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NCT ID: NCT02338154 Completed - Aortic Stenosis Clinical Trials

EDWARDS INTUITY Valve System FOUNDATION Study

FOUNDATION
Start date: July 2012
Phase:
Study type: Observational

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

NCT ID: NCT02337907 Completed - Alzheimer Disease Clinical Trials

BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: January 21, 2015
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

NCT ID: NCT02336451 Completed - Clinical trials for ALK-positive Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Ascend-7
Start date: April 1, 2015
Phase: Phase 2
Study type: Interventional

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

NCT ID: NCT02335502 Completed - Chronic Pain Clinical Trials

A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

Start date: April 2012
Phase:
Study type: Observational

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.

NCT ID: NCT02334371 Completed - Ovarian Neoplasms Clinical Trials

MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

Start date: April 2015
Phase: N/A
Study type: Interventional

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer.

NCT ID: NCT02333643 Completed - Cutaneous Warts Clinical Trials

A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

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

A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.

NCT ID: NCT02333175 Completed - Parkinson's Disease Clinical Trials

Care for Late Stage Parkinsonism

CLaSP
Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

NCT ID: NCT02329808 Completed - Kidney Diseases Clinical Trials

Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics

PROTECT
Start date: June 2015
Phase:
Study type: Observational

This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population. The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.

NCT ID: NCT02329327 Completed - Bleeding Clinical Trials

A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

Start date: April 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

NCT ID: NCT02328820 Completed - Clinical trials for Coronary Artery Disease

Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses

DEFINE-FLOW
Start date: October 2014
Phase: N/A
Study type: Interventional

This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).