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NCT ID: NCT00191152 Completed - Breast Cancer Clinical Trials

A Phase III Trial For Patients With Metastatic Breast Cancer

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

NCT ID: NCT00190892 Completed - Bipolar Disorder Clinical Trials

Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

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

This trial will assess any efficacious benefit and any safety issues associated with the concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I disorder, manic or mixed episodes

NCT ID: NCT00190840 Completed - Clinical trials for Carcinoma, Non-Small Cell Lung

A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer

Start date: September 2003
Phase: Phase 2
Study type: Interventional

In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.

NCT ID: NCT00190684 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Long-Term, Open Label Atomoxetine Study

Start date: August 2000
Phase: Phase 3
Study type: Interventional

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term). Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

NCT ID: NCT00189839 Completed - Clinical trials for Kidney Transplantation

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

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

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

NCT ID: NCT00189826 Completed - Clinical trials for Liver Transplantation

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

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

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

NCT ID: NCT00189306 Completed - Clinical trials for Superficial Basal Cell Carcinoma

Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

Start date: March 2001
Phase: Phase 3
Study type: Interventional

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

NCT ID: NCT00188331 Completed - Fatigue Clinical Trials

Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy

Start date: November 2003
Phase: N/A
Study type: Observational

This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue (the FACT-F), and validated tests of cognitive function, will be applied at predetermined times before, during and after chemotherapy, to determine the incidence, severity and duration of these symptoms. Comparisons will be made in changes in cognition for individuals, as well as between the chemotherapy and the control group. Mechanisms that might lead to fatigue and/or cognitive decline will be investigated.

NCT ID: NCT00184678 Completed - Clinical trials for Adult Growth Hormone Deficiency

Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

NCT ID: NCT00184665 Completed - Diabetes Clinical Trials

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

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

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).