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NCT ID: NCT02207530 Completed - Clinical trials for Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck

Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: October 23, 2014
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

NCT ID: NCT02194673 Completed - Healthy Clinical Trials

Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response

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

Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (TFPM).

NCT ID: NCT02192047 Completed - Overweight Clinical Trials

Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

Start date: September 2012
Phase: N/A
Study type: Interventional

The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.

NCT ID: NCT02189135 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

Making Ramadhan Fasting a Safer Experience With Technology Study

Start date: July 2014
Phase: Phase 4
Study type: Interventional

Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.

NCT ID: NCT02176278 Completed - Clinical trials for Diabetic Kidney Disease

Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT)

DKD-TMT
Start date: June 2014
Phase: N/A
Study type: Interventional

In this quality improvement program (DKD-TMT), patients will be recruited from multiple sites across Asia, with each site recruiting at least 300 type 2 diabetic patients with Diabetic Kidney Disease (DKD). After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to the UC (n=100, usual care) group, the EC (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group. Patients in all 3 groups will undergo a comprehensive assessment (CA) guided by the templates in the Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12. They will also self-administer a set of questionnaires for assessing quality of life and psychological distress during the CA at both time points. During the 12 months between the 2 CAs: - Patients in the UC group will receive UC in accordance to the practice of the health institution. - Patients in the EC group will receive a JADE summary report with personalized risk prediction, treatment targets and decision support with explanation from the doctor and nurse. In addition to receiving UC in accordance to the practice of the health institution, the nurse will telephone the patient 3-monthly to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns. - Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets, but tailored to patients' risk profile. The patients will receive telephone reminders and also be given a JADE follow up report 3-monthly. The primary composite endpoint is attainment of treatment goals and/or control of risk factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The tertiary changes are behavioral changes, psychological well-being and quality of life.

NCT ID: NCT02174627 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

NCT ID: NCT02172950 Completed - Hemophilia A Clinical Trials

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

Start date: October 13, 2014
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

NCT ID: NCT02171429 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS II
Start date: November 14, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naIve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28948; NCT02163759) was independently conducted.

NCT ID: NCT02159846 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Mixed Herbs on Blood Glucose and Lipid Profile in T2DM Patients

T2DM
Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study was to evaluate the effects of mixed herbs as ad-on therapy on blood sugar and lipid profile of patients with established T2DM. A total 20 patients were consented and were equally divided into the Control and the Test groups and was fed with the Placebo or mixed herbs 4 g daily for 30 days, respectively. Blood samples were collected before and at the end of the feeding period and analyzed for the parameters namely Fasting Blood Sugar (FBS), 2 hours post prandial (2HPP) Glycosylated Hb (HbA1c) and Lipid Profile. The collected data was analyzed using SPSS Statistical Software version 12.

NCT ID: NCT02144012 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of patients with HER2-positive metastatic breast cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite primary multimodality therapy, and/or metastatic BC if they have not received prior chemotherapy for their metastatic disease. Eligible patients at up to approximately 40 sites in the Asia-Pacific region will be randomized in a 2:1 ratio to receive trastuzumab emtansine (Arm A) and will receive trastuzumab plus docetaxel (Arm B). All study drugs will be administered at in-clinic visits occurring every three weeks during the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it represents a common first-line treatment option used in this patient population in China and other Asia-Pacific countries.