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NCT ID: NCT01964560 Completed - Epilepsy Clinical Trials

A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Start date: August 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

NCT ID: NCT01963286 Completed - Tachycardia Clinical Trials

Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

ReduceIT
Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.

NCT ID: NCT01960907 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials for Elderly Patients With Multiple Disease

CHROMED
Start date: October 2013
Phase: N/A
Study type: Interventional

The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.

NCT ID: NCT01950871 Terminated - Prostate Cancer Clinical Trials

Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

PHSTT-01
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis. The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01946568 Completed - Clinical trials for Bacterial Infections.

A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

Start date: June 2013
Phase: Phase 1
Study type: Interventional

A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

NCT ID: NCT01944839 Terminated - Clinical trials for Age-Related Macular Degeneration

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

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

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

NCT ID: NCT01940887 Terminated - Clinical trials for Age-Related Macular Degeneration

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

NCT ID: NCT01934725 Recruiting - Ischemic Stroke Clinical Trials

Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome

SECRETO
Start date: November 2013
Phase:
Study type: Observational

BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature death compared with background population. Up to 50% of young patients with ischemic stroke remain without definitive etiology for their disease despite extensive modern diagnostic work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover, there are only scarce data on clinical outcome, long-term risk of new vascular events, and prevention of such events in these patients. DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever ischemic stroke of undetermined etiology (aim N=2000). Patients are included after standardized diagnostic procedures (brain MRI, imaging of intracranial and extracranial vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be needed to recruit the planned participant population during a 3-year period. Neurovascular imaging and echocardiography studies, and ECGs will be read centrally. AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and clinical risk factors; (2) Long-term prognosis (new vascular events, functional and psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic study, including genome-wide association and candidate gene studies as well as next-generation sequencing approach. All analyses consider cardiac functional and interatrial structural properties as a possible mediator. Furthermore, SECRETO Family Study (substudy) aims at collecting extensive family history of thrombotic events from informative patients being screened for SECRETO main study and collect genetic samples from all consenting family members for whole-genome sequencing. SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young adults. This study also reveals long-term prognosis of this understudied patient population and may discover new genetic background underlying the disease mechanism and provide potential targets for drug development.

NCT ID: NCT01925768 Completed - Psoriatic Arthritis Clinical Trials

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Start date: September 4, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.