Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days

Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days

Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days

Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days

D0.01

D0.03

D0.06

D0.20

Total

Sex: Female, Male

Race/Ethnicity, Customized

Age, at diagnosis

Disease onset

Disease triggers

Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)

Intent-to-treat

Total Daily Symptom Score (TDSS)

Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)

SF-36, PCS

Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)

SF-36, MCS

Patient enrolled, but screened-out before receiving treatment

Screen Failures

Pre-treatment Assessment

Treatment

Post-treatment Assessment

Lucinda Bateman, MD

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

CT38

Bateman Horne Center

Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

Pilot Phase 1/2, Open-Label, Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

LUCINDA BATEMAN, MD

Founder & Medical Director

The study is comprised of a recruitment and screening period, enrollment (Visit 1), a 4-week (at least) pre-treatment assessment period, a 1-week interventional treatment period with drug infused at Visits 3, 4 and 4b, a 4-week (at least) post-treatment assessment period, and a close-out (Visit 6).

Acute Disseminated Encephalomyelitis

clinical audit on management of acute disseminating encephalomyelitis

management of acute disseminating encephalomyelitis

Management Of Acute Disseminating Encephalomyelitis

Management of Acute Disseminated Encephalomyelitis in Neurology Unit of Assiut University Children Hospital

To improve diagnosis and management of acute disseminated encephalomyelitis in Neurology Unit of Assiut University Children Hospital and to decrease the mortality and residual deficits from this disease.
The aim of this audit is to measure the current practice within the Neurology Unit of Assiut University Children Hospital team in the diagnosis and management of acute disseminated encephalomyelitis against the recommendations in American Academy of Neurology guidance by using checklist and designed questionnaire.

Marwa Alsaid Ahmed

Principle Investigator

Assiut University

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.

encephalomyelitis/illamående

Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

Management Of Acute Disseminating Encephalomyelitis

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

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