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NCT ID: NCT00718783 Completed - Retinoblastoma Clinical Trials

Molecular Analysis of Retinoblastoma

Start date: April 2007
Phase: N/A
Study type: Observational

Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000 children. Retinoblastoma is more prevalent in Central America, where most patients present with advanced intraocular and extraocular disease. Therefore, we have formed collaboration with Central American investigators to provide us with frozen retinoblastoma tumors from patients undergoing routine enucleation. The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

NCT ID: NCT00698828 Completed - Cachexia Clinical Trials

SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

Start date: May 15, 2008
Phase: Phase 2
Study type: Interventional

To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.

NCT ID: NCT00553605 Completed - Pain Clinical Trials

Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic

NAP
Start date: June 2007
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.

NCT ID: NCT00356915 Completed - Clinical trials for Onychomycosis, Toenail Onychomychosis, Toenail Fungus.

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

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

Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

NCT ID: NCT00316706 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

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

This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00207532 Completed - Clinical trials for Spina Bifida and Anencephaly

Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Start date: March 2005
Phase: N/A
Study type: Interventional

CDC staff at the National Center on Birth Defects and Developmental Disabilities have been working closely with a Honduras-based organization, Project Healthy Children (PNS) and the Ministry of Health, on a folic acid supplementation study among female maquila workers. Participants are divided into two groups. One group receives a 1.0 milligram pill daily while the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess serum blood folate levels measured at baseline, midpoint, and endpoint of the study. Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily in raising blood folate levels.

NCT ID: NCT00196924 Completed - Clinical trials for Infections, Papillomavirus

Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.

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

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

NCT ID: NCT00140673 Completed - Clinical trials for Infections, Rotavirus

A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

Start date: August 5, 2003
Phase: Phase 3
Study type: Interventional

The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

NCT ID: NCT00139347 Completed - Clinical trials for Infections, Rotavirus

Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

NCT ID: NCT00043927 Completed - Clinical trials for Small Cell Lung Cancer

Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

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

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.