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NCT ID: NCT02119494 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Phenotypes of COPD in Central and Eastern Europe

POPE
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess the representation of COPD patients in terms of categories and phenotypes of the disease in selected countries in Central and Eastern Europe (CEE). The results of The POPE study will allow for evaluation of the differences in clinical approaches and treatment practices. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

NCT ID: NCT02119143 Completed - Clinical trials for Immune System Diseases

Micronutrient Supplementation and Incidence of Common Cold

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

This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.

NCT ID: NCT02119039 Completed - Keratoconus Clinical Trials

Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

Start date: July 2014
Phase: Phase 4
Study type: Interventional

CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies. Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin. The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.

NCT ID: NCT02119026 Completed - Clinical trials for Metastatic Colorectal Cancer

Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer

PASSION
Start date: February 2011
Phase: Phase 2
Study type: Interventional

Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®) proved equivalence to 5-FU and is a well tolerated alternative combination partner for Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody bevacizumab (Avastin®). XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two different sequential treatment options with XELIRI/ XELOX in first and second line with the addition of bevacizumab and tries to give answer to the question if there is an optimal sequence for the benefit of the patient. This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who did not receive systemic treatment for their metastatic disease. The study is designed to evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab in terms of Duration of Disease Control (DDC). Patients will be treated with an established first line therapy consisting of either XELOX or XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given until disease progression, unacceptable toxicity or patient refusal. Capecitabine can be given in addition at the investigators' discretion until disease progression, unacceptable toxicity or patient refusal. If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued in first line treatment bevacizumab should be continued. In case of permanent discontinuation of bevacizumab for toxicities, chemotherapy should be continued. Upon completion of first line chemotherapy patients with disease control will receive bevacizumab maintenance treatment. On investigators decision patients can receive Capecitabine as additional maintenance treatment. The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on DDC. Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall response rate, time to response, duration of response, overall survival, tumor assessments (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination.

NCT ID: NCT02118896 Completed - Clinical trials for Kidney Transplantation

Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

Start date: February 24, 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

NCT ID: NCT02118545 Completed - Mortality Clinical Trials

Von Willebrand Factor to Predict Postoperative Outcome

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

vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of platelets and is released upon their activation. Endothelial cell dysfunction as well as platelet activation often occur in liver disease and portal hypertension, which may lead to an increase in circulating vWF levels. Indeed, multiple studies have reported that liver disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore, increased circulating vWF -Ag Levels have been shown to be associated with increased mortality rates in patients with chronic liver disease. Within a prospective evaluation cohort, the investigators were able to document that patients with increased vWF-Ag levels prior to liver resection suffered from an increased incidence of postoperative liver dysfunction and morbidity. Within this prospective multicenter validation study, the investigators now aim to prospectively validate that circulating vWF-Ag prior to liver resection is a valuable marker to predict postoperative clinical outcome.

NCT ID: NCT02116803 Completed - Solid Tumors Clinical Trials

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Start date: May 28, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.

NCT ID: NCT02112838 Completed - IGA Nephropathy Clinical Trials

Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

NCT ID: NCT02111577 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

VIABLE
Start date: May 26, 2014
Phase: Phase 3
Study type: Interventional

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

NCT ID: NCT02111564 Completed - Heart Failure Clinical Trials

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

MARINER
Start date: January 7, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.