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NCT ID: NCT02608606 Completed - Clinical trials for Evidence of Liver Transplantation

Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors

FKosl
Start date: March 2015
Phase: N/A
Study type: Interventional

After liver transplantation one of the most important cost, for both patients and their health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral administration is the usual route, however, sublingual (SL) administration has been recently reported. This method of administration avoids first pass metabolism and allows an alternative route after transplant surgery, particularly in those patients who should extend the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral administration, is significantly lower, even up to 50%, which can result in considerable savings in short and long term. Among these studies, only one was conducted in liver recipients. This study suggest that SL administration of tacrolimus could allow to obtain similar concentrations compared with oral administration. The design of this study did not assess the existence of differences in the dose required and only included six patients.

NCT ID: NCT02608086 Completed - PTSD Clinical Trials

Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room

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

Psychological First Aid (PFA) is currently the most recommended early intervention for people affected by recent traumatic events, especially in the aftermath of natural disasters. Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic Stress Disorder (PTSD) nor other post-traumatic disorders or symptoms of distress. This project aims to evaluate the efficacy and safety of Psychological First Aid for the prevention of PTSD and other post-traumatic disorders or symptoms.

NCT ID: NCT02605239 Completed - Tooth Discoloration Clinical Trials

Phycosocial Impact of Bleaching Teeth

PSYBLE
Start date: March 2013
Phase: N/A
Study type: Interventional

58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. Those patients were bleaching and included in this study and signed a consent form. The patients were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the OHIP-Esthetics , PIDAQ and OES questionnaire form, had 30 minutes to answer it, were completed before , immediately after and one month control post-bleaching procedure.

NCT ID: NCT02603354 Completed - Tooth Discoloration Clinical Trials

Efectiveness of a Brief Protocol by a Low (6%) Concentration Gel Peroxide Hydrogen of Teeth Bleaching

Brief6%
Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this clinical study was to evaluate, the effectiveness and sensitivity post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the efficacy with 2 different application protocols. This is a clinical randomized double-blind split-mouth study. 31 patients were treated with: one upper hemi arcade with one application of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6% hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the beginning, immediately after each session. Tooth colour variation and sensitivity were compared between both application protocols

NCT ID: NCT02600611 Completed - Clinical trials for Skin Structures and Soft Tissue Infections

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

REVIVE-1
Start date: November 1, 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

NCT ID: NCT02597933 Completed - Clinical trials for Scleroderma, Systemic

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Start date: November 12, 2015
Phase: Phase 3
Study type: Interventional

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

NCT ID: NCT02596230 Completed - Clinical trials for Venous Thromboembolism

RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Start date: November 5, 2015
Phase:
Study type: Observational

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.

NCT ID: NCT02595814 Terminated - Acute Heart Failure Clinical Trials

Global Non-interventional Heart Failure Disease Registry

REPORT-HF
Start date: July 23, 2014
Phase:
Study type: Observational [Patient Registry]

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

NCT ID: NCT02594371 Completed - Clinical trials for Metastatic Breast Cancer

Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer

Start date: December 2, 2015
Phase: Phase 3
Study type: Interventional

To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer

NCT ID: NCT02593266 Recruiting - Depression Clinical Trials

A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents

FamilyTalkCL
Start date: November 2013
Phase: N/A
Study type: Interventional

The overall aim of this pilot study is to evaluate the acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families. The PIP is a family intervention directed towards strengthening family functioning and enhancing resilience in children of depressed parents. It comprises several modules that work on psycho-education and skill development within the family nucleus. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).