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NCT ID: NCT00196794 Completed - Diarrhea Clinical Trials

A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.

NCT ID: NCT00196742 Recruiting - Fabry Disease Clinical Trials

Fabry Disease Registry & Pregnancy Sub-registry

Start date: July 31, 2001
Phase:
Study type: Observational [Patient Registry]

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00195715 Completed - Crohn's Disease Clinical Trials

Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Start date: September 2004
Phase: Phase 3
Study type: Interventional

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

NCT ID: NCT00195663 Completed - Clinical trials for Early Rheumatoid Arthritis

Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

PREMIER
Start date: December 2000
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

NCT ID: NCT00195559 Completed - Clinical trials for Premenstrual Syndrome

Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

NCT ID: NCT00195546 Completed - Menopause Clinical Trials

Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

NCT ID: NCT00195507 Completed - Psoriasis Clinical Trials

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

Start date: December 2004
Phase: Phase 4
Study type: Interventional

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

NCT ID: NCT00195312 Terminated - HIV Infections Clinical Trials

Study Evaluating Vaccine in Adults With HIV

Start date: August 2005
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV. A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.

NCT ID: NCT00195273 Completed - Clinical trials for Kidney Transplantation

Study Evaluating Sirolimus in Kidney Transplant Recipients

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

NCT ID: NCT00195195 Completed - Transplantation Clinical Trials

Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

Start date: January 2005
Phase: N/A
Study type: Observational

The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.