. In this study the investigators aim to evaluate three misoprostol regimens for second trimester pregnancy termination following mifepristone priming with the primary intention to develop a protocol which results in a delivery rate within 24 hours for 95% of women at gestations <24 weeks. Secondary aims of this study will be to assess the incidence of maternal side-effects for each of the three regimens, the placental retention rates and the need for curettage for retained placental tissue. As the investigators will be using 3 different methods of misoprostol administration, the investigators will also review women's satisfaction with the three regimens for pregnancy termination.

NCT ID: NCT00864422 Completed - Clinical trials for Chronic Low Back Pain

Changes in Motor Cortex Following Exercises for Chronic Low Back Pain

Start date: October 2006
Phase: Phase 1
Study type: Interventional

The motor cortex of the brain changes following chronic pain and injury, and this is linked to pain-associated changes in motor behaviour. This study aimed to investigate whether therapeutic exercises in patients with chronic pain can induce reorganisation of the motor cortex and restore normal motor behaviour. The investigators hypothesised that motor training can induce reorganisation of the motor cortex and that these changes are related to improved motor behaviour.

NCT ID: NCT00864253 Completed - Malignant Melanoma Clinical Trials

A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

Start date: April 23, 2009
Phase: Phase 3
Study type: Interventional

The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

NCT ID: NCT00863681 Completed - Clinical trials for Hypertension, Pulmonary

BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

PATENT-2
Start date: March 12, 2009
Phase: Phase 3
Study type: Interventional

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

NCT ID: NCT00863655 Completed - Breast Cancer Clinical Trials

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

BOLERO-2
Start date: June 2009
Phase: Phase 3
Study type: Interventional

There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

NCT ID: NCT00863512 Completed - Lung Cancer Clinical Trials

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Start date: March 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

NCT ID: NCT00861614 Completed - Prostate Cancer Clinical Trials

Study of Immunotherapy to Treat Advanced Prostate Cancer

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone