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NCT ID: NCT01213615 Completed - Clinical trials for Aortic Heart Valve Diseases

Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

Start date: August 2008
Phase: N/A
Study type: Observational

Since the first implant in September 1982, the Medtronic Hancock® II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6 anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A critical issue is the size of the prosthesis in relation to the patient's annulus. The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.

NCT ID: NCT01213472 Completed - Melanoma Clinical Trials

Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma

Start date: January 31, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma.

NCT ID: NCT01213212 Completed - Diabetes Mellitus Clinical Trials

Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk

CRESO
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The study investigates whether a caloric restricted dietary regime can prevent onset and/or progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity, through the amelioration of concomitant metabolic abnormalities such as insulin resistance, dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney disease. The main aim of the study is therefore to evaluate the renoprotective effect of caloric restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand how dietary implementation can modulate renal disease and its associated metabolic abnormalities.

NCT ID: NCT01212991 Completed - Prostate Cancer Clinical Trials

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

PREVAIL
Start date: September 16, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

NCT ID: NCT01212770 Completed - Psoriatic Arthritis Clinical Trials

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

PALACE 3
Start date: September 30, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

NCT ID: NCT01212757 Completed - Psoriatic Arthritis Clinical Trials

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

PALACE2
Start date: September 27, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

NCT ID: NCT01212146 Completed - Clinical trials for Functional Constipation

Probiotic-enriched Artichoke in Functional Constipation

PAFC
Start date: September 2010
Phase: N/A
Study type: Interventional

The aim of the present randomized double-blind controlled crossover study is to compare the effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients suffering from functional constipation.

NCT ID: NCT01211873 Completed - Clinical trials for Central Nervous System Diseases

Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

SENTIO
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

NCT ID: NCT01211483 Completed - Clinical trials for NSCLC (Advanced Non-small Cell Lung Cancer)

Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

NCT ID: NCT01210690 Completed - Epilepsy Clinical Trials

Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.