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NCT ID: NCT01233258 Completed - Hemophilia A Clinical Trials

A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

Leopold II
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

NCT ID: NCT01232205 Completed - Preeclampsia Clinical Trials

Antioxidant Supplementation in Pregnant Women

ASIP1
Start date: June 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.

NCT ID: NCT01224756 Completed - Pain Clinical Trials

Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

Start date: November 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three times daily (TID), in the treatment of pain and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.

NCT ID: NCT01218906 Completed - Fever Clinical Trials

Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia

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

The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent dengue infection. The primary objectives are: - To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection. - To develop operational infrastructure for potential Phase III dengue efficacy trial sites. - To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.

NCT ID: NCT01204580 Completed - Clinical trials for Diabetes Mellitus, Type 2

ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination

DIAGRAM
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M Secondary Objectives: 1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy 2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M 3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)) 4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M 5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M 6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M 7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

NCT ID: NCT01158755 Completed - Pharmacokinetics Clinical Trials

Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years. There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.

NCT ID: NCT01131676 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

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

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

NCT ID: NCT01122563 Completed - Overactive Bladder Clinical Trials

A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

RESORT-2
Start date: September 2009
Phase: N/A
Study type: Observational

This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

NCT ID: NCT01122550 Completed - Overactive Bladder Clinical Trials

Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

RESORT-1
Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

NCT ID: NCT01076764 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

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

Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide