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NCT ID: NCT02447081 Completed - Stroke Clinical Trials

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amulet™PMS
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

NCT ID: NCT02446912 Completed - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

NCT ID: NCT02446743 Completed - Clinical trials for Infections, Meningococcal

Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

Start date: November 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ

NCT ID: NCT02446717 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

NCT ID: NCT02446444 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

ENZARAD
Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.

NCT ID: NCT02446405 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

ENZAMET
Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

NCT ID: NCT02445443 Active, not recruiting - Clinical trials for Knee Arthroplasty, Total

LEGION Hinge Safety and Efficacy Study

LINKS
Start date: June 30, 2015
Phase:
Study type: Observational

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

NCT ID: NCT02445248 Completed - Clinical trials for Diffuse Large B-cell Lymphoma (DLBCL)

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

JULIET
Start date: July 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

NCT ID: NCT02445222 Recruiting - Clinical trials for Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

CAR-T Long Term Follow Up (LTFU) Study

PAVO
Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

NCT ID: NCT02444611 Completed - Clinical trials for Innate Immune Response

A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study

ELVIS
Start date: March 2015
Phase: N/A
Study type: Interventional

Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood disease-specific immunisation is irrefutably linked to the decline in deaths from these targeted infections over the last century. However, neonatal immunisation is limited, in part, by the impaired adaptive immune function in this age group. There is now an expanding body of evidence for heterologous ('non-specific') effects of various vaccines used in childhood. This refers to the immunomodulatory capabilities of vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The underlying immunological mechanisms responsible for these effects are incompletely understood, but evidence is mounting that the innate immune system is central to these observed effects. This study is a randomised controlled trial designed to determine the influence of two commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth, on the neonatal immune responses to non-specific antigens. The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne, Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups, receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1 week post randomisation) A blood sample will be taken at 1-week post randomisation for in vitro immunological analyses. This study will improve current understanding of the influence of vaccines on neonatal immunity and will help develop strategies exploiting beneficial heterologous ('non-specific') effects to improve protection against infection in the very young.