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NCT ID: NCT00418236 Completed - Breast Cancer Clinical Trials

Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density

Start date: October 2006
Phase: Phase 4
Study type: Observational

It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense. At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects. This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.

NCT ID: NCT00417209 Completed - Clinical trials for Pancreatic Neoplasms

Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

PAPRIKA
Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

NCT ID: NCT00417079 Completed - Neoplasms Clinical Trials

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

TROPIC
Start date: January 2007
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

NCT ID: NCT00415194 Completed - Clinical trials for Head and Neck Neoplasms

A Study for Patients With Head and Neck Cancer

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

NCT ID: NCT00414882 Completed - Clinical trials for Mycobacterium Tuberculosis

A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case Finding

Start date: July 10, 2007
Phase:
Study type: Observational

The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB) works better than another in reducing new cases of TB. The first plan is the DOTS program, which provides free TB treatment to people seeking it. The second plan provides free TB treatment to people seeking it and involves program staff going door-to-door in communities to identify new cases of TB, DOTS plus active case-finding program (ACF). Researchers believe that by detecting TB cases earlier and supervising treatment it will help to prevent spreading and decrease TB in these areas. The study population will be 200,000 people in 6 communities of Santa Cruz and 14 communities of Northeast Rio de Janeiro, Brazil, receiving DOTS or DOTS plus ACF. Individuals in the DOTS plus ACF part of the study will be interviewed 2-4 times during a 9 month period. Patients with symptoms will provide a sputum specimen. Patients identified as having TB will begin treatment and be observed for 6.

NCT ID: NCT00414661 Completed - Clinical trials for Arthritis, Rheumatoid

Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

Start date: April 2007
Phase: N/A
Study type: Observational

The purpose of this study is to follow the health of subjects who have previously been enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are only eligible for this study after they have completed all participation in other studies of CP-690,550.

NCT ID: NCT00414206 Terminated - Clinical trials for Macular Degeneration

Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)

Start date: March 2007
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-masked study comparing the safety and efficacy of ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular ("wet") age-related macular degeneration (NV-AMD).

NCT ID: NCT00413699 Completed - Clinical trials for Arthritis, Rheumatoid

Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

Start date: February 5, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

NCT ID: NCT00413660 Completed - Clinical trials for Arthritis, Rheumatoid

Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

NCT ID: NCT00413218 Completed - Mycoses Clinical Trials

Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Start date: March 8, 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.