Patients will be given Salovum 1g/kg body weight/24 hours, divided into 6 dosages and given during 5 consecutive days.

Head Trauma

Intensive Care Neurological Disorder

Edema Brain

Salovum is freeze dried egg yolk, highly enriched with anti-secretory factor. Salovum is registered as a medical food by the EU

Salovum

Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury

Analysis of glucose, pyruvate and lactate from micro-dialysis fluid

Analysis of cytokines from micro-dialysis fluid

Peter Siesjö

Professor, Consultant

5 consecutive adult patients with severe head trauma will receive treatment

Patients in treatment group will receive Salovum according to g/kg body weight/24 hours/divided into 6 doses, during a maximum of 5 days

Patients in treatment group will receive Placebo (egg yolk powder) according to g/kg body weight/24 hours/divided into 6 doses, during a maximum of 5 days

Brain Trauma

Dietary supplement with high concentration of anti-secretory factor

Placebo

Department of Neurosurgery, Tygerberg Hospital, Francie Van Zijl Dr

Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury

Salovum (Antisecretory Factor) in Patients With Severe Traumatic Brain Injury

TIL is scored at the end of each 24 hour period in the NICU, where 0 is lowest intensity and 38 is maximum intensity

ICP in mm Hg is recorded every hour during 0-5 days

University of Stellenbosch

Randomized, double blinded and prospective.

Double blinded until the end of the trial. Unmasking will take place once all patients are included and the trial is concluded.

Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

Glioblastoma Multiforme

ketogenic diet

MidAtlantic Epilepsy and Sleep Center

Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study

Early treatment discontinuation, treatment compliance, 7-point Licker hunger scale, fasting lipid levels and fasting serum glucose and insulin levels

The secondary outcome measures will be (i) survival time and (ii) time to cerebral edema requiring steroid rescue treatment

the incidence of treatment-emergent AEs during treatment.

Mid-Atlantic Epilepsy and Sleep Center, LLC

University of Pittsburgh Medical Center

14 subjects with receive active treatment with Anakinra.

7 subjects will receive the placebo comparator.

Type I Diabetes

Anakinra treatment will be given I.V. as a bolus of 2 mg/kg infused intravenously over 30 minutes followed by infusion of 2 mg/kg/hour for 4 hours.

Anakinra

Placebo Comparator

Childrens Hospital Colorado

University of Colorado, Anschutz Medical Campus

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes.

Type and number of Adverse Events related to anti-IL-1 treatment (anakinra) during the initial 24 hour period of DKA treatment.

University of Colorado, Denver

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Gliadel/Avastin/CPT-11

Sex: Female, Male

The percentage of participants surviving 24 weeks from the start of study treatment

24-week Overall Survival

The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.

24-week Progression-free Survival (PFS)

Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.

Median Progression-free Survival (PFS)

Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Median Overall Survival (OS)

Incidence and Severity of Central Nervous System (CNS) Hemorrhage

Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities

Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities

Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.

Overall Study

Annick Desjardins, MD, FRCPC

Malignant Glioma

Gliosarcoma

Duke University Medical Center Clinical Trials

The Preston Robert Tisch Brain Tumor Center

brain edema/diarrhea

Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury

Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury

Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM)

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