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NCT ID: NCT01054248 Completed - Malaria Clinical Trials

Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy

DMA
Start date: February 16, 2010
Phase: Phase 3
Study type: Interventional

This is a randomised, open label trial, comparing standard dose of dihydroartemisinin-piperaquine (DP) with standard fixed artesunate-mefloquine regimen (MAS3) and with a longer regimen of artemether-lumefantrine (ALN+) in the treatment of uncomplicated malaria in pregnant women. The sample size is 335 women in each arm which would be 1005 women in total. Pregnant patients in 2nd and 3rd trimester with acute uncomplicated malaria who meet eligibility criteria will be asked to participate in the study. The primary objective is to determine if the efficacy of DP and MAS3 are superior to ALN+ in the treatment of uncomplicated malaria in pregnancy. The study will also incorporate a dense pharmacokinetic study of mefloquine and artesunate (15 women in the MAS3 arm) and a population pharmacokinetic study for mefloquine, piperaquine and lumefantrine.

NCT ID: NCT01051661 Completed - Influenza Clinical Trials

Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

Start date: February 12, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

NCT ID: NCT01051531 Completed - Schizophrenia Clinical Trials

A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia.

NCT ID: NCT01049763 Completed - Healthy Clinical Trials

Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects

Start date: January 2010
Phase: Phase 1
Study type: Interventional

This study is planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response to a new era influenza plan along with recognition of growing numbers of obese persons. The study findings will be available for a future management plan in dealing with this virus that is transmitted easily from person to person and has shown substantial antigenic changes over time. The primary focus of statistical analysis is to verify the effect of obesity on oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.

NCT ID: NCT01049711 Completed - Clinical trials for Chronic Renal Failure

Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients

CUAEPO
Start date: November 2009
Phase: N/A
Study type: Observational

To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.

NCT ID: NCT01048073 Completed - Clinical trials for Lower Respiratory Tract Infection

Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Start date: May 2010
Phase: N/A
Study type: Observational

Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses. The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia. This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings

NCT ID: NCT01044810 Completed - Clinical trials for Treatment Failure, HIV or AIDS

Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity

Start date: January 2010
Phase: N/A
Study type: Observational

The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).

NCT ID: NCT01044095 Completed - Influenza Clinical Trials

Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Start date: November 2009
Phase: N/A
Study type: Interventional

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

NCT ID: NCT01042769 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Start date: February 2010
Phase: Phase 3
Study type: Interventional

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

NCT ID: NCT01042457 Completed - Lupus Nephritis Clinical Trials

Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis

Start date: May 2009
Phase: Phase 3
Study type: Interventional

To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.