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NCT ID: NCT01438814 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

NCT ID: NCT01437566 Completed - Breast Cancer Clinical Trials

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

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

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

NCT ID: NCT01428921 Completed - Clinical trials for Sleep Apnea, Obstructive

Long Term Efficacy of Education Programme on Continuous Positive Airway Pressure Treatment

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

Obstructive sleep apnea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. Successful CPAP treatment has also been shown to improve cognitive, cardiovascular and metabolic function. Sustainable CPAP treatment would alleviate the substantial cost burden of health-related consequences of untreated OSA. However, the use of CPAP for such patients is disappointingly low and limits the effectiveness of treatment. Early CPAP education and follow up have shown to be very important in helping subjects to handle side-effects or problems associated with the use of CPAP. Good education program at the initial phase of using CPAP is essentially affected the acceptance and adherence of CPAP therapy. Good CPAP adherence is not only medically essential to patients' health but also economically importance to society by alleviating the substantial cost burden of health-related consequences. To the best of our knowledge, there is no randomized clinical trial (RCT) to prove the long-term efficacy of extended education program on improving continuous positive airway pressure use and its treatment outcomes. The primary purpose of this study is to assess the long-term efficacy of our on-going RCT which is an extended education program on improving CPAP compliance. The investigators hypothesize that the application of both MI technique and SCT-based extended education program at the initial phase of using CPAP also would enhance CPAP adherence even after one year of attending education class.

NCT ID: NCT01425723 Completed - Severe Hemophilia B Clinical Trials

Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

B-YOND
Start date: December 8, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

NCT ID: NCT01414075 Completed - Anemia Clinical Trials

Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Start date: July 21, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.

NCT ID: NCT01408576 Completed - Clinical trials for Systemic Lupus Erythematosus

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

EMBODY4
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01408186 Completed - Clinical trials for Upper Gastrointestinal Bleeding

ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA

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

Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to the investigators hospital that serves a local population of 1.5 million. In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a major dilemma. In another double-blind randomized trial, the investigators have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks. In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the dominant preventive strategy. Given the vast number of people taking ASA, however, it is only cost-effective to identify and treat those who are at high risk of ulcer bleeding and who have a strong indication for ASA use. Data from observational studies and randomized trials have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding associated with ASA. Other potential preventive strategies include eradication of H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with misoprostol or H2RAs.

NCT ID: NCT01400503 Completed - Clinical trials for Multicentric Castleman's Disease

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

Start date: April 1, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

NCT ID: NCT01397890 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

SECURE 1
Start date: July 2011
Phase: Phase 4
Study type: Interventional

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01395745 Completed - Clinical trials for Systemic Lupus Erythematosus

CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

CHABLIS-SC1
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.