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NCT ID: NCT01779570 Completed - Influenza Clinical Trials

Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections

Start date: February 2013
Phase: Phase 4
Study type: Interventional

Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.

NCT ID: NCT01774721 Completed - Clinical trials for Non-small Cell Lung Cancer With EGFR-Activating Mutations

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Start date: May 9, 2013
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

NCT ID: NCT01774019 Completed - Clinical trials for Pancreatic Carcinoma

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Start date: February 20, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

NCT ID: NCT01772901 Completed - Pregnancy Clinical Trials

Brief Influenza Vaccine Education to Pregnant Women

Start date: October 2013
Phase: N/A
Study type: Interventional

The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.

NCT ID: NCT01770106 Completed - Clinical trials for Rheumatoid Arthritis

RA Denosumab on Bone Microstructure Study

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare the effects of denosumab and a current standard treatment on cortical and trabecular microarchitecture at the radius and second metacarpal in rheumatoid arthritis (RA) patients with low bone mineral density using high resolution peripheral quantitative computed tomography (HR-pQCT) during a 6-month open-label randomized controlled study. Forty ambulatory Chinese females, who consent to receive alendronate as standard treatment subjective to the randomization, will be enrolled in this study. Subjects will be randomized to 2 arms receiving: 1) subcutaneous injection of denosumab 60mg (Prolia®) every 6 months (n=20), or 2) oral alendronate weekly (Fosamax® once weekly 70 mg, n=20). In addition, all patients will be given a daily calcium supplement (1500mg caltrate /day) and 1 multivitamin tablet per day. Efficacy and safety assessment will be performed at baseline, month 3 and month 6. aBMD of lumbar spine, total hip and non-dominant distal radius will be measured using dual-energy X-ray absorptiometry (DXA) and microarchitecture of bone is measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant hand using HR-pQCT.

NCT ID: NCT01767467 Completed - Herpes Zoster Clinical Trials

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Start date: March 1, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

NCT ID: NCT01766778 Completed - Clinical trials for Type-2 Diabetes Mellitus

Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

Start date: May 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study is to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.

NCT ID: NCT01765348 Completed - Clinical trials for Language Impairment in School-years

Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial

Start date: March 2012
Phase: N/A
Study type: Interventional

Specific-language-impairment (SLI) is defined as a significant disorder in language development, which affects one's daily functioning, but not attributable to sensory, intellectual or neuropsychological deficit. Children with SLI make up one of the largest subgroups of students with special educational needs (SEN) in Hong Kong. Without appropriate intervention, SLI may persist into adolescence and lead to long-term literacy difficulties and social rejection, which were found to be associated with societal problems like unemployment and crime commitment. Among the language domains, syntax/grammar has been viewed as a core deficit in these children. Speech-Language-Pathologists (SLPs) often provide intervention on this aspect for them. However, very few intervention efficacy studies could be identified. Without pertinent research evidence, clinical-decision-making in treatment approach selection may be dubious. This study aims to evaluate the efficacy of two procedures for syntax intervention, namely the Sentence-Combining (SC) and Narrative-Based (NAR) procedures using a randomized-controlled-trial (RCT) design. These two procedures have been indicated to be effective in previous case reports and expert opinions. By using the rigorous study design of RCT, this study provides stronger evidence to support clinicians in determining the most effective treatment procedure. To achieve sufficient statistical power to detect the treatment difference, 52 children with SLI will be recruited and randomly assigned to one of the treatment groups. The primary outcome will be measured by a standardized language assessment. Intention-to-treat analysis will be employed. Pre- and post-treatment scores on the outcomes will be subject to analyses of covariance with the pre-treatment scores as the covariate.

NCT ID: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01763918 Completed - Hyperlipidemia Clinical Trials

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

RUTHERFORD-2
Start date: February 7, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).