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NCT ID: NCT01383967 Completed - Bipolar Disorder Clinical Trials

A Study of LY2979165 in Healthy Subjects

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is a two part study. Part A is a multiple-ascending dose study in up to 6 different groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will allow investigation of up to 6 different doses of LY2979165. The drug will be administered for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from Day -1 (the day before dosing) until Day 15. Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12 subjects. The drug will be administered for a total of 14 days. In addition to the same assessments as would have been completed in Part A, subjects in Part B will also have cerebrospinal fluid samples taken from the lower lumbar region of their spine.

NCT ID: NCT01379690 Completed - Type 2 Diabetes Clinical Trials

Retrospective Study: Hip Fractures in Diabetic Patients

Start date: April 2011
Phase: N/A
Study type: Observational

Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic complications including retinopathy and neuropathy, and also as a result of hypoglycaemic therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM patients . Increased fall risk may explain why T2DM patients are at increased risk of hip fractures , despite having a higher bone mineral density as compared to non-T2DM patients. Given the high morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip fractures , all care must be given to prevent hip fractures in T2DM patients. There is controversial data on T2DM medications and fracture risk. Vestergaard showed that use of metformin and sulphonylureas decreased the risk of all fractures, while there was there was a similar trend with insulin. The present study sought to evaluate the relationship between A1c values and the risk of fractures in treated patients with T2DM.

NCT ID: NCT01376479 Completed - Clinical trials for Hand, Foot and Mouth Disease

Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).

NCT ID: NCT01374542 Completed - Clinical trials for Respiratory Tract Infections

Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Start date: June 2011
Phase:
Study type: Observational

Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy. The diagnostic yield, technical factors and complications for all patient sub-populations is still not clearly defined. This may result in inappropriate or even dangerous application of such procedures. The aim of the study is to collect data on these aspects of respiratory endoscopy and identify important trends, as well as, areas for improvement. This data will also provide baseline comparative data for new bronchoscopic techniques such as endobronchial ultrasound and navigational bronchoscopy. Method: Prospective data collection. Technical details regarding these procedures are currently keyed into the OTM system by the endoscopy operators for documentation and billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of all the fields from the OTM system for audit purposes.(See data collection form) The research project proposes to make the data non identifiable by removing the patient's name and IC number. Additionally the yield of the procedure will be checked by a chart review of the histology and microbiology results. There are no restrictions on patient recruitment because all procedures will be performed for clinical indications only and no patient will be recruited for the sole purpose of the study. Waiver of consent has been approved by the IRB.

NCT ID: NCT01374178 Completed - Diabetes Mellitus Clinical Trials

A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.

NCT ID: NCT01374139 Completed - Clinical trials for Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).

NCT ID: NCT01372085 Completed - Clinical trials for Healthy Participants

Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This is a single-centre, placebo-controlled, two-part study in healthy participants. Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.

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: NCT01365481 Completed - Hypertension Clinical Trials

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

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

The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.

NCT ID: NCT01363232 Completed - Clinical trials for Advanced Solid Tumors

Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162. Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.