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NCT ID: NCT01248052 Completed - Bipolar Disorder Clinical Trials

A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers

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

This is a two part study (Parts A and B), the purpose of which is to determine the safety of LY2979165 in healthy people, and any side effects that might be associated with it, and to understand how the body handles LY2979165. In addition, Part B, will also look at levels of LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.

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.

NCT ID: NCT01247441 Recruiting - Breast Cancer Clinical Trials

Breast Cancer Registry - National University Health System, Singapore

Start date: n/a
Phase: N/A
Study type: Observational

The Breast Cancer Registry aims to collect clinical data of all breast cancer patients diagnosed and/or treated in the National University Hospital, with the goal of understanding risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer in Singapore. This information will contribute to improving management of breast cancer patients.

NCT ID: NCT01247363 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of LY2608204 in Patients With Type 2 Diabetes

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

Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes. Study subjects will receive once daily doses of LY2608204 for a total treatment duration of up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until reaching the highest dose that they can tolerate. Continuous glucose monitoring devices will be employed for each patient to monitor for hypoglycemia during study treatment. Dose titration and dose reduction is determined for each individual patient based on their safety and glycemic data.

NCT ID: NCT01246362 Completed - Knee Osteoarthritis Clinical Trials

Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty

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

The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing post-operative pain and improving function outcome after a total knee arthroplasty.

NCT ID: NCT01244620 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

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

Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor). Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.

NCT ID: NCT01241591 Completed - Psoriasis Clinical Trials

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

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

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

NCT ID: NCT01238679 Terminated - Healthy Volunteers Clinical Trials

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

Start date: November 24, 2010
Phase: Phase 1
Study type: Interventional

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

NCT ID: NCT01235195 Completed - Healthy Clinical Trials

A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions

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

This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.