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NCT ID: NCT01585818 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Dietary Intervention in Diabetes Mellitus (DIDM)- Intermediate and Acute Effects

DIDM
Start date: August 2011
Phase: Phase 2
Study type: Interventional

Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally accepted as the cornerstone for the treatment of people with type 2 diabetes mellitus (T2DM). Consumption of low glycaemic index (GI) meals have been shown to improve glycaemic control, lipid profile and reduced systemic inflammation. However, these studies and international evidence-based nutritional recommendations are principally based on people of European ethnicity consuming fairly typical "western" diets. There are few published controlled dietary intervention studies which have attempted to determine appropriate dietary patterns for the treatment of diabetes amongst populations consuming rice-based diets. HYPOTHESIS 1. The glycaemic response over 6 days as measured by CGMS will have a lower mean glucose level and postprandial increase in individuals consuming the LGI compared with the SDI meal plan. 2. A LGI meal plan is acceptable and participants will adhere and comply to the diet to the same level as those receiving the SDI meal plan. 3. Glycaemic and metabolic parameters as measured by integrated area under the curve (IAUC) of glucose and insulin are lower after a single meal comprising of LGI than compared with an SDI meal. 4. The effect of a single meal of LGI reduces appetite and increases satiety compared with a meal of SDI.

NCT ID: NCT01583218 Completed - Clinical trials for Venous Thromboembolism (VTE)

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

APEX
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

NCT ID: NCT01582230 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

NCT ID: NCT01580293 Completed - Hemophilia A Clinical Trials

A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A

PROTECT-VIII
Start date: April 23, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability. The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A. 120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary. Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

NCT ID: NCT01572727 Completed - Breast Cancer Clinical Trials

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

BELLE-4
Start date: August 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

NCT ID: NCT01570439 Recruiting - Clinical trials for Anonymous Donors at Blood Donation Center (NUH)

To Identify HLA-A1101-restricted Peptide Epitopes Derived From Novel Oncoantigens (URLC10, KIF20A, and CDCA1) Applicable for Cancer Vaccine in Singapore

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

Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore. Methods: The panel of candidate peptides are synthesized and tested for their ability to induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable for the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell pulsed with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes were negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for their peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These conditions are completely performed in in-vitro system. Importance in medicine: If one could identify the peptide epitopes from novel Oncoantigens, it is applicable for clinical trials of cancer vaccination. Benefits & Risks : There is no risk except for the matter of venipuncture in each individuals. The ideal target molecules for cancer vaccination are thought to be selectively expressed in tumor cells, but not in the normal cells, with high frequent and homogenous expression within tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these characters as ideal target molecules for the cancer vaccination and are highly expressed in a variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101 haplotype is most frequent in Singaporean, it is essential to indentify the HLA-A1101-restriced peptides derived from these Oncoantigens to develop cancer vaccination.

NCT ID: NCT01570296 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Trial of Gefitinib in Combination With BKM120 in Patients With Advanced Non-Small Cell Lung Cancer, With Enrichment for Patients Whose Tumours Harbour Molecular Alterations of PI3K Pathway and Known to Overexpress EGFR

BKM120
Start date: October 3, 2011
Phase: Phase 1
Study type: Interventional

The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib and BKM120 will be determined.

NCT ID: NCT01568866 Completed - Multiple Myeloma Clinical Trials

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients

ENDEAVOR
Start date: June 20, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

NCT ID: NCT01568801 Completed - Frail Elders Clinical Trials

Evaluation of the Singapura Program of All Inclusive Care for the Elderly (SingaPACE) Demonstration Project

SingaPACE
Start date: August 2011
Phase: N/A
Study type: Interventional

This is a RCT studying the effectiveness of the Singapore Program for All Inclusive Care for the Elderly (SingaPACE) demonstration project over a 36 month period. SingaPACE is modelled on the US PACE home and community based service that acts as an alternative to institutional care. The comparator is best referrals for care as currently arranged through the Agency for Integrated Care (AIC) and referred by medical social workers. This research aims to determine how the SingaPACE model of health and social care affects use of emergency and acute care hospital services, institutional care, the quality of life (QOL) and satisfaction of the participants aged 60+ and their caregivers. The hypotheses to be tested are: H01: The elderly in SingaPACE will have fewer admissions to accident & emergency (A&E) hospitalization than the elderly who are not in SingaPACE. H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than the elderly who are not in SingaPACE. H03: The elderly in SingaPACE will delay first admission to institutionalized nursing home care more than the elderly who are not in SingaPACE. H04: The elderly in SingaPACE clients will have a higher QOL compared to the elderly who are not in SingaPACE. H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to caregivers of the elderly who are not in SingaPACE.

NCT ID: NCT01568216 Terminated - Schizophrenia Clinical Trials

20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

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

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.