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NCT ID: NCT01584648 Completed - Melanoma Clinical Trials

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Start date: May 4, 2012
Phase: Phase 3
Study type: Interventional

This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

NCT ID: NCT01583374 Completed - Clinical trials for Ankylosing Spondyloarthritis

Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

POSTURE
Start date: May 2, 2012
Phase: Phase 3
Study type: Interventional

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

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: NCT01583153 Completed - Osteoarthritis Clinical Trials

The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement

HIHO
Start date: June 2012
Phase: N/A
Study type: Interventional

Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode. The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home. The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken. Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility. Superiority in these outcomes will be evident at six months after surgery.

NCT ID: NCT01582763 Active, not recruiting - Clinical trials for Guillain-Barré Syndrome

International Guillain-Barré Syndrome Outcome Study

IGOS
Start date: May 1, 2012
Phase:
Study type: Observational

International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS). The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

NCT ID: NCT01582269 Active, not recruiting - Glioblastoma Clinical Trials

A Study in Recurrent Glioblastoma (GB)

Start date: April 26, 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

NCT ID: NCT01581827 Completed - Heart Failure Clinical Trials

SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

SHF-L
Start date: January 2009
Phase:
Study type: Observational

Heart failure (when the heart does not pump as well as it used to) is a medical condition which reduces the quality of life for the sufferers. Approximately 10% of people in western societies aged over 75 develop heart failure. There has been a shift towards prevention of this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal proBNP) will prove to be useful indicators of those at greatest risk. The current study therefore plans to follow up the 3500 participants at risk of heart failure from the original SCREEN-HF study. Participants who are willing to participate will be contacted annually. They will undergo a short physical exam, will be asked to complete a Quality of Life questionnaire and will have a blood sample taken. At the end of the study participants will also have an ECG and an echocardiogram.

NCT ID: NCT01581476 Completed - Type 1 Diabetes Clinical Trials

Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

AdDIT
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

NCT ID: NCT01581203 Completed - Hepatitis C Virus Clinical Trials

Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

Hallmark DUAL
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

NCT ID: NCT01580566 Completed - Clinical trials for Myocardial Infarction

Renal Acute MI Study

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to determine if a sizable myocardial infarction (heart attack) results in negative changes to renal structure and function (i.e. has a negative impact on the kidneys). To determine if the renal response to a myocardial infarction is a predictor of the patients future health.