INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).

Glioblastoma Multiforme

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

DIPG

High-grade Astrocytoma NOS

CNS Primary Tumor, NOS (Malignant Glioma)

INCB7839

Children's Hospital Los Angeles

Lucile Packard Children Hospital Stanford University

Children's Hospital Colorado

Children's National Medical Center

Children's Healthcare of Atlanta

Lurie Childrens Hospital-Chicago

National Cancer Institute Pediatric Oncology Branch

Dana Farber Cancer Institute

Memorial Sloan Kettering Cancer Center

Cincinnati Children Hospital Medical Center

Children Hospital of Pittsburgh of UPMC

St. Jude Children Research Hospital

Baylor College of Medicine

INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

A Phase I Study of the Adam-10 Inhibitor, INCB7839 in Children With Recurrent/Progressive High-Grade Gliomas to Target Microenvironmental Neuroligin-3

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.

To estimate the maximum tolerated dose (MTD) and/or recommend Phase II dose (RP2D) of INCB7839 administered orally in children with recurrent/progressive high-grade glioma.

The area under the curve (AUC) will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The maximum concentration [CMAX] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The apparent oral clearance [CL/F] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The time to reach CMAX [TMAX] will be calculated based on the course 1 days 1 and 2 pharmacokinetic samples.

The progression-free survival will be reported.

The duration of response will be reported.

HER2 extracellular domain in serum will be reported.

Neuroligin-3 (NLGN3) in cerebral spinal fluid will be reported.

The maximum concentration [CMAX] will be calculated based on the CSF pharmacokinetic samples.

Pediatric Brain Tumor Consortium

This is a phase I study and we will use a design similar to the Rolling-6 design and open 6 slots initially on Dose level 1. If we observe no-more than 1 DLT in these 6 subjects then we would expand this cohort to at least 12 patients for PK and additional safety information. If more than 1 DLT is observed on dose level 1 in 2-6 subjects, then further enrollment to dose level 1 will stop, the dose will be de-escalated to dose level 0 and the same approach will be repeated. Based on the above-outlined de-escalation rules, if dose level 0 is found to be too toxic, then the trial will be closed to accrual and the merits of amending or closing the trial permanently will be reconsidered.

they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.

Breast Fibroadenoma

Patients were lying prone. Firstly, T2, 3, 4 disc level was detected then the target 2nd, 3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by 2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve roots.The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of 1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.

pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.

Tamoxifen

Yahay wahba

Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).

nausea, vomiting, hot flashes and dizziness.

Nevert Adel

lecturer of anesthesia

Mansoura University

After premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group P Patients received IV Propofol 2mg kg-1 slowly over 60 seconds till Entropy of 40 as a comparator agent in patients undergoing Medical termination of pregnancy(MTP) and Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP

After premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP and placebo group received normal saline

Hemodynamics

Side Effects

Induction of anesthesia using IV Etomidate 0.3mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0`.2mg kg-1 and IV Fentanyl 2ug kg-1.

Inj Etomidate

Induction of anesthesia using IV Propofol 2mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0.2mg kg-1 and IV Fentanyl 2ug kg-1

Injection Propofol

After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given.

Placebo for Propofol

Etomidate vs Propofol-Induction Characteristics

Comparison of Induction Characteristics of Two Anaesthetic Agents-Etomidate Lipuro and Propofol

Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia (Heart rate <50 was noted .

Mean value of Mean Arterial Pressures(Summation of MAP divided by number of patients) at above mentioned time intervals was noted and study drug causing Hypotension(MAP< 90mm of Hg) was noted.

0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. Pain on injection was measured using scale as 0 no pain,1verbal complaint to pain,2 withdrawal of arm,3 both verbal complaint and withdrawal of arm

Using Myoclonus scale as 0.No myoclonic movement. I. Minor myoclonic movement. II. Moderate myoclonic movement. III. Major myoclonic

Presence or absence of inflammation of vein through which the drug was injected.

Shakuntala Basantwani

Associate Professor

Maharashtra University of Health Sciences

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.

thrombophlebitis/mual

INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

Etomidate vs Propofol-Induction Characteristics

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

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