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NCT ID: NCT02222545 Completed - Clinical trials for Thrombotic Microangiopathies

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

Start date: November 2, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).

NCT ID: NCT02219568 Completed - Clinical trials for Gastrointestinal Bleeding

Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding

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

The purpose of this study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.

NCT ID: NCT02217592 Completed - Sepsis Clinical Trials

Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand

Start date: May 20, 2012
Phase: N/A
Study type: Observational

This is an observational study to identify the aetiology and factors associated with outcome of community-acquired sepsis and severe sepsis in Northeast Thailand. Potential study participants will be adult patients who are presented at the hospital with community-acquired sepsis. Clinical specimens (including blood, urine, sputum and throat swabs) will be collected from each participant on admission for culture, PCR and serological tests, and other laboratory tests, including inflammatory markers and genotyping. Participants' treatment will be closely monitored during the duration of their hospital stay. Blood will be again collected at 72 hours after admission. Participants will be contacted at 28 days after admission to determine clinical outcome by phone interview with standardized script. There will be a total of 5,020 patients enrolled in this study over 3 years.

NCT ID: NCT02217267 Completed - Clinical trials for Peripheral Neuropathy

Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Start date: August 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion

NCT ID: NCT02216123 Completed - Malaria, Vivax Clinical Trials

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Start date: April 30, 2015
Phase: Phase 3
Study type: Interventional

This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD) deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1 or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is 180 days, including screening and randomization to treatment (Day 1), three in-hospital days (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11 and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180). The primary safety data collected in this study will help to understand the hemolysis risk to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will support the results for sister study TAF112582, the pivotal phase III efficacy and safety study of the TQ program.

NCT ID: NCT02213796 Completed - Clinical trials for Initial Phase of Severe Sepsis and Septic Shock

Population Pharmacokinetics and Monte Carlo Dosing Simulations of Meropenem During the Early Phase of Severe Sepsis and Septic Shock in Critically Ill Patients in Intensive Care Units

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

This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem during early phase of severe sepsis and septic shock in critically ill patients in an intensive care unit. Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE II score, SOFA score, BUN, Cr and blood culture will be collected. Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried out during the first and second dose after 1g meropenem administration. Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h. Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr., 2001). The pharmacokinetics of meropenem will be modelled from concentration-time profile using compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will be conducted and the results will be reported as % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response)

NCT ID: NCT02213783 Completed - Clinical trials for Patients With Febrile Neutropenia

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Start date: February 2011
Phase: Phase 4
Study type: Interventional

This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.

NCT ID: NCT02213263 Completed - Follicular Lymphoma Clinical Trials

A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

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

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

NCT ID: NCT02208843 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Start date: October 2, 2014
Phase: Phase 4
Study type: Interventional

The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.

NCT ID: NCT02202356 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study of ALS-008176 in Infants Hospitalized With RSV

Start date: July 23, 2014
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)