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NCT ID: NCT00772330 Completed - Glaucoma Clinical Trials

Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Start date: October 2007
Phase: N/A
Study type: Interventional

Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.

NCT ID: NCT00702507 Completed - Diaper Rash Clinical Trials

Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

Start date: May 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

NCT ID: NCT00645203 Completed - Acute Otitis Media Clinical Trials

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Start date: July 2002
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

NCT ID: NCT00643292 Completed - Acute Otitis Media Clinical Trials

A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

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

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections

NCT ID: NCT00617851 Completed - Influenza Clinical Trials

Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

NCT ID: NCT00604084 Completed - Scabies Clinical Trials

Veron Scabies Education and Eradication Program

VSEEP
Start date: May 2007
Phase: N/A
Study type: Interventional

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical Lindane--a readily available medical formulation, pesticide, and environmental toxin that is reported to be banned in the Dominican Republic as well as over 80 other countries throughout the world.

NCT ID: NCT00591968 Completed - Clinical trials for Abdominal Aortic Aneurysm

Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community

Start date: January 2008
Phase: N/A
Study type: Interventional

The role of teleradiology has far reaching implications for the health of remote and underserved populations. The ability to coordinate radiographic evaluation and diagnosis from a distance has the potential to raise the standard of patient care throughout the world. Perhaps the safest and most cost effective mode of teleradiology today is telesonography. The current project attempts to determine the extent that telesonography improves the standard of care within a rural government-run primary clinic within the Dominican Republic. The work reported herein is intended to compare the use of telesonography to the current standard of sonographic examination (referral to government hospital 60km from target clinic). The study was conducted by randomly assigning 100 patients with clinical indications for sonographic examination into experimental and control groups. Following a 60-day implementation period, the following research questions will be addressed: 1) To what extent does the use of asynchronous telesonography increase the percentage of definitive diagnoses based on the total number of scans (definitive diagnoses / total number of scans)? 2) To what extent does the use of asynchronous telesonography increase the continuity of care for patients? 3) To what extent does the elapsed time between scanning and final radiological interpretation decrease with the use of asynchronous telesonography? This study will also look at the history of telemedicine / telesonography and its dissemination into the mainstream practice of medicine, explore training protocols that may be used to assist others to establish new telesonography programs in a developing nations, and discuss both advances and persistent barriers to the implementation of telesonography programs. Hypothesis: The use of a store-and-forward telesonography system in this setting will increase the speed and number of final diagnoses per scan received by the target clinic and will increase the continuity of care by increasing the number and speed of follow-up appointments to the target clinic.

NCT ID: NCT00570440 Completed - Clinical trials for Pregnancy Prevention

Continuous Use of COCs

Start date: August 2007
Phase: Phase 4
Study type: Interventional

The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.

NCT ID: NCT00561496 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel

Start date: March 2007
Phase: Phase 1
Study type: Interventional

This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervicovaginal samples and biopsies collected at one of seven time-points [0.5, 1, 2, 4, 6, 8, and 24 hour(s)] after the single-dose. Blood samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose. In the two-week phase, the study supplies will be distributed and the participants will be randomized to apply each dose either once or twice-daily for two weeks. At the one week follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough value and cervicovaginal samples will be collected four hours after the morning dose. At the two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose. Participants will be randomized to have cervicovaginal samples and biopsies collected at either 4, 8 or 24 hours after the final morning dose. Up to 10 participants who have completed the first two phases of the study, will be asked to participate in a third phase to have cervicovaginal samples, biopsies and blood samples collected 12 hours after a single-dose.

NCT ID: NCT00518115 Completed - Clinical trials for Diabetes Mellitus, Type 2

Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

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

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.