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Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

2014-08-27 03:12:56 | BioPortfolio

Summary

The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Brain Injuries

Intervention

Progesterone, Lipid emulsion without progesterone

Location

University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
United States
15213

Status

Recruiting

Source

BHR Pharma, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:56-0400

Clinical Trials [1665 Associated Clinical Trials listed on BioPortfolio]

Progesterone Treatment of Blunt Traumatic Brain Injury

The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.

Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone

The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on...

Digestion of Biopolymer Based Lipid Emulsions

In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that th...

Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

Until now very little information exists regarding the early luteal serum progesterone profile after Human chorionic gonadotropin (hCG) trigger. This pilot-study will help characterize the...

Variation of Progesterone in IVF Cycles

to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be ...

PubMed Articles [11107 Associated PubMed Articles listed on BioPortfolio]

Intranasal administration of progesterone: A potential efficient route of delivery for cerebroprotection after acute brain injuries.

Progesterone has been shown to be cerebroprotective in different experimental models of brain injuries and neurodegenerative diseases. The preclinical data provided great hope for its use in humans. T...

Repurposing and repositioning neurosteroids in the treatment of traumatic brain injury: A report from the trenches.

The field of neuroprotection after brain injuries has been littered with failed clinical trials. Finding a safe and effective treatment for acute traumatic brain injury remains a serious unmet medical...

Sleep after intranasal progesterone vs. zolpidem and placebo in postmenopausal women - A randomized, double-blind cross over study.

The loss of progesterone during menopause is linked to sleep complaints of the affected women. Previously we demonstrated sleep promoting effects of oral progesterone replacement in postmenopausal wom...

Vaginal progesterone and the vaginal first-pass effect.

Vaginal progesterone is an effective alternative to systemic administration by oral or intramuscular use. The first-pass effect is reviewed, as are the most common uses for this route of delivery. Thi...

Progesterone and plasma metabolites in women with and in those without premenstrual dysphoric disorder.

The molecular mechanisms underpinning the progesterone-triggering mood symptoms in women with premenstrual dysphoric disorder (PMDD) are unknown. Cell metabolism is a potential source of variability. ...

Medical and Biotech [MESH] Definitions

Specific proteins found in or on cells of progesterone target tissues that specifically combine with progesterone. The cytosol progesterone-receptor complex then associates with the nucleic acids to initiate protein synthesis. There are two kinds of progesterone receptors, A and B. Both are induced by estrogen and have short half-lives.

Steroidal compounds related to PROGESTERONE, the major mammalian progestational hormone. Progesterone congeners include important progesterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with progestational activities.

The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.

A glycoprotein migrating as alpha 1-globulin, molecular weight 70,000 to 120,000. The protein, which is present in increased amounts in the plasma during pregnancy, binds mainly progesterone, with other steroids including testosterone competing weakly.

A biologically active 20-alpha-reduced metabolite of PROGESTERONE. It is converted from progesterone to 20-alpha-hydroxypregn-4-en-3-one by the 20-ALPHA-HYDROXYSTEROID DEHYDROGENASE in the CORPUS LUTEUM and the PLACENTA.

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