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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: NCT00171340 Completed - Breast Cancer Clinical Trials

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

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

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

NCT ID: NCT00168337 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

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

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

NCT ID: NCT00168298 Completed - Macular Edema Clinical Trials

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Start date: November 1, 2004
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

NCT ID: NCT00159913 Completed - Clinical trials for Pulmonary Arterial Hypertension, Children

A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

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

This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.

NCT ID: NCT00159874 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

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

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

NCT ID: NCT00157339 Completed - Asthma Clinical Trials

Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

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

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

NCT ID: NCT00156078 Completed - Clinical trials for Diabetic Neuropathy, Painful

A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

Start date: January 2005
Phase: Phase 4
Study type: Interventional

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

NCT ID: NCT00151775 Completed - Hypertension Clinical Trials

Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

Start date: May 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.

NCT ID: NCT00141102 Completed - Osteoarthritis Clinical Trials

Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

CONDOR
Start date: October 2005
Phase: Phase 4
Study type: Interventional

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.