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NCT ID: NCT01411241 Completed - Dengue Clinical Trials

Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

Start date: July 18, 2011
Phase: Phase 3
Study type: Interventional

The aim of the study was to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day visit but in 2 different sites of administration. Primary Objective: - To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo. Secondary Objectives: - To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo. - To describe the safety of the CYD dengue vaccine after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06). - To describe the safety of the CYD dengue vaccine in all participants after each dose. - To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine (at Visit 05) or administered alone (at Visit 06). - To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.

NCT ID: NCT01410604 Completed - Obesity Clinical Trials

Adipokines in Obese Adolescents With Insulin Resistance

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

The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).

NCT ID: NCT01408576 Completed - Clinical trials for Systemic Lupus Erythematosus

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

EMBODY4
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01408342 Withdrawn - Aplastic Anemia Clinical Trials

Alemtuzumab and Rituximab in Aplastic Anemia

Start date: July 2011
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.

NCT ID: NCT01405755 Completed - Clinical trials for Infant and Young Child Feeding

Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding

Start date: September 2010
Phase: N/A
Study type: Interventional

Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.

NCT ID: NCT01404585 Completed - Clinical trials for Rheumatoid Arthritis

Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

RA
Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is effective in treating moderate to severe rheumatoid arthritis.

NCT ID: NCT01402986 Completed - Asthma Clinical Trials

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma

NCT ID: NCT01400971 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes

MOSAIc
Start date: July 2011
Phase:
Study type: Observational

The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.

NCT ID: NCT01397786 Completed - Schizophrenia Clinical Trials

Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

ZENITH
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

NCT ID: NCT01396564 Completed - Type 2 Diabetes Clinical Trials

Pioglitazone and Metformin in Diabetic Children

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D). MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent, as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin. STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t test. Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The statistical significance between variables is determined using ANOVA. The effect of confounding variables is analyzed with a test of co-variance analysis. Statistical significance is considered as p <0.05.