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NCT ID: NCT02561806 Completed - Plaque Psoriasis Clinical Trials

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

IXORA-S
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

NCT ID: NCT02561663 Completed - Metabolic Syndrome Clinical Trials

NWT03 and Arterial Stiffness

Start date: August 2015
Phase: N/A
Study type: Interventional

Rationale: Subjects with the metabolic syndrome have an increased risk of developing cardiovascular disease and a twofold risk of developing hypertension. A functional food ingredient with the ability to improve arterial stiffness, microcirculation and/or the ability to reduce blood pressure could potentially contribute to the delay or prevention of a range of cardiovascular diseases and could provide additional complimentary alternatives to pharmacological and lifestyle based interventions in the maintenance of cardiovascular health. Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV, characteristics of microcirculation, systolic and diastolic blood pressure, lipid and lipoprotein metabolism, glucose metabolism and incretins. Study design: Investigators propose to carry out a randomized, double-blind, placebo controlled crossover study. Study population: Eligible subjects will be male or female, non-smokers between 18-75 years of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end of the study. Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once daily, on separate occasions, for a period of 4 weeks and with a washout period between the two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or extended by 8 weeks, depending on the availability of the subject. Total study duration will be 10 - 16 weeks, depending on the duration of the washout period. Main study parameters/endpoints: Measurements will be performed at the start and end of each 4-week intervention period. Effects of NWT-03 supplementation will be calculated as the absolute differences between values obtained at each period. The main study endpoint is the change in cr-PWV. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Before the study starts, subjects will be screened to determine eligibility during a screening visit. During this visit, body weight, height, waist circumference and blood pressure will be measured and a venous blood sample (10 mL) will be collected. During the study, subjects will receive NWT-03 and placebo powders in random order and are asked to consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a food frequency questionnaire and to provide a spot urine sample at visits 4 and 7. Furthermore, subjects will be asked to keep a study diary throughout the duration of the study. Total time investment for the subjects will be approximately 19 hours. Apart from bruises or hematoma, rarely induced by blood sampling, no risks are associated with participation in this study.

NCT ID: NCT02560402 Completed - Sepsis Clinical Trials

The Relation Between the Renal Resistive Index and Glomerular Hyper Filtration

Start date: August 2015
Phase: N/A
Study type: Observational

Aim of the present study is to determine whether 1. RRI can predict glomerular hyperfiltration; 2. glomerular hyperfiltration is associated with low renal resistive index; 3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the sublingual microcirculation; 4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with bioimpedance analysis.

NCT ID: NCT02560207 Completed - Critically Ill Clinical Trials

Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

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

This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

NCT ID: NCT02560142 Completed - Healthy Volunteer Clinical Trials

A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants

Start date: August 2015
Phase: N/A
Study type: Observational

This is a single center non-interventional study in healthy participants for behavioral assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5 participants and will study the implementation of the behavioral tests and identify potential issues. Part B will involve 30 participants and will study the test-retest reliability. Duration of participation for each participant will be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2 study visits of 2 days each separated by a period of 14 days).

NCT ID: NCT02559908 Completed - Chin Retrusion Clinical Trials

A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

Start date: February 26, 2015
Phase: N/A
Study type: Interventional

This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

NCT ID: NCT02559310 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

LEAP
Start date: September 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

NCT ID: NCT02558894 Completed - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

Start date: November 16, 2015
Phase: Phase 2
Study type: Interventional

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

NCT ID: NCT02558296 Completed - Clinical trials for Type 2 Diabetes Mellitus

Bexagliflozin Efficacy and Safety Trial

BEST
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

NCT ID: NCT02558231 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

TRITON
Start date: May 1, 2016
Phase: Phase 3
Study type: Interventional

The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.