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NCT ID: NCT01786512 Completed - Pharmacokinetics Clinical Trials

COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

COSMIC-HF
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

NCT ID: NCT01785888 Completed - Clinical trials for EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.

Europe-Japan Diagnostic Study for EGFR Testing

ASSESS
Start date: April 2013
Phase: N/A
Study type: Observational

This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

NCT ID: NCT01785875 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

NCT ID: NCT01785849 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

NCT ID: NCT01785745 Completed - Clinical trials for Shoulder Impingement Syndrome

Study of Neurocognitive Therapeutic Exercise in the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise

Start date: July 2012
Phase: N/A
Study type: Interventional

It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of treatment.

NCT ID: NCT01785121 Completed - Heart Failure Clinical Trials

Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

HF-Wii
Start date: September 2013
Phase: N/A
Study type: Interventional

The study objectives are to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. Secondly, to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life. The following research questions will be addressed: - What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure to improve their exercise capacity compared to patients with heart failure in a control group who only receive motivational support? - What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure compared to patients with heart failure in a control group who only receive motivational support to increase their daily physical activity, decrease health care use and improve quality of life? - What are experiences of heart failure patients and how is their exercise motivation when they are introduced and instructed to play with a Wii game computer?

NCT ID: NCT01784835 Completed - Prematurity Clinical Trials

Early Exposure to OMT Prevents Long LOS

Start date: October 2010
Phase: N/A
Study type: Interventional

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

NCT ID: NCT01784055 Completed - Clinical trials for Cardiovascular Diseases

NeoChord TACT Post-Market Surveillance Registry

Start date: March 2013
Phase:
Study type: Observational [Patient Registry]

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

NCT ID: NCT01783678 Completed - Chronic Hepatitis C Clinical Trials

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

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

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

NCT ID: NCT01783639 Completed - Stroke Clinical Trials

Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

WISE
Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies