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NCT ID: NCT01638520 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Safety and Efficacy of Blocking IL-4 With Pascolizumab in Patients Receiving Standard Therapy for Pulmonary Tuberculosis

Start date: June 2012
Phase: Phase 2
Study type: Interventional

New approaches are needed to achieve more rapid elimination of dormant mycobacteria and thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key cytokine in the immune response to TB that may impair the clearance of mycobacteria. We hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an adjunct to standard treatment. The aims of this trial are to determine whether administration of pascolizumab as an adjunct to standard combination treatment for drug-sensitive TB produces changes in one or more parameters of bacterial or host response (including bacterial clearance, host clinical status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously demonstrated in healthy volunteers and patients with asthma) in patients with TB.

NCT ID: NCT01621438 Active, not recruiting - Clinical trials for Multivessel Coronary Artery Disease

Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

Start date: May 2012
Phase: N/A
Study type: Observational

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

NCT ID: NCT01587443 Active, not recruiting - Hemodialysis Clinical Trials

Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population

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

End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is affected by ESRD and/or its treatment, and has been increasingly used as an outcome measure in interventional studies. Additionally, associations between social support and QoL have been observed, indicating that improved social support could improve HRQoL, morbidity and mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social support between HD and PD patients in the multiethnic society of Singapore have not been evaluated. As such, the investigators propose to conduct this cross-sectional study in the investigators local multiethnic ESRD patient population to evaluate and compare patient-reported outcomes (HRQoL and social support), economic and clinical laboratory outcomes in HD and PD patients. All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in this cross-sectional, observational study. Information on patient demographics, medical/medication histories, dialysis vintage, clinical laboratory data and associated medical costs will be obtained from clinic notes, electronic medical records and hospital databases. Patient-reported outcomes will be determined from scores of the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological Distress Scale and Health Services Utilization questionnaires (for indirect costs), and compared between HD and PD patients. Results from this study will provide important HRQoL information to assist renal physicians and patients to make treatment decisions. Furthermore, intervention programs could be developed to improve social support based on patients' needs. These could in turn improve patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.

NCT ID: NCT01460472 Active, not recruiting - NSCLC Clinical Trials

Immunotherapy With Racotumomab in Advanced Lung Cancer

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.

NCT ID: NCT01368588 Active, not recruiting - Prostate Cancer Clinical Trials

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Start date: July 2011
Phase: Phase 3
Study type: Interventional

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

NCT ID: NCT01349322 Active, not recruiting - Breast Cancer Clinical Trials

Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

Start date: May 2011
Phase: Phase 3
Study type: Interventional

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

NCT ID: NCT01341834 Active, not recruiting - Clinical trials for Nasopharyngeal Carcinoma, Lymphomas, Any EBV+ Solid Tumour

Safety and Tolerability Study of RAD001 and LBH589 in All Solid Tumors With Enrichment for EBV Driven Tumors

Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is: 1. To determine the optimal recommended phase II dose of two investigational study drugs, LBH589 and RAD001, given in combination in all solid tumors (With enrichment for EBV-Driven tumors). 2. To determine the pharmacokinetic profile of RAD001 in combination with two schedules of LBH589. 3. To assess the preliminary anti-tumor activity of RAD001 and LBH589. This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the effects of key viral proteins, and switch the virus from a latent proliferative phase to a lytic phase. Immunologic correlates will also be examined to ascertain T-cell subpopulations and expression of HLA class molecules. DCE-MRI will be subsequently employed in dose expansion to examine antiangiogenic effects.

NCT ID: NCT01309607 Active, not recruiting - Clinical trials for ErbB2-Positive Stage I-III Breast Cancer

Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic erbB2-positive breast cancer. Secondary objectives include: - To determine the safety and tolerability of weekly paclitaxel and carboplatin, combined with lapatinib, in an Asian population - To determine breast conservation rates following neoadjuvant paclitaxel/ carboplatin/ lapatinib - To determine clinical response rates and relapse-free survival of patients treated with neoadjuvant paclitaxel/ carboplatin/ lapatinib - To identify predictive tumour biomarkers for pathologic complete response The investigators hypothesize that pathologic complete response rates will be improved from 15% to 35% with the neoadjuvant regimen of carboplatin/ paclitaxel/ lapatinib compared to standard chemotherapy alone in HER2 positive early stage breast cancers.

NCT ID: NCT01247480 Active, not recruiting - Breast Tumor Clinical Trials

Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Tumor Specimens in Breast Cancer

Start date: September 2010
Phase: N/A
Study type: Observational

Major Aims of study: 1. To create a gene expression-based prognostic device that complements or exceeds the prognostic utility of conventional biomarkers of breast cancer outcome. 2. To identify one or more clinical subgroups of patients for which the prognostic device outperforms, or substantially adds to, the prognostic performance of conventional markers that currently determine therapeutic strategies. Sub-Aims of study: 1. Assess the prognostic value of the multiple gene expression signatures, alone and in combination, using a large cohort of breast cancer patients for which pathology, treatment and outcome is available. A "training" and "testing" design is proposed. 2. Evaluate the utility of a prognostic device that measures gene expression levels from formalin-fixed paraffin-embedded specimens (FFPEs) of primary resected tumors. The investigators will utilize the Affymetrix Quantigene 2.0 Assay and/or the Illumina BeadXpress VeraCode DASL Gene Expression Assay (FDA-approved IVDMIA.) 3. For specific clinical subgroups of patients/tumors, the investigators will mathematically identify additive or synergistic prognostic relationships between genes and gene signatures that, in combination, will yield maximal risk prediction (distant metastases-free survival) for patients. 4. Compare the prognostic utility of the investigators device to that of the conventional prognostic variables that are currently used to determine therapeutic strategy. 5. Incorporate the prognostic signatures into a practical prognosis algorithm that seeks to include conventional measures of outcome such as tumor size, histologic grade, nodal status, patient age, or Nottingham index, etc. The investigators hypothesize that adequate quality and quantity of tumor RNA may be extracted from archival paraffin-embedded tumor specimens for gene expression profiling, and that archival tumor-derived genomic signatures may be used as prognosticators or predictors in breast cancer.

NCT ID: NCT01247467 Active, not recruiting - Breast Tumor Clinical Trials

Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study

Start date: August 2010
Phase: N/A
Study type: Observational

A number of prognostic and/or predictive genomic signatures for breast cancer have been developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene signatures and compare them with conventional clinical prognosticators and predictors. As the investigators plan to use archival tumor samples that dates back to the 1990s, the aim of this pilot study is to first analyze 10 anonymized samples to determine the feasibility of running these assays on old archival blocks. The information generated will help us determine whether very old samples (diagnosed before 2000) may be selected for the actual study.