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NCT ID: NCT03189745 Not yet recruiting - Clinical trials for Meningococcal ACWY Disease

A Study To Evaluate A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Healthy Subjects Aged 11-17 Years Received Either Menacwy-tt Vaccine (Nimenrix(Registered)) Or Mencevax Acwy(Registered).

Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY

NCT ID: NCT03186209 Not yet recruiting - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)

Start date: September 15, 2017
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.

NCT ID: NCT03138941 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region

APLCLLDAS
Start date: September 1, 2013
Phase: N/A
Study type: Observational [Patient Registry]

Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.

NCT ID: NCT03123926 Recruiting - Preterm Delivery Clinical Trials

Spontaneous Preterm Birth Marker Test

Start date: November 2016
Phase: N/A
Study type: Observational

The prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. It defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. The understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. Five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. However, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. The early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. However, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.

NCT ID: NCT03114982 Completed - Varicella Clinical Trials

The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age

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

This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

NCT ID: NCT03114943 Active, not recruiting - Varicella Clinical Trials

Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

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

This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

NCT ID: NCT03113162 Recruiting - Multiple Sclerosis Clinical Trials

Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple Sclerosis

Start date: May 29, 2015
Phase: Phase 1
Study type: Interventional

This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.

NCT ID: NCT03050359 Recruiting - Duodenal Ulcer Clinical Trials

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

Start date: April 4, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.

NCT ID: NCT03050307 Recruiting - Clinical trials for Gastrointestinal Diseases

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection

Start date: April 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with gastric ulcer.

NCT ID: NCT03036150 Recruiting - Clinical trials for Chronic Kidney Disease

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Dapa-CKD
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease