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NCT ID: NCT02167269 Completed - Anesthesia Clinical Trials

Comparison of Minimal Fresh Gas Requirements of Baby EAR and Jackson Rees Anesthetic Circuit

Start date: May 2014
Phase: N/A
Study type: Interventional

The investigators invented the baby enclosed afferent reservoir anesthesia circuit (Baby EAR) which could be used safely in children between 5 and 20 kg, using a fresh gas flow of 2.5 and 3 L/min in the spontaneous breathing and controlled breathing, respectively. There has as yet been no study comparing the minimal fresh gas flow between the Baby EAR and Jackson-Rees anesthesia circuit (JR).

NCT ID: NCT02166008 Completed - Clinical trials for Gastric Ulcer Induced by Anti-platelet Agent

Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

- Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents - Study Design: Single center, double-blind, randomized-control trial study - Study drug: Repamipide vs. placebo - Assessment criteria The patients will be discharged from the study when one of the followings occurred, 1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up 2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy 3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy 4. Evidence of recurrent myocardial infarction from stent thrombosis

NCT ID: NCT02164864 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Start date: July 22, 2014
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

NCT ID: NCT02164513 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 30, 2014
Phase: Phase 3
Study type: Interventional

The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD

NCT ID: NCT02162173 Completed - Clinical trials for Complication of Diagnostic Procedure

Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma

PIVI
Start date: December 2012
Phase: N/A
Study type: Interventional

Background: Familial adenomatous polyposis (FAP) patients are at risk to develop periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of the lesion is generally required to identify the presence of adenoma. However, the risk of tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous, therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV≥ 90% is required. Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and probe-based confocal endomicroscopy (pCLE) in FAP patients. Design: Diagnostic study. Setting: Single tertiary-care referral center. Patients: Twenty-six patients with previously diagnosed with FAP. Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by two different endoscopists for each of the technique. Histology from the matched lesion was used as the gold standard. Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and accuracy. With the threshold for negative predictive value (NPV) ≥ 90%

NCT ID: NCT02161289 Completed - HIV Testing, MSM Clinical Trials

Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men

HIV-NAT 120
Start date: September 2010
Phase: N/A
Study type: Observational

Objectives 1. To evaluate the acceptability and feasibility of "standard HIV prevention package" among Thai men who have sex with men (MSM) 2. To conduct a pilot study to demonstrate the acceptability and feasibility of internet-based social networking, asymptomatic sexually transmitted infection diagnosis and treatment and pre-exposure prophylaxis strategies as "potential HIV prevention methods" among Thai MSM 3. To use mathematical modeling to identify the most effective HIV prevention package optimized for Thai MSM Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC), age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.

NCT ID: NCT02158936 Terminated - Thrombocytopaenia Clinical Trials

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Start date: June 10, 2014
Phase: Phase 3
Study type: Interventional

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

NCT ID: NCT02157259 Completed - Sepsis Clinical Trials

An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia

SEA050
Start date: December 2013
Phase: N/A
Study type: Observational

This is an observational study to identify the etiology, management, and outcome of community-acquired sepsis and severe sepsis in children and adults in Southeast Asia. The study will take place in Thailand, Vietnam, and Indonesia, the partner countries of SEAICRN. Potential study patients will be any patients (both children and adults) who are presented at the hospital with community-acquired sepsis or severe sepsis and require hospitalization.

NCT ID: NCT02156453 Completed - Knee Osteoarthritis Clinical Trials

Functional Recovery After Total Knee Arthroplasty

Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Total knee replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western Ontario and Mcmaster Universities osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to evaluate functional outcome of the patients is to use the performance-based tests such as the two-minute walk test, but there is still little information regarding its use for evaluating functional recovery in patients receiving total knee arthroplasty. The objectives this study are: 1) to assess the relationship between self-report questionnaires and performance-based tests among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and postoperative functional performance of the patients.

NCT ID: NCT02155660 Completed - Clinical trials for Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

TERRANOVA
Start date: June 25, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.