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NCT ID: NCT01658241 Completed - Multiple Myeloma Clinical Trials

Panobinostat Biological Correlates Study

VEG VCA1
Start date: July 16, 2012
Phase: Phase 2
Study type: Interventional

This study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells). Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all patients benefit from panobinostat. The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this project is find out which patients or diseases are likely to respond to treatment with panobinostat in the future and to see if there are particular features of the patient or of the cancer that affects the likelihood of the way individuals respond to panobinostat. Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in normal cells make proteins. Panobinostat has been used in several clinical trials around the world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients have significant improvement in their disease. Researchers will look at samples of tumour before treatment and during treatment. This will be one of the first studies to look at how cancer cells change following treatment with this drug. It is unusual because it requires repeated biopsies of the participant's tumour. Panobinostat is considered an experimental (or investigational) drug and not approved by any regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer. Therefore, Panobinostat is not approved to treat patients who have been diagnosed with refractory or relapsed cancer. A total of 30 patients with one of the diseases listed above will be enrolled at Peter MacCallum Cancer Centre. It is expected it will take about 2 to 3 years to recruit 30 patients and that on average patients will take part for six to eighteen months. This time could be shorter or longer depending on how well the treatment works in each individual. While the trial will take up to 4 years to complete, the science studies may take longer.

NCT ID: NCT01657526 Completed - Clinical trials for Respiratory Disorders

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

Start date: August 8, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.

NCT ID: NCT01657110 Completed - Acne Clinical Trials

Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne

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

Mild to moderate facial acne is an extremely common disease of teenagers and young adults. This pilot study will investigate whether treatment with a gel containing tea tree oil reduces numbers of acne lesions and improves acne in twenty otherwise healthy consenting participants. The hypothesis is that treatment with tea tree oil gel will result in a significant improvement in acne after 12 weeks of treatment.

NCT ID: NCT01656941 Completed - Clinical trials for Congenital Heart Disease

Genetic Determinants of Congenital Heart Disease Outcomes

GECHO
Start date: March 2011
Phase:
Study type: Observational

The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. The goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.

NCT ID: NCT01653912 Completed - Clinical trials for Recurrent Platinum-resistant Ovarian Cancer

Dose-finding Study in Platinum-Resistant Ovarian Cancer

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

- Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer. - Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

NCT ID: NCT01653431 Completed - Clinical trials for Mild Cognitive Impairment

Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.

NCT ID: NCT01652482 Completed - Colorectal Cancer Clinical Trials

Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

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

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01650896 Recruiting - Delirium Clinical Trials

Prospective Randomised Controlled Trial of Delirium Management by Geriatric Medicine Versus General Medicine

CADIS
Start date: July 2012
Phase: N/A
Study type: Interventional

The typical delirium study between 1989 and 2005 compared delirium management in a specialty unit such as geriatric medicine with delirium management in general medicine (in most cases the research diagnosis of delirium was not communicated to the general medicine group). This study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and general medicine groups (medical staff, patients, families) plus daily monitoring of delirium using digit span and delirium index which is reported to both patient groups. It will also compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored daily (even in speciality units it is rare to find daily measurement of tools such as delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting hard endpoints (survival and return home rate for patients living in the community).

NCT ID: NCT01650805 Terminated - Clinical trials for Chronic Myeloid Leukemia

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

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

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

NCT ID: NCT01650701 Active, not recruiting - Follicular Lymphoma Clinical Trials

A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

RELEVANCE
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.