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NCT ID: NCT00489268 Completed - Barrett Esophagus Clinical Trials

Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years

AIM
Start date: November 2003
Phase: N/A
Study type: Interventional

This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1 or 3 months. A complete response (CR) was defined as all biopsy specimens negative for Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the 2.5-year follow-up,the results of which were published . There is ample evidence that RFA for Barrett's esophagus is effective and safe. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA.

NCT ID: NCT00485264 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

Start date: September 17, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.

NCT ID: NCT00484198 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study of Rivoglitazone in Type 2 Diabetes Mellitus

Start date: April 23, 2007
Phase: Phase 3
Study type: Interventional

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

NCT ID: NCT00482352 Completed - Clinical trials for Untreated Adult Acute Lymphoblastic Leukemia

Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Start date: December 2003
Phase:
Study type: Observational

This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

NCT ID: NCT00479453 Completed - Clinical trials for Major Depressive Disorder

Lilly's Emotional and Physical Symptoms of Depression

LEAPS
Start date: August 2004
Phase: Phase 4
Study type: Interventional

To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting

NCT ID: NCT00474916 Completed - Neuropathic Pain Clinical Trials

Neuropathic Pain in Patients With Cancer

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

The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.

NCT ID: NCT00470275 Completed - Sarcoma Clinical Trials

Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma

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

RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.

NCT ID: NCT00468858 Completed - Dengue Fever Clinical Trials

A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

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

The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.

NCT ID: NCT00467051 Completed - Clinical trials for Recurrent Ovarian Germ Cell Tumor

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

Start date: November 5, 2007
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

NCT ID: NCT00464633 Completed - Clinical trials for Leukemia, Lymphocytic, Chronic

Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

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

Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: - to assess overall safety, - to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated.