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NCT ID: NCT01737697 Completed - Hyperkalemia Clinical Trials

Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

Start date: November 30, 2012
Phase: Phase 3
Study type: Interventional

Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).

NCT ID: NCT01736540 Completed - Clinical trials for Thalassemia, NTDT, MDS, MF, Other Anemia

An Epidemiological Study to Assess Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)

Start date: February 2013
Phase: N/A
Study type: Observational

Iron, one of the most common elements in nature and the most abundant transition metal in the body, is readily capable of accepting and donating electrons. This capability makes iron a useful component of various, essential biochemical processes. Despite the essential role of iron, the excess of iron is toxic to the human body. It is critical for the human body to maintain iron balance, since humans have no physiologic mechanism for actively removing iron from the body. The development of iron overload occurs when iron intake exceeds the body's capacity to safely store the iron in the liver, which is the primary store for iron. Long-term transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is currently the most frequent cause of secondary iron overload. The mounting evidence regarding the mortality and morbidity due to chronic iron overload in transfusion dependent anaemias has led to the establishment of guidelines that aim the improvement of patient outcomes. Further prospective studies are warranted in order to assess the impact of iron overload in patients with acquired anaemias. In this study, non-invasive R2- and T2*-MRI techniques will be applied to the liver and the heart, respectively, to complement the primary variable (serum ferritin) assessed in patients with various transfusion-dependent anaemias. The main objective of this study is to assess the prevalence and severity of cardiac and liver siderosis in patients with transfusional siderosis. This study will also aim to establish possible correlations between cardiac and liver iron levels with clinical effects in patients with different transfusion-dependent anaemias. Patients will be eligible for enrollment irrespective of receiving chelation therapy or not (and irrespective of the chelating agent used).

NCT ID: NCT01736475 Completed - Hemophilia A Clinical Trials

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Start date: January 31, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

NCT ID: NCT01735448 Completed - Tobacco Dependence Clinical Trials

Improving Health for Aboriginal People Through Tobacco Related Research

Start date: March 2013
Phase: N/A
Study type: Observational

Aim: To identify barriers and facilitators in the uptake of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held health priorities and barriers to research in Aboriginal Australians from the perspectives of: - Aboriginal smokers and ex/non-smokers - Aboriginal Healthcare workers - Consultants/general practitioners, and - Key stakeholders in Aboriginal health Focus groups, one-on-one interviews and surveys will be conducted to provide information at the 'grass-roots' level including examinations into perceived differences in locally held beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs, to assist implementation of future tobacco cessation/prevention interventions and treatment of smoking related illnesses. This information can be used to improve the health of Aboriginal people by identifying inadequacies in current practices and highlighting what these are through the eyes of community members, healthcare workers, consultants/general practitioners and key stakeholders. We also intend on examining any facilitators that are identified as positive and working aspects of current initiatives e.g. community infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.

NCT ID: NCT01735084 Completed - Cough Clinical Trials

Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life

PREV-IX_B
Start date: March 12, 2013
Phase: Phase 4
Study type: Interventional

HYPOTHESES: 1. That infants receiving PHiD-CV10 as a booster at 12 months of age, compared to controls having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels, lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of age. 2. That infants receiving PCV13 as a booster at 12 months of age, compared to controls having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes 3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation at 18 and 36 months of age.

NCT ID: NCT01734785 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This trial will compare the use of the FDC of empagliflozin and linagliptin to linagliptin alone as add-on to metformin in patients with T2DM.

NCT ID: NCT01733602 Completed - Schizophrenia Clinical Trials

tDCS to Enhance Cognitive Training in Schizophrenia

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

The primary aim for the study is to determine whether transcranial direct current stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to determine whether tDCS combined with CT causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects). Specific hypotheses are: 1. CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS. 2. CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS. 3. The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.

NCT ID: NCT01733576 Completed - Clinical trials for Verbal Learning and Memory

High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning

Start date: n/a
Phase: Phase 0
Study type: Interventional

This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.

NCT ID: NCT01732770 Completed - Clinical trials for Post Menopausal Osteoporosis

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Start date: November 7, 2012
Phase: Phase 4
Study type: Interventional

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

NCT ID: NCT01730807 Completed - Atrial Flutter Clinical Trials

IntellaTip MiFi XP Ablation Catheter Trial

MiFi-CTI
Start date: March 2013
Phase: N/A
Study type: Interventional

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.