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Clinical Trials: Women’s Health (Infertility, Menopause, Etc.)
IRB No. 11-057-6 (Dr. Cheryl Oncken, PI): Nicotine Replacement for Smoking Cessation during Pregnancy
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler). The primary goals are: to examine the efficacy of the nicotine inhaler compared to a matched placebo for smoking cessation and reduction among pregnant smokers; to compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine) and on birth outcomes (i.e., birth weight and gestational age); to identify factors that determine which women benefit most from the use of nicotine inhaler for smoking cessation during pregnancy; to explore mechanisms by which the nicotine inhaler increases birth weight and gestational age
IRB No. 11-029-3 (Dr. Molly Brewer, PI): A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/ Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma (GOG0249)
The purpose of this study is to compare the effects of radiation therapy to the pelvis (SoC) with vaginal radiation therapy followed by 3 cycles of the chemotherapy drugs, paclitaxel and carboplatin in patients with high s-risk Stage I-II endometrial cancer. Additionally, this study will compare treatment groups by looking at survival, side effects and differences in location of cancer reoccurrence in patients. By evaluating blood and tumor specimens, this research study aims to determine trends that may help identify which patients may respond best to which treatments.
IRB No. 14-197-6 (Dr. Damion Grasso, PI): The Influence of Prenatal Exposure to Stress on the DNA Methylation Status of FKBP5 in Newborns
Understanding the impact of prenatal maternal stress (PNMS) on child development is needed to identify at-risk children at the earliest possible time point and to design and implement effective interventions. One of the genes involved in the stress response pathway is FKBP5 (FK506 binding protein 5). The FKBP5 protein is a critical component of a negative feedback loop that functions to terminate the stress response at the cellular level by decreasing ligand binding and blocking translocation of the glucocorticoid receptor complex into the nucleus. Emerging data on FKBP5 suggests one potential pathway by which early, chronic childhood trauma exposure may lead to emotional and behavioral problems later in life. This study seeks to understand how the in utero exposure to domestic violence can impact ability of this gene to function properly.