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NCT ID: NCT00418457 Completed - Breast Neoplasms Clinical Trials

Regional Anesthesia and Breast Cancer Recurrence

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

In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.

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: NCT00414271 Completed - Clinical trials for Stage T3-4NxM0 Gastric Cancer

Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer

Start date: January 2006
Phase: Phase 2
Study type: Interventional

Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme inhibited by 5-fluorouracil (5-FU). TS level in the tumour cells has been reported as predictive to response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. We plan to study TS by immunohistochemistry (IHC) in the paraffin blocks of tumour tissue. A combined comparative genomic hybridization (CGH) and expression microarray analysis of gastric cancer specimens before and after neoadjuvant chemotherapy. CGH will be performed using standard technique routinely done in Dr Patrick Tan's laboratory at the National Cancer Centre, which determines the gain or loss of DNA copies of each chromosome. Total RNA will be extracted from at least one biopsy sample which contains at least 50% cancer cells by homogenization of the tumour tissue and tri-sol method. 5 ug of RNA were amplified and hybridized with the C-DNA microarrays of 18K targets. Primary Objective 1. Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer. Secondary Objective 1. Complete clinical and pathological response rates to pre-operative chemotherapy in locally advanced gastric cancer 2. Complete resection rate. 3. Time to recurrence, disease free and overall survival 4. Correlation of clinical outcome with (Runt-related transcription factor) RUNX-3 methylation status and Thymidylate synthetase in the tumor tissue. 5. Correlation of CGH and gene expression profile and their changes after chemotherapy with clinical outcome. Patients may be included in the study only if they meet all of the following criteria: Age at least 18 years. Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia (Siewert Classification Type III) Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it is a cardia lesion). Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination. Patients must not have received any prior chemotherapy or hormonal therapy for the treatment of gastric cancer. Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12 weeks. Adequate organ function including the following: - Bone marrow: White blood cells (WBC) at least 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) at least 1.5 x 109/L Platelets at least 100 x 109/L Haemoglobin at least 9g/dL - Hepatic: Bilirubin within upper limit of normal (ULN), Aspartate transaminase (ALT) or Alanine transaminase (AST) not more than 2.5x ULN Alkaline phosphatase not more than 2.5x ULN. - Renal: creatinine not more than 1.5x ULN Signed informed consent by patient or legal representative. Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. The study plans to recruit 30 patients in 12-18 months.

NCT ID: NCT00413712 Completed - Clinical trials for Supraventricular Tachycardia

Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT

Start date: January 1997
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia.

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.

NCT ID: NCT00412984 Completed - Atrial Fibrillation Clinical Trials

Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

ARISTOTLE
Start date: December 31, 2006
Phase: Phase 3
Study type: Interventional

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

NCT ID: NCT00411528 Completed - Clinical trials for Metastatic Hormone Refractory Prostate Cancer

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

Start date: September 2006
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

NCT ID: NCT00411385 Completed - Chronic Hepatitis C Clinical Trials

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

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

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

NCT ID: NCT00410306 Completed - Hypogonadism Clinical Trials

Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

IPASS Nebido
Start date: October 2006
Phase: N/A
Study type: Observational

This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.

NCT ID: NCT00410202 Completed - Clinical trials for Hepatitis B, Chronic

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

DEFINE
Start date: March 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine