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NCT ID: NCT01606397 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

Start date: March 2008
Phase: Phase 1
Study type: Interventional

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes : - The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses - How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks - How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal - How LY2409021 works when given with metformin - How daily dosing of LY2409021 affects the cells that produce insulin

NCT ID: NCT01606371 Completed - Clinical trials for Diabetes Mellitus, Type 2

A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes

Start date: May 2007
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.

NCT ID: NCT01602315 Terminated - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Start date: November 12, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab: Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719. The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3. Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.

NCT ID: NCT01601288 Completed - Dyspnea Clinical Trials

Database of All Patients Who Have Undergone Pulmonary Function Testing at Singapore General Hospital

Start date: May 2012
Phase:
Study type: Observational

The purpose of this study is to create a prospective database of all patients who have undergone pulmonary function testing from which the investigators can study the clinical phenotypes of various respiratory conditions. The investigators hope by understanding the differences in these myriad phenotypes to be able to provide individualized, patient-targeted therapy in the future.

NCT ID: NCT01601275 Completed - Tuberculosis Clinical Trials

Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection

Start date: May 2012
Phase:
Study type: Observational

Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital.

NCT ID: NCT01600378 Recruiting - Clinical trials for Diffuse Parenchymal Lung Diseases

Prospective Data Collection of Patients With Diffuse Parenchymal Lung Diseases

Start date: May 2012
Phase:
Study type: Observational

The purpose of this study is to generate a prospective database of all patients evaluated for diffuse parenchymal lung diseases to provide much needed data on the various disease aetiologies, incidence and prevalence rates, clinical and radiological presentations, pathologic correlations, disease progression and response to treatment, and final outcomes in this group of patients in Singapore.

NCT ID: NCT01600352 Completed - Clinical trials for Interstitial Lung Disease

Specific Autoantibody Testing in Patients With Interstitial Lung Disease

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

The purpose of this study is to evaluate the clinical utility of specific autoantibody testing in unmasking an underlying connective tissue disorder in patients who present with interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease.

NCT ID: NCT01599377 Completed - Healthy Clinical Trials

Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.

NCT ID: NCT01597739 Completed - Clinical trials for Arthritis, Rheumatoid

A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

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

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.

NCT ID: NCT01596452 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Enumeration of Circulating Tumour Cells (CTCs) in Patients With Advanced Solid Malignancy Using Complementary Metal Oxide Semiconductor (CMOS) Technology

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

Modern anti-cancer treatments are focused on development of molecular based therapies i.e. specific treatments targeted against underlying biological processes. There is still much to learn about the biology of cancer, especially in tumours such as colorectal and lung cancer where it is likely multiple heterogenous signaling pathways are responsible for progression of disease. This project aims to evaluate circulating tumour cells (CTCs) as a surrogate biomarker for tumour characteristics and to determine how they may used to identify new targets for therapeutic agents. Their use could be applied to diagnosis of cancer, prediction of response to therapies and prognosis, ultimately across a broad range of tumour types. Currently the only way to investigate molecular features of a cancer is through procurement of an invasive tumour biopsy that is often difficult to obtain, often results in insufficient material and is unpleasant for the patient. A blood-based test would provide a much more practical and patient friendly alternative. The enumeration and molecular characterisation of CTCs has the novel potential of being a "virtual biopsy" of the tumour and offers the opportunity for immediate therapeutic decisions (eg. if the tumour develops a therapy resistant genotype while on treatment). CTCs have been known to circulate in bloodstream of cancer patients for many years and are known to lead to cancer metastases. They have been very difficult to detect, up until recently, due to the complexity of the metastatic process and detecting relatively small numbers of CTCs amongst billions of red and white blood cells. However, technology has moved on dramatically in the last few years. The FDA approved CellSearch platform (Veridex, NJ) can isolate and enumerate CTCs based on the immunomagnetic capture of EpCAM (epithelial cell adhesion molecule) positive cells. Several studies have recently demonstrated the value of CTC enumeration in reflecting prognosis and predicting early response to systemic chemotherapy. For example, in a study comprising 456 patients with metastatic colorectal cancer starting a new line of therapy, patients with =3 CTCs per 7.5 ml blood at baseline had shorter progression free survival (PFS) and overall survival (OS) compared to those patients with < 3CTCs at baseline (PFS 4.5 versus 7.9 months P=0.0001; OS 8.5 versus 19.1 months P=0.0000 respectively). Overall survival for patients converting to or maintaining CTCs =3 within a few weeks of commencing systemic therapy remained worse than for those patients maintaining CTC counts < 3 per 7.5ml blood. Similar results have been reported in patients with breast and hormone refractory prostate cancer (HRPC). These studies have led to FDA approval of the CellSearch system as an adjunct to monitoring patients with these 3 tumour types. The CellSearch platform, however, does not allow for the downstream DNA analysis of captured cells and the ferroparticle-coated CTCs are non-viable. Furthermore, this platform is a multi-machine, multi-kit system that is laborious (typical 3-7 days turnover time), expensive (USD 650), and subject to operator variance. In this protocol, the investigators propose for the first time, an automated, fully quantitative system for isolation and enrichment of CTCs. The key differentiating feature of our novel CMOS system is the electrochemical identification and counting of tumour cells using a high density electrode array with associated electronics for addressing the electrodes. This leads to a standardized assay for tumour cells with a shorter turnover time and without the need of a skilled operator. This system also holds the potential for allowing the molecular characterization of CTCs. This study aims to enumerate CTCs using a novel CMOS technology in patients with metastatic cancer who are scheduled to receive palliative chemotherapy, and to correlate CTC number with clinical outcome. In Part I of the study, the investigators will recruit 10 patients with metastatic NSCLC and 10 patients with metastatic CRC in order to assess the feasibility of CTC enumeration in patients. In particular, the investigators aim to establish whether CTCs are detectable using the novel CMOS technology in patients with metastatic cancer. In Part II of the study, the investigators will recruit 21 patients with metastatic NSCLC and 89 patients with metastatic CRC in order to compare CTC counts as determined by the CMOS technology with CTC counts as determined by the CellSearch platform. Blood samples will be collected at a single time point prior to the start of palliative chemotherapy. CTC numbers will be correlated with clinical outcome in all evaluable patients. The investigators hypothesize that CTC enumeration by a novel CMOS technology is non-inferior to CTC enumeration by the CellSearch platform in patients with advanced solid malignancies.