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NCT ID: NCT01231165 Completed - Clinical trials for Coronary Heart Disease

Treatment of Coronary Heart Disease With Amiloride

Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases. A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions. This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content. The purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic changes of myocardial ischemia and electrical regeneration of the heart in subjects with coronary artery diseases.

NCT ID: NCT01228214 Active, not recruiting - Clinical trials for Coronary Artery Disease

Novel Treatment for Coronary Artery Disease

Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases. A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions. This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content, as in hypertensives or CAD patients.

NCT ID: NCT01207648 Completed - Multiple Sclerosis Clinical Trials

Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)

REPLAY
Start date: July 2010
Phase: N/A
Study type: Observational

The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records. The study duration is 13 July 2010 (first data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects evaluated between 1997 and 2009 was observed.

NCT ID: NCT01203111 Completed - Clinical trials for Diabetes Mellitus, Type 2

Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

CHANGING
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives: 1. Percentage of patients with HbA1c < 7% at week 24. 2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24. 3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24. 4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24. 5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24. 6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

NCT ID: NCT01200160 Completed - Clinical trials for Cardiovascular Diseases

Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America

Start date: February 2010
Phase: N/A
Study type: Observational

Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of observation of 12 months. This includes an enrollment period of 6 months in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on Case Report Forms (CRFs) by the investigator or site staffs according to the protocol.

NCT ID: NCT01171404 Completed - Clinical trials for Coronary Artery Disease

Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge

EPICOR
Start date: September 2010
Phase: N/A
Study type: Observational

The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

NCT ID: NCT01164852 Completed - Preeclampsia Clinical Trials

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

MEXPRE-Latin
Start date: August 2010
Phase: N/A
Study type: Interventional

How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

NCT ID: NCT01126892 Completed - Clinical trials for Chronic Myeloid Leukemia

A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

ENACT
Start date: January 2009
Phase: Phase 3
Study type: Interventional

A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.

NCT ID: NCT01110967 Completed - Clinical trials for Degenerative Disc Disease, Lumbar

Satellite™ PEEK Nucleus Replacement Retrospective Analysis

Start date: April 2010
Phase: N/A
Study type: Observational

The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting. The purpose of this study is to evaluate number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion. All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.

NCT ID: NCT01093482 Completed - Clinical trials for Acute Respiratory Failure

Third International Study on Mechanical Ventilation

ISMV
Start date: April 2010
Phase: N/A
Study type: Observational

The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units: 1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients 2. Secondary analyses: - To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation. - To compare the results with prior data collected in previous observational studies (1998 and 2004) - Non-invasive positive pressure ventilation - Weaning - Use of adjuvant therapies as steroids or selective digestive decontamination - Sedation including prevalence of delirium in mechanically ventilated patients - Prediction of the duration of mechanical ventilation - Other