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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: NCT02560948 Completed - Hay Fever Clinical Trials

Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

Start date: December 2015
Phase: Phase 3
Study type: Interventional

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.

NCT ID: NCT02558829 Completed - Clinical trials for Growth Hormone Deficiency With Pituitary Anomalies

Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

Start date: December 3, 2015
Phase: Phase 3
Study type: Interventional

The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.

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.

NCT ID: NCT02558192 Completed - Clinical trials for Nosocomial Infection

Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

Start date: January 2014
Phase: Phase 3
Study type: Interventional

Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.

NCT ID: NCT02556450 Completed - Heart Failure Clinical Trials

Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure

Homage
Start date: January 2016
Phase: Phase 2
Study type: Interventional

Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. Prevention is most efficient when directed toward patients at risk and when mechanistically targeted to patients most likely to respond. An increase in myocardial and possibly vascular collagen content (fibrosis) may be a major determinant of the transition to HF. In patients with hypertension and diabetes, two important risk-factors for HF, changes in blood markers of fibrosis occur before clinically overt HF develops. These markers are also related to prognosis. In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated with cardiovascular (CV) risk factors, and predicts development of HF. In animal models, Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction. The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3. Main objective is to investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and whether this effect is greater in patients with increased plasma concentrations of Gal-3.

NCT ID: NCT02555787 Completed - Clinical trials for Kidney Transplantation

Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

CHORUS
Start date: March 5, 2015
Phase:
Study type: Observational

A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

NCT ID: NCT02554708 Completed - Clinical trials for Intracranial Aneurysm

pCONus Treatment of Wide Neck Intracranial Aneurysms

pToWin
Start date: August 2015
Phase:
Study type: Observational

To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.

NCT ID: NCT02554266 Completed - Clinical trials for Peripheral Artery Disease

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

BTKRegistry
Start date: September 29, 2015
Phase:
Study type: Observational [Patient Registry]

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

NCT ID: NCT02554006 Completed - Quality of Life Clinical Trials

Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings

BATMAN
Start date: September 2015
Phase: N/A
Study type: Interventional

A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.