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NCT ID: NCT02719743 Completed - Influenza Clinical Trials

A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age

Start date: July 7, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.

NCT ID: NCT02715726 Completed - Clinical trials for Hypercholesterolemia

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

ODYSSEY EAST
Start date: July 27, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: - To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment. - To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp[a]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1). - To evaluate the safety and tolerability of alirocumab. - To evaluate the development of anti-alirocumab antibodies. - To evaluate the pharmacokinetics (PK) of alirocumab.

NCT ID: NCT02714595 Completed - Sepsis Clinical Trials

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

CREDIBLE - CR
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.

NCT ID: NCT02713620 Completed - Hepatitis B Clinical Trials

Hepatitis B Vaccination in HIV-infected Adults

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.

NCT ID: NCT02710604 Completed - Infectious Disease Clinical Trials

Phase 2, Multiple Ascending Dose Proof of Concept Study

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

NCT ID: NCT02704468 Completed - Vascular Stiffness Clinical Trials

FGF21 Can Help Predicting Arterial Stiffness Measured by Cardio-ankle Vascular Index in Renal Transplant Patients

CAVIFGF21
Start date: January 2016
Phase: N/A
Study type: Observational [Patient Registry]

Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event after renal transplantation. And remain a major cause of mortality. The major risk marker is arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall stiffness and can estimated the risk of atherosclerosis. Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to study the association between CAVI and FGF-21 and their relations to various parameters that can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other traditional basic factors.

NCT ID: NCT02701946 Completed - Clinical trials for Postoperative Blood Loss

Efficacy of Modified Robert Jones Bandages on Reducing Invisible Blood Loss After Total Knee Arthroplasty

Start date: March 2016
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic surgery. Nevertheless, significant postoperative blood loss and requirement of blood transfusion are still problematic. Total blood loss in TKA can be divided into visible and invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and wound drainage while invisible blood loss (IBL) means residual blood in the knee, extravasation into the tissues and loss due to haemolysis. In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus intraoperative blood loss can be negligible and postoperative drainage is only considered as VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA. Therefore, the true total blood loss was underestimated if not takes IBL into account. Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in orthopaedic practice. Various techniques of application have been proposed. From the previous study, MRJB could make and maintain the anterolateral muscle compartment pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage after TKA is still controversy in clinical practice.

NCT ID: NCT02699658 Completed - Healthy Volunteers Clinical Trials

Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios. The aims of the study were to: 1. reveal the population pharmacokinetics, and 2. assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment. The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.

NCT ID: NCT02697734 Completed - Cushing's Disease Clinical Trials

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

LINC-4
Start date: October 3, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

NCT ID: NCT02697474 Completed - Hepatitis B Clinical Trials

Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

Start date: February 2016
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine. Primary objectives: - To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2]) - To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination). Secondary objectives: - To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.