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NCT ID: NCT01913769 Active, not recruiting - Thoracic Neoplasms Clinical Trials

Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan

Start date: July 2013
Phase: N/A
Study type: Observational

Background: Chemoradiation is an important treatment strategy of locally advanced inoperable or unresectable disease. Radiation dose is an independent predictor of a pathological response. In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There have been sequential improvements in tumor localization, radiation planning and delivery over the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses associated with increased complications. However, heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The damage of the myocytes may lead to not only myocardial perfusion defects, but also in functional deterioration, or even in biomarkers. Since the impact of radiation-induced heart injury in patients with thoracic malignancies (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate of RT-related cardiac effects and clinical impacts. Objective: This study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies. Methods: The study plans to enroll thoracic cancer patients who will undergo local RT after complete staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image (MPI) at the time points of before and after RT. The results of MPI will be analyzed in qualitative visual interpretation of perfusion patterns, and functional quantitative data for cardiac functional parameters as well. The patients will be regular followed-up in CV OPD, following clinical judgement and guideline. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated. Expected results: We will obtain myocardial perfusion visual qualitative data in patients who received locoregional RT, respectively. These results will help in the understanding of pathophysiology, clinical management and follow-up of suspected RT-related heart disease.

NCT ID: NCT01907230 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

Start date: September 10, 2013
Phase: Phase 4
Study type: Interventional

Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection

NCT ID: NCT01897480 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Balise
Start date: August 28, 2013
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

NCT ID: NCT01856478 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Start date: May 23, 2013
Phase: Phase 3
Study type: Interventional

This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.

NCT ID: NCT01833611 Active, not recruiting - Chronic Hepatitis Clinical Trials

Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants. Out of range of clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers with persistently normal ALT and viral load more than 10^5 copies/mL have progression of liver disease during long-term follow-up. In addition, certain proportions of these patients do have significant inflammation and fibrosis in liver histology. This study will be able to identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding improvement of liver histology during short-term (1-year) and long-term ETV treatment (3-year).

NCT ID: NCT01823757 Active, not recruiting - Clinical trials for Focus on the Elderly in a Nursing Home

Pharmaceutical Care in VA Nursing Home

Start date: April 2013
Phase: N/A
Study type: Observational

This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are: 1. After patients receive pharmaceutical care, their drug related problems will be decreased. 2. After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.

NCT ID: NCT01817725 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg—a Pilot Study

Start date: March 2013
Phase: Phase 1
Study type: Interventional

Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level. Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml. Patients and methods: This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance. Aims 1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg. 2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients. 3. To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

NCT ID: NCT01788566 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

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

The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

NCT ID: NCT01787149 Active, not recruiting - Clinical trials for Combination With DMARDs

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis

Start date: September 2013
Phase: Phase 3
Study type: Interventional

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs versus DMARDs Alone in Patients with Rheumatoid Arthritis

NCT ID: NCT01778140 Active, not recruiting - Clinical trials for Radiographic Contrast Agent Nephropathy

Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System

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

The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with "Patient-Specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy.