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NCT ID: NCT02619344 Completed - Clinical trials for Endothelial Dysfunction

Endothelial Dysfunction and Selenium Status in Children With Acute Systemic Inflammatory Response

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

The overall hypotheses of this project is that severe sepsis is associated with endothelial dysfunction in pediatric patients and that selenium deficiency is associated with changes in biological markers of endothelial dysfunction and that these changes, in turn, are associated with worse clinical prognosis.

NCT ID: NCT02618317 Completed - Clinical trials for Chronic Kidney Disease

Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis

CLOCK
Start date: July 2013
Phase: Phase 4
Study type: Interventional

Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H. Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA). Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.

NCT ID: NCT02617940 Completed - Fissure Sealants Clinical Trials

Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children

SLM1661
Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. The costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. Poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. This test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. Time, costs and impact on quality of life of the treatments will be compared by Student's t test. For all analyses, the significance level will be set at 5%.

NCT ID: NCT02617212 Completed - Alveolar Bone Loss Clinical Trials

Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.

Start date: November 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.

NCT ID: NCT02616068 Completed - Pain Clinical Trials

Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma

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

This study evaluates the non-inferiority of the new transdermal patch dosage form containing loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet - Daiichi-Sankyo) for the treatment of acute traumatic injuries.

NCT ID: NCT02615262 Completed - Cardiac Surgery Clinical Trials

Intraoperative Dexamethasone in Pediatric Cardiac Surgery

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

Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.

NCT ID: NCT02613832 Completed - Stroke Clinical Trials

Applicability of Techniques of Lung Expansion

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

The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

NCT ID: NCT02611830 Completed - Colitis, Ulcerative Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611817 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Start date: January 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02610842 Completed - Scleroderma Clinical Trials

Hands on - a Hand Care Guide in Systemic Sclerosis

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

Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.