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NCT ID: NCT00530166 Terminated - Asthma Clinical Trials

Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

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

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.

NCT ID: NCT00428051 Terminated - Sepsis Clinical Trials

Colombia Epidemiologic Surveillance Study

LEAP II
Start date: September 2006
Phase: N/A
Study type: Observational

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

NCT ID: NCT00342173 Terminated - Cervical Neoplasia Clinical Trials

Costa Rican Natural History Study of HPV and Cervical Neoplasia

Start date: May 20, 1999
Phase:
Study type: Observational

A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancer were treated by Social Security Administration clinicians using standard local protocols. Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who have been followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group will be seen once after enrollment, at their fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit will be added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women are being followed passively via linkage to the cytology and tumor registries in Cost Rica. Clinical visits conducted during follow-up consist of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. Pap smear is prepared during the pelvic examination, and additional cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also collected from each participant at the time of their follow-up visits. During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.

NCT ID: NCT00315549 Terminated - Tonsillitis Clinical Trials

TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

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

This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

NCT ID: NCT00315042 Terminated - Tonsillitis Clinical Trials

TELI TON - Telithromycin in Tonsillitis

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

This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

NCT ID: NCT00315003 Terminated - Clinical trials for Otitis Media, Suppurative

TELI COM - Telithromycin in Children With Otitis Media

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

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.

NCT ID: NCT00265382 Terminated - Schizophrenia Clinical Trials

Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

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

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

NCT ID: NCT00257192 Terminated - Schizophrenia Clinical Trials

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

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

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

NCT ID: NCT00239681 Terminated - Clinical trials for Elevated High-sensitivity C-Reactive Protein (hsCRP)

JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

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

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

NCT ID: NCT00138671 Terminated - Diabetes Mellitus Clinical Trials

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

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

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.