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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: NCT00413205 Completed - Emphysema Clinical Trials

TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)

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

This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.

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: NCT00412893 Completed - Aspergillosis Clinical Trials

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Start date: March 7, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

NCT ID: NCT00412776 Terminated - Clinical trials for Head and Neck Cancer

Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Start date: December 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

NCT ID: NCT00412737 Completed - Influenza Clinical Trials

A Study of Tamiflu (Oseltamivir) for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

Start date: n/a
Phase: Phase 4
Study type: Interventional

This 2 arm study will evaluate the efficacy and safety of Tamiflu in the seasonal prophylaxis of influenza in immunocompromised patients (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive Tamiflu syrup or capsules 30mg-75mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00411853 Recruiting - Clinical trials for Hormone Refractory Prostate Cancer

Efficacy of FWGE in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients

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

We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line hormone therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective. The study will be conducted during two years with 60 patients. The efficacy will be assessed in terms of clinical and serological response and by specific questionnaires. This concept is based on previous reports regarding other diseases such as colon cancer, where the addition of a new drug to a drug which previously had failed, improved the patients' survival, the quality of life and the clinical parameters. In addition, preclinical data have shown activity of that regimen in prostate cancer cell lines and in animals' models. FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It increased the natural immune responses while decreasing the systemic inflammation often present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice and prolonged their survival. It delayed disease progression, increased overall survivals, improve quality of life and reduce oxidative stress. The long-term goal of this research is that the addition of FWGE to a drug which previously had failed, would slow down disease progression in patients with advanced and thus refractory cancers, improving the patients' quality of life, their clinical parameters and survival.

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: NCT00411021 Recruiting - Infertility Clinical Trials

Endometrial Sampling (Pipelle)in IVF Patients

Start date: n/a
Phase: N/A
Study type: Interventional

A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.

NCT ID: NCT00410384 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

BLISS-76
Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.