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NCT ID: NCT02306460 Terminated - Atrial Fibrillation Clinical Trials

Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation

Start date: February 9, 2015
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation. However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation. The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.

NCT ID: NCT02281721 Terminated - Cerebral Aneurysm Clinical Trials

Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Start date: March 18, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

NCT ID: NCT02265380 Terminated - Clinical trials for Peripheral Venous Catheterization

A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

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

A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

NCT ID: NCT02263508 Terminated - Melanoma Clinical Trials

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

MASTERKEY-265
Start date: December 8, 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and overall survival (OS).

NCT ID: NCT02258464 Terminated - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: March 2, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

NCT ID: NCT02245568 Terminated - Alzheimer's Disease Clinical Trials

Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

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

The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.

NCT ID: NCT02235753 Terminated - Clinical trials for Acute Myocardial Infarction

High-intensity Exercise After Acute Cardiac Event (HITCARE)

HITCARE
Start date: December 2014
Phase: N/A
Study type: Interventional

Despite the well-known health benefits of physical exercise in the prevention of chronic diseases, less attention has been focused on the use of physical exercise as an essential part of good treatment for chronic disease. The aims of the study are to investigate the feasibility, medical effects, cost-effectiveness, and social perspectives of the individualized exercise-based rehabilitation [2 different high-intensity training (HIT) protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The medical aim is to study mediating mechanisms of the physiological, biochemical and molecular effects of exercise training on the clinical outcomes. The aim of the health-economic evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health care related costs for estimating the cost-effectiveness of HIT-based exercise rehabilitation. The purpose of the sociological analysis is to find out the social processes which make possible the emergence of the desired welfare effects.

NCT ID: NCT02224235 Terminated - Stable Angina Clinical Trials

COBRA SHIELD OCT Study

Start date: June 2014
Phase: N/A
Study type: Interventional

Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual anti-platelet therapy (DAPT) for at least 6 months followed by aspirin. After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3). Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month follow up.

NCT ID: NCT02216149 Terminated - Colon Cancer Clinical Trials

Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

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

Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow response to a cold pressor test, in a patient population who are being treated for adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens, either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.

NCT ID: NCT02193867 Terminated - Clinical trials for Lysosomal Acid Lipase Deficiency

Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency

Start date: June 6, 2014
Phase: Phase 2
Study type: Interventional

This was an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly progressive lysosomal acid lipase deficiency (LAL-D). Eligible participants received once-weekly infusions of sebelipase alfa for up to 3 years.