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NCT ID: NCT01082367 Active, not recruiting - Clinical trials for Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

EARLY
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

NCT ID: NCT01071629 Active, not recruiting - Clinical trials for Chronic Heart Failure

Exercise Training Effects in Patients With Heart Failure

Start date: November 2004
Phase: N/A
Study type: Interventional

Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status. In patients suffering from CHF, exercise confers several beneficial effects on the cardiovascular and peripheral systems, mainly by continuous aerobic training. However, interval aerobic training has also been validated as an alternate form of training that increases the exercise capacity of patients who are in CHF. Recent studies have suggested that resistance training alone or as a complementary program besides the traditionally aerobic continuous training might exert favorable effects. However, little it is known about the combined effects of interval and strength training in CHF patients. Aim of this prospective randomized controlled study was to investigate the effects of combined interval and strength training comparing to interval training alone in CHF patients.

NCT ID: NCT01013740 Active, not recruiting - Cancer Clinical Trials

Lapatinib in Combination With Vinorelbine

VITAL
Start date: November 2009
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.

NCT ID: NCT00981058 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

SQUIRE
Start date: January 7, 2010
Phase: Phase 3
Study type: Interventional

The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

NCT ID: NCT00976989 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Patients With HER2-Positive Breast Cancer

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. Before surgery, patients will be randomized to receive either A) 6 cycles of pertuzumab plus Herceptin, with FEC (5-fluorouracil/epirubicin/cyclophosphamide) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus Herceptin with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus Herceptin with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv, then 6mg/kg iv 3-weekly, docetaxel at 75mg/m2 iv, increased to 100mg/m2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery patients will receive Herceptin 6mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.

NCT ID: NCT00935285 Active, not recruiting - Clinical trials for Ventilator-Associated Pneumonia

Ventilator-Associated Pneumonia (VAP) in Intensive Care Unit (ICU)

Start date: July 2009
Phase: N/A
Study type: Observational

Ventilator-associated pneumonia (VAP) is very common in the intensive care unit (ICU), affecting 9 to 40% of ICU patients and mortality rates range from 20 to 50% and may reach more than 70% when the infection is caused by multi-resistant and invasive pathogens. The most common pathogens that cause VAP are the Gram(-) bacteria. Findings indicate that TLRs serves as an important signal in the generation of protective innate responses to bacterial pathogens of the lung and that is required for effective innate immune responses against Gram-negative bacterial pathogens. There is genetic evidence that mutations in TLRs increase the risk of developing nosocomial infections. Understanding the TLR system should offer invaluable opportunity for manipulating host immune responses.

NCT ID: NCT00932243 Active, not recruiting - Clinical trials for Toll-Like-Receptors (TLRs)

Bacteremia in Intensive Care Unit (ICU)

Start date: July 2009
Phase: N/A
Study type: Observational

The presence of bacteremia and sepsis in percent of critically ill patients and none at all, associated with different expression and faction of Toll-Like-Receptors (TLRs.

NCT ID: NCT00882830 Active, not recruiting - Clinical trials for ICU Acquired Weakness (ICUAW)

Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)

Start date: September 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.

NCT ID: NCT00880802 Active, not recruiting - Clinical trials for Acute Coronary Syndromes

Finding Acute Coronary Syndromes (ACS) With Serial Troponin Testing for Rapid Assessment of Cardiac Ischemic Symptoms

FAST-TRAC
Start date: December 2008
Phase: N/A
Study type: Observational

Study Objectives The following items will be prospectively assessed. Primary Endpoints 1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high sensitivity-cardiac Troponin I (hs-cTnI) provides improved diagnostic accuracy for ACS (including Acute Myocardial Infarction (AMI) and/or Unstable Angina (UA)) within the first two (2) hours after emergency department presentation when compared to currently available troponin assays. 2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved prognostic information with regard to 180 day event rates of Major Adverse Cardiac Event outcomes, including cardiac deaths which are defined as all deaths except those that are clearly non-cardiac in nature (e.g. trauma), when compared to a currently available troponin assay. Secondary Endpoints 1. For patients presenting with clinical suspicion of ACS, using the rate of rise of hs-cTnI over time between presentation and 2 hours (delta hs-cTnI) allows for the differentiation between ACS and other disease states. 2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved sensitivity for detecting AMI within the first two (2) hours after presentation when compared to a currently available troponin assay. 3. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved negative predictive value for ruling out ACS (AMI or UA) within the first 2 hours after presentation when compared to a currently available troponin assay. 4. For alternative endpoints of cardiac mortality, and for alternative censor time points of 30 days, 90 days, and 1 year, hs-cTnI provides improved prognostic information when compared to the currently available troponin assay. 5. In cases where the emergency physician has limited diagnostic confidence, hs-cTnI AMI diagnostic accuracy will be superior to local hospital standards for AMI determination. 6. In cases where the emergency physician has limited diagnostic confidence, the slope for the hs-cTnI between presentation and 2 hours will add diagnostic accuracy for ACS diagnosis over and above local hospital standards for ACS determination. 7. For patients presenting with clinical suspicion of ACS, the difference in diagnostic accuracy for ACS (including AMI and/or UA) using hs-cTnI measurement from time of onset of symptoms to emergency department presentation (e.g. 3 hours instead of 6 hours) will be evaluated to assess any variation.

NCT ID: NCT00788762 Active, not recruiting - Glaucoma Clinical Trials

Myocilin Variations and Familial Glaucoma in Taxiarchis

Taxiarchis
Start date: August 2007
Phase:
Study type: Observational

Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have a surprisingly high incidence of glaucoma. This isolated population located on Mount Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation in the Greek population,the investigators undertook a community-based study to determine if this variant was present in this village.