subcutaneous Granulocyte - Colony Stimulating Factor ( on top of optimal standard of care) and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Patients will be receive optimal standard of care and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Anterior Myocardial Infarction

Heart Failure

rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously

rhu G-CSF

optimal standard of care

Myocardial Contrast Echocardiography with sulphur hexafluoride.

Myocardial Contrast Echocardiography

Fondazione Policlinico Universitario Agostino Gemelli

RIGENERA 2.0 Trial

RIGENERA 2.0 (Recupero Dall'Infarto Miocardico Con G-CSF E Nuovi Esempi di Rigenerazione Avanzata) Project: "The Combined Effect of Subcutaneous Granulocyte - Colony Stimulating Factor and Myocardial Contrast Echocardiography With Intravenous Infusion of Sulphur Hexafluoride on Post-infarction Left Ventricular Function"

Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic Resonance and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Clinical Major adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and rehospitalization due to heart failure) at 1 year

Antonio Maria Leone, MD

MD, PhD

Catholic University of the Sacred Heart

We randomly allocated patients to treatment with IVIG or placebo. Children received either saline or intravenous immunoglobulin (IVIG) [ImmunoRel™ (batch 20081217)] at a dose of 400mg/kg/day for 5 days or an equivalent volume of 0.9% normal saline given intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute. All investigators, care providers and participants were blinded of the study drug. A second sealed envelope was kept with the patient's notes in case a physician urgently needed to know which drug a patient had received.

Japanese Encephalitis

IVIG group received 400mg/kg/day intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute for 5 days or appearance of side effect or adverse events.
Placebo group received 0.9% saline intravenous at similar rate.

Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]

Kanti Children's Hospital

BP Koirala Institute of Health Sciences

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

A Randomized Double Blind Placebo Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin (IVIG) in Children With Japanese Encephalitis in Nepal

Patients will be monitored for side effects such as infusion site reaction, diarrhea, rise in blood pressure (in mm Hg) and change in urinary output (in ml/Kg/hour) every 12 hours from first day of commencing treatment until until death or discharge. Patient on average are administered the study drug on the first day of admission. The study drug is administered daily for 5 days. Patients are discharged on an average on eighth day (192 hours) of hospital admission.

At the time of discharge(expected average of eighth day of admission) or death: Time to death, to recover from coma, to sit independently, to stand independently, to walk at least 5m independently, and to leave hospital.
At 6 months after discharge: history of further seizures, behavioral changes, evidence of recovery of neurological sequelae such as assessment of ability to sit independently, to stand independently, to walk at least 5 meters independently.

Pre-treatment was immediately prior to the first dose of study drug on the first day, mid-treatment was immediately prior to the 4th dose and post-treatment was 1hour after administering the fifth dose of the study drug.

Ajit Rayamajhi

Clinical Research Fellow (PhD Student)

University of Liverpool

B.P. Koirala Institute of Health Sciences

Receives Lactated Ringers solution at 3cc/kg/hr following an initial 20cc/kg bolus.

Receives Lactated Ringers solution at 1.5cc/kg/hr following an initial 10cc/kg bolus.

Pancreatitis

Receives 20cc/kg bolus and 3cc/kg/hr thereafter.

Aggressive Hydration

Receives 10cc/kg bolus and 1.5cc/kg/hr thereafter.

Moderate Hydration

Los Angeles County Hospital

Moderate Versus Aggressive Fluids for Acute Pancreatitis

Moderate Versus Aggressive Fluid Therapy in Patient With Mild to Moderate Acute Pancratitis

Decreased hematocrit, BUN, Cr compared to time zero, decreased epigastric pain, and ability to tolerate PO's.

Time required to reach clinical improvement (as defined in primary outcome measure)

Patients initally in the moderate hydration arm who have an increase in BUN, CR, Hematocrit, or epigastric pain and thus are crossed over to the aggressive hydration arm.

SIRS will be defined based on having 2 out of 4 possible criterion. A) heart rate >90, respiratory rate >20, Temperature greater than 100.4 degrees farenheit or less than 96.8 degrees farenheit. White blood count >10 of <4.

Severe pancreatitis will be defined if 1 of the following is present; pancreatic necrosis (>30%) or abscess, blood pressure <90mmHg, oxygen saturation <90%, Cr >2mg/dl after 12 hours of resuscitation, >10 days hospitalization, or pseudocyst. Pseudocyst is deefined as a peripancreatic fluid collection which does not resorb within 4-8 weeks.

Physical exam findings of pitting edema, ascites, anasacra, pulmonary edema, or dyspnea.

oliguria/nekroza

RIGENERA 2.0 Trial

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

Moderate Versus Aggressive Fluids for Acute Pancreatitis

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