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NCT ID: NCT01915589 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 16, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

NCT ID: NCT01915082 Completed - Clinical trials for Disorder Related to Lung Transplantation

Peri-operative Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation

AZI003
Start date: September 2013
Phase: Phase 4
Study type: Interventional

This study investigates possible beneficial effects of peri-operative treatment (i.e. pre-transplant initiation and prompt post-transplant continuation) with azithromycin in lung transplantation. Our hypothesis is that this therapy will improve early allograft function and outcome following human lung transplantation.

NCT ID: NCT01914549 Completed - Clinical trials for Supraventricular Tachycardia

Dipole Density Mapping of Supraventricular Tachycardia

DDRAMATIC-SVT
Start date: April 2015
Phase: N/A
Study type: Interventional

Use of dipole density mapping to identify activation in complex supraventricular tachycardias

NCT ID: NCT01914367 Completed - Clinical trials for Infection With Human Papillomavirus

Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)

HPVXneutra001
Start date: June 25, 2013
Phase: Phase 4
Study type: Interventional

Six identical female twins aged 9-13 years will participate. One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will be taken (the first prior to vaccine administration, the second and third 7 days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either Cervarix or Gardasil will be examined. The duration of the study is approximately 187 days. Five study visits will take place, over a time period of 6.5 months, followed by a telephone call after 12 months. The purpose of the study is to learn more about the molecular mechanisms underlying the cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).

NCT ID: NCT01913977 Completed - Clinical trials for Respiratory Acidosis

Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System

Start date: February 20, 2014
Phase: N/A
Study type: Interventional

This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome) treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2 (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy). The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication for anticoagulation therapy. Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h. A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL) are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG) 1.5, 3, 6, 7, 8L/min Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).

NCT ID: NCT01913873 Completed - Clinical trials for Myocardial Infarction

High-sensitivity Troponin in Cardiac Surgery

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

Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction. Postoperative heart infarction remains a frequent and important complication after heart surgery.Therefore it is important to recognize any cardiac event in patients who underwent heart surgery. Although different diagnostic tools can be used to recognize these events, few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction after heart surgery. In this study the investigators will describe the concentration changes of those cardiac biomarkers over time in patients undergoing heart surgery, and the investigators will try to establish a upper level value who could indicate heart infarction.

NCT ID: NCT01913652 Completed - Clinical trials for Dedifferentiated Liposarcoma

Ph II Cabazitaxel DD Liposarcoma

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

Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.

NCT ID: NCT01913613 Completed - Heart Failure Clinical Trials

REDUCE LAP-HF TRIAL

REDUCE LAP-HF
Start date: September 2013
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

NCT ID: NCT01913184 Completed - Healthy Subjects Clinical Trials

Lung Bioavailability With Continuous or Discontinuous Nebulization

Start date: April 2012
Phase: N/A
Study type: Interventional

To compare the continuous and sicontinuous delivery of drug with AKITA.

NCT ID: NCT01911624 Completed - Clinical trials for Staphylococcus Aureus Bacteraemia

Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia. The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.