Clinical Trials Logo

Filter by:
NCT ID: NCT02042742 Completed - Healthy Clinical Trials

Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

PROBELTEII
Start date: April 2013
Phase: Phase 4
Study type: Interventional

A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.

NCT ID: NCT02042144 Completed - Neoplasms Clinical Trials

Safety and Effectiveness of Regorafenib

Correlate
Start date: April 8, 2014
Phase: N/A
Study type: Observational

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.

NCT ID: NCT02041533 Completed - Clinical trials for Stage IV or Recurrent Non-Small Cell Lung Cancer

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

NCT ID: NCT02041208 Completed - Renal Anemia Clinical Trials

Variability of Hemoglobin Levels After Kidney Transplantation

Start date: March 2012
Phase: N/A
Study type: Observational

The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.

NCT ID: NCT02040584 Completed - Liver Transplant Clinical Trials

A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.

REDUCE
Start date: December 20, 2013
Phase: Phase 3
Study type: Interventional

Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF.

NCT ID: NCT02040441 Completed - Clinical trials for Diabetic Retinopathy

Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria

PRIORITY
Start date: March 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double blind, placebo-controlled and a prospective observational study. This study will be conducted at 15 study centers in various European countries. 1777 participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening period). Depending on the risk score of the urinary protein pattern, participants have been stratified into an observational group or an interventional group. Participants with the low risk pattern (observational group) attend visits annually after screening and baseline. Participants with the high risk pattern (interventional group) attend study visits every 13 weeks after screening and baseline. The interventional group has been allocated into one treatment group either receiving spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The allocation to one of the two treatment groups has been done by a random distribution procedure established before the study start. The results of the urine sample from the Screening visit has been analysed and the urine proteomic pattern is determined to be either low- or high risk pattern and will determine the further study program. Participants with a low-risk pattern (observational group): During the study period, participants attend an annual project visit, were regular diabetes care is performed and three urine samples are analysed for albuminuria. Participants with a high-risk pattern (intervention group): Participants with a high-risk pattern have been randomized to either spironolactone treatment or placebo. The treatment is one tablet for oral use to be taken once a day for the entire study period. Four times each year (every 13th week) a study visit is conducted including examination of three urine samples for albuminuria. This study aims to: 1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that the urinary proteome test identifies patients with a high risk for development of microalbuminuria. 2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment in a randomized double-blind, placebo-controlled multicenter study.

NCT ID: NCT02040259 Completed - Ischemic Stroke Clinical Trials

Trevo® Retriever Registry Post Market Surveillance

Start date: November 25, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

NCT ID: NCT02040051 Completed - Clinical trials for Intensive Care Units

Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)

NCT ID: NCT02039947 Completed - Clinical trials for Melanoma and Brain Metastases

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Start date: February 21, 2014
Phase: Phase 2
Study type: Interventional

This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

NCT ID: NCT02039921 Completed - HIV Clinical Trials

Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients

SWITCHART
Start date: October 2013
Phase: N/A
Study type: Observational

The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.