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NCT ID: NCT01025765 Active, not recruiting - Chronic Hepatitis C Clinical Trials

The Effects of Oral Hypoglycemic Agents on Chronic Hepatitis C Patients Receiving Peg-Intron Plus Ribavirin

Start date: November 2009
Phase: Phase 4
Study type: Interventional

Pegylated interferon in combination with ribavirin is the current standard treatment of chronic hepatitis C virus infection, but is expensive and has several adverse effects. To modify this standard treatment by optimizing its therapeutic effect and decreasing its adverse events are important. Recent studies have identified a close link between metabolic profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in western world have have found beneficial effects of oral hypoglycemic agents on chronic Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in Taiwanese people remains unknown. The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents (daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1 infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin, Pioglitazone and standard care control groups). During the trial and 24 weeks after the end of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical data will be evaluated to determine the therapeutic response and adverse events of the CHC patients.

NCT ID: NCT01024894 Active, not recruiting - Hepatitis C Clinical Trials

Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy

ECLIPSE 3
Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

NCT ID: NCT00994123 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

NCT ID: NCT00992849 Active, not recruiting - Clinical trials for Corneal Neovascularization

Bevacizumab for the Treatment of Corneal Neovascularization

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

The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.

NCT ID: NCT00990860 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

START
Start date: February 2009
Phase: Phase 2
Study type: Interventional

TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the time to recurrence and progression. Performing TACE under sorafenib administration may have synergic effect on hepatic tumoral lesions.

NCT ID: NCT00982943 Active, not recruiting - Clinical trials for Psychiatric Disorders

The Epidemiological Study on Psychiatric Disorders and Psychotropic Drugs

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

During the past decade, the dramatic change in patterns of both psychiatric diagnoses and prescription of psychotropic agents has been noted since the introduction of newer antidepressant drugs. In the meantime, suicide has been recognized as a major public health problem all over the world. Research efforts have hence been spent in exploring the interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy for the treatment of depression). However, most available studies came from developed countries despite that the majority of countries with rising suicide rates during the past decade were developing countries. Both suicide rates and prescription of antidepressant agents have been rising in Taiwan during the past decade; with a reliable mortality registrar and nationwide health insurance covering 99% of its population, Taiwan is distinctive in realizing a large-scale analysis on these interrelationships between suicide and prescription of antidepressant drugs. However, there has been no study in Taiwan exploring these potential associations up to now. This study aims at examining the interrelationships between suicide rates and prescription of antidepressant agents based on the health insurance data from persons who had diagnoses of ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to 2006. The investigators plan to first perform correlation analyses between the trends of suicide rates and prescription of antidepressants during the study period after taking into accounts potential confounding factors; analyses by age, gender groups and by administrative regions will also be performed. Besides, the investigators plan to analyze the change in the prescription pattern of psychotropic agents in Taiwan during the study period, with the particular focus on that of newer antidepressant drugs. The prescription of psychotropic agents in both psychiatric and non-psychiatric diagnoses will be explored.

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: NCT00957086 Active, not recruiting - Clinical trials for Carcinoma, Squamous Cell of Head and Neck

Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

Start date: August 13, 2009
Phase: Phase 3
Study type: Interventional

The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.

NCT ID: NCT00931229 Active, not recruiting - Clinical trials for Non-Hodgkin's Lymphoma

Incidence of Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients

Start date: June 2009
Phase: N/A
Study type: Interventional

This is a single-arm study. Key eligibility criteria include (1) newly diagnosed, diffuse large B-cell or follicular cell non-Hodgkin's lymphoma; (2) negative test for hepatitis B surface antigen (HBsAg) and positive for antibody to hepatitis B core antigen (anti-HBc); (3) adequate bone marrow, liver, and kidney function. All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines. The primary endpoint of this study is the incidence of hepatitis B virus (HBV) reactivation, defined by a greater than 10-fold increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy and within 1 year after completion of the last course of rituximab-CHOP chemotherapy. Patients who have HBV reactivation during the study period will receive free entecavir treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks. The secondary endpoints include the incidence of hepatitis flare, defined as a greater than 3 fold increase of serum alanine aminotransferase (ALT) level that exceeded 100 IU/L, and the efficacy and safety of rituximab-CHOP chemotherapy. In the T1408 study we enrolled patients with newly diagnosed lymphoma who were HBsAg (-) and anti-HBc (+) and were to receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone)-based chemotherapy. Key findings of this study included (1) HBV reactivation, defined as a greater than 10-fold increase in HBV DNA compared with previous nadir levels, occurred to 10-20% of patients, depending on the sensitivity of the HBV DNA tests; (2) no HBV-related death with the prompt anti-viral therapy upon HBV reactivation; (3) patients with HBV reactivation were associated with poorer progression-free survival and overall survival; (4) serological breakthrough (i.e., re-appearance of HBsAg) is an important predictor of HBV-related hepatitis flare. In this amendment we will enroll more patients to clarify the above findings: (1) the association between HBV reactivation and survival; (2) diagnostic value of quantitative HBsAg and anti HBc tests on HBV reactivation; (3) whether host factors (DNA polymorphism) may help predict HBV reactivation. A larger patient cohort is needed to identify (1) baseline features that may help predict HBV reactivation, and (2) on-treatment features that may help timely anti-viral therapy.