The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.

Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.

The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.
Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements

Treatment With Recombinant Human Growth Hormone

Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.
Placebo: SC injection daily

Placebo Treatment

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Baseline IGF-1 level < 1 SD below expected mean

Baseline L-Arginine stimulation test

Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function.
100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal

rhGH Treatment

Placebo Treament

Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index

Serum levels of Insulin-Like Growth Factor-1.

Active Treatment With Recombinant Human Growth Hormone

IGF-1 Levels.

Processing Speed Index 1 Year After Injury

Measurement of serum GH levels over 90 minutes after administration of L-arginine

GH Response to L-arginine Stimulation at Baseline

Serum IGF-1 levels at baseline for both treatment groups was correlated with the Processing Speed Index recorded at baseline, using Pearson's correlation coefficient. Perason's correlation coefficient is a measure of the linear correlation between two variables X and Y. It has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.

IGF-1 Levels

Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.

Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.

Overall Study

Ramon Diaz-Arrastia

Recombinant Human Growth Hormone

Traumatic Brain Injury

400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements

Recombinant human Growth Hormone

Placebo

Center for NeuroSkills

Baylor University Medical Center

University of Texas Southwestern Medical Center

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

A Phase II, Randomized Controlled Trial of Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

Professor of Neurology

University of Pennsylvania

Baylor Health Care System

Macular Degeneration

Retinal Vein Occlusion

Triamcinolone Acetonide (TAC-PF)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders

Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders

National Eye Institute (NEI)

benzyl alcohol

éidéime

edema

benzyl alcohol/éidéime

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders

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