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NCT ID: NCT00297895 Completed - Melanoma Clinical Trials

Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

Start date: September 30, 2004
Phase: N/A
Study type: Interventional

Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If the subject is sentinel node positive and meets study requirements, the subject is randomized to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound. Subjects are then followed for 10 years.

NCT ID: NCT00297687 Completed - Clinical trials for Meningitis, Meningococcal

Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

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

To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease

NCT ID: NCT00297414 Completed - Clinical trials for Mild Cognitive Impairment

An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

Start date: June 2004
Phase: Phase 3
Study type: Observational

The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

NCT ID: NCT00297271 Completed - Dementia Clinical Trials

Prospective Research in Memory Clinics (PRIME)

Start date: August 2005
Phase: Phase 4
Study type: Observational

The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.

NCT ID: NCT00297232 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Natalizumab (Tysabri) Re-Initiation of Dosing

STRATA
Start date: March 2006
Phase: Phase 3
Study type: Interventional

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

NCT ID: NCT00297102 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

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

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

NCT ID: NCT00296829 Completed - Influenza Clinical Trials

Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly

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

All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). Primary Objective: To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine. Secondary Objectives: - To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain. - To describe the safety profile after the vaccination in each study group - To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency. Observational Objectives: - To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site. - To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group. - To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity. - To evaluate the cellular mediated immune response in a subset of subjects.

NCT ID: NCT00296361 Completed - Clinical trials for Kidney Transplantation

To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

RESTORE
Start date: October 2004
Phase: Phase 3
Study type: Interventional

Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

NCT ID: NCT00296010 Terminated - Breast Cancer Clinical Trials

Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

CASA
Start date: August 2005
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer. PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.

NCT ID: NCT00295815 Completed - Glioblastoma Clinical Trials

Enzastaurin Versus Lomustine in Glioblastoma

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

This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).