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NCT ID: NCT01057537 Completed - Clinical trials for Cardiovascular Diseases

UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events

UMPIRE
Start date: June 2010
Phase: Phase 3
Study type: Interventional

People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity & cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.

NCT ID: NCT01057069 Active, not recruiting - Breast Cancer Clinical Trials

Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer

neo-TN
Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to compare the response of triple-negative breast cancer with deficient homologous recombination to intensified alkylating chemotherapy versus standard chemotherapy with dose dense AC and/or Docetaxel-Capecitabine.

NCT ID: NCT01056120 Completed - Clinical trials for De Novo and Re-stenosed Coronary Artery Lesions

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

ENERGY
Start date: March 2010
Phase: N/A
Study type: Observational

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

NCT ID: NCT01054573 Completed - Clinical trials for Hepatitis C, Chronic

VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

NCT ID: NCT01054417 Completed - Appendicitis Clinical Trials

APPEndicitis and Laparoscopic Criteria; APPEL Study

APPEL
Start date: December 2009
Phase: N/A
Study type: Observational

A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

NCT ID: NCT01054170 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

NCT ID: NCT01053611 Completed - Sedation During Clinical Trials

Composite Variability Index Versus Bispectral Index (BIS)

Start date: September 2009
Phase: N/A
Study type: Interventional

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

NCT ID: NCT01053377 Enrolling by invitation - Influenza Clinical Trials

A Randomised Controlled Trial on the Effect of Post-exposure Oseltamivir Prophylaxis on Influenza Transmission in Nursing Homes

PEPpIE
Start date: December 2009
Phase: Phase 4
Study type: Interventional

The incidence of severe morbidity and mortality following an influenza infection during the annual influenza epidemics is highest among the elderly population and 90% of influenzaassociated mortality occurs in this group. Vaccination is considered the best preventive intervention available but offers only partial protection. The protective effect decreases with advancing age and existing co-morbidity. Therefore, in spite of high compliance with vaccination, the risk of influenza-related complications among nursing-home residents, is particularly high, and consequently also the associated disease and economic burden. There is debate on the potential health benefit of the antiviral activity of oseltamivir as an effective supplementary intervention to prevent or contain influenza outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable vaccinated highrisk groups, such as the elderly population in nursing homes. If proven (cost)effective, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well.

NCT ID: NCT01052506 Completed - Healthy Clinical Trials

BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

NCT ID: NCT01051752 Completed - Clinical trials for Nontuberculous Mycobacterial Diseases

PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

NTM
Start date: January 2010
Phase: N/A
Study type: Observational

A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.