Search Results within category "Women's Health"
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The Sexual Relationships Study
The purpose of this study is to examine the sexual relationships among heterosexual female college students (ages 18-22) via Qualtrics (a web-based survey). Utilizing latent class analysis with a distal outcome, the proposed cross-sectional study seeks to do the following:
Aim 1. Examine the heterogeneity in relationship quality among female college students.
Research question 1: Is there a latent class structure that adequately represents the heterogeneity in relationship quality among female undergraduate students participating in penile-vaginal sex? If so, what are the types and their corresponding prevalence?
Aim 2. Examine the association between relationship characteristics and latent class membership.
Research question 2: Are relationship characteristics (partner type, relationship duration, exclusivity/monogamy, and frequency of sex) predictive of membership in latent classes of relationship quality?
Aim 3. Examine the association between latent classes of relationship quality and condom use.
Research question 3: Which identified latent class of relationship quality is significantly associated with condom use at last penile-vaginal sex?
Please note that the indicators measuring relationship quality will include the following variables: 1) trust, 2) love, 3) passion, 4) commitment, 5) relationship satisfaction, 6) sexual satisfaction, 7) intimacy, and 8) decision-making dominance.
Jessica Salas-Brooks at jis5940@psu.edu or 704-249-4252
Female
18 year(s) or older
N/A
Women's Health
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
This study is for patients who have been diagnosed with moderate to severe ulcerative colitis (UC) who are experiencing bloody diarrhea, abdominal pain, and a sudden and constant feeling of needing to move their bowels. Additionally, patients have been unable to tolerate or have had an insufficient response to treatment with medications that help reduce inflammation associated with UC. This research is being done to evaluate the safety of different doses of ABT-494 (study medication) and determine how well it works, as well as how the study medication is absorbed, distributed and eliminated in the body over time.
Amy Behe at abehe@pennstatehealth.psu.edu or 814-689-0014
All
18 year(s) or older
NCT02819635
Men's Health, Digestive Systems & Liver Disease, Women's Health
Role of microRNA activation of lectin-like oxidized LDL receptor (LOX-1) mechanisms in microvascular dysfunction in women with endometriosis
Endometriosis is a gynecological disorder associated with chronic pelvic pain, pain during intercourse, and infertility. With endometriosis, endometrium-like tissue is found in sites outside the uterine cavity. This disorder affects 6% - 10% of women of reproductive age. It can be as high as 35-50% in women who have pain or infertility. Endometriosis is associated with higher risk of hypercholesterolemia and hypertension that increases risk for cardiovascular disease (CVD). CVD is characterized by dysfunction of the blood vessels of the body. CVD is the leading cause of death in women.
Two groups of women complete this study: 1) healthy women between the ages of 18 and 45 years (Controls); 2) women between the ages of 18 and 45 years with endometriosis. The screening and two experiments include blood draws. After passing a medical screening, each subject participates in a microdialysis (MD) experiment before and after 6-9 days of oral atorvastatin therapy (10mg/day). Atorvastatin (brand name: Lipitor) is an FDA-approved drug that physicians prescribe to lower blood cholesterol. The atorvastatin also suppresses substances made by the body that increase the risk of CVD. MD is a procedure in which a thin tube of membrane that mimics a capillary blood vessel is implanted in the skin. Substances of interest are added to the saline flowing through the MD sites and are delivered into small areas of skin. The MD experiments combine the perfusion of the test-substances with local heating of the skin to explore the causes for the dysfunction of blood vessels and increased risk for CVD that occurs with endometriosis.
Susan Slimak at sks31@psu.edu or 814-863-8556
Female
18 year(s) or older
N/A
Heart & Vascular, Pregnancy & Infertility, Women's Health
Site For COMET-PCOS
Site For COMET-PCOS
Patsy Rawa at prawa@pennstatehealth.psu.edu or 717-531-3692
Female
18 year(s) or older
NCT03229057
Women's Health
Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia
This research is conducted to test if virtual reality technology is effective to help people face their social fears and promote the use of adaptive social skills in various settings. You will be immersed in a range of virtual reality environments and work with a research therapist to learn certain skills, such as managing fears of negative evaluation during job interviews, and interacting with peers in common social settings (e.g., classrooms, cafeterias).
Hani Zainal at nvz5057@psu.edu or 814-863-0115
All
18 year(s) or older
N/A
Men's Health, Mental & Behavioral Health, Women's Health
Understanding the Relationship between Education and Well-being among College Students with Disabilities
The purpose of the study is to gain an understanding of students’ experiences in college and their engagement help-seeking and healthy behaviors. Participation in the study involves completing a brief online-survey on Qualtrics, which we anticipate will take approximately 20 minutes to complete.
Amber O'Shea at amo5208@psu.edu or 814-867-5721
All
18 year(s) or older
N/A
Education, Mental & Behavioral Health, Women's Health
Coparenting, Infant Sleep, and Infant Development: An Intervention Study
This application proposes a randomized clinical trial (RCT) to evaluate the effects of a sleep-enhanced adaptation of an evidence-based transition-to-parenting coparenting intervention program [Family Foundations - FF). The study has three arms. In one arm, families will experience FF as originally formulated; in the second, families will receive an adapted FF that emphasizes coparenting in infant sleep contexts; the third arm will serve as controls. Assessments of coparenting and parenting in infant sleep contexts, parental adjustment to infant sleep behavior, choices about sleep arrangements, infant and parent sleep quality, and infant socio-emotional functioning, will serve as outcomes.
Morgan Loeffler at FF@psu.edu or 717-695-7050
All
18 year(s) or older
NCT03187561
Pregnancy & Infertility, Sleep Management, Women's Health
The Daily Reflections Study
This 14-day daily diary study is being conducted to better understand how young adults' thoughts and feelings about their bodies influence their health behaviors, and how their daily experiences and characteristics contribute to their health behaviors. Participants will be asked to complete a 10-20 minute baseline survey and a brief (5-8 minutes) daily survey each day for 14 consecutive days. Surveys will include questions about participants' mental and physical health, emotions, relationships, health behaviors, thoughts, and experiences.
Anna Hochgraf at akh7@psu.edu
All
18 year(s) or older
N/A
Mental & Behavioral Health, Women's Health
Zip-Stitch for Vaginal Cuff Closure in Laparoscopic Hysterectomy Safety & Efficacy Study
This study will assess the safety and efficacy of the Zip-stitch System in maintaining vaginal cuff closure following laparoscopic hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events and pain. Follow-up will involve in-person visits at approximately one week, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post-operatively.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT04081727
Women's Health
The Influence of Estrogen-Status and Cardiorespiratory Fitness on Endothelial Signaling Pathways
Cardiovascular disease is the leading cause of death in women. Aerobic fitness is generally considered protective of vascular (blood vessel) health, but it is unclear whether this is true in postmenopausal women. The goal of this study is to understand whether aerobic fitness is beneficial for vascular health after menopause by evaluating signaling pathways that may be influenced by both menopause and fitness.
Participants in this study will be healthy postmenopausal women who are either non-exercisers or regular exercisers. For the study, we will ask participants to complete 4 study visits at Penn State University. This will include health screenings, an exercise test, as well as measures of vascular health before and after 1 week of estrogen treatment.
Susan Slimak at sks31@psu.edu or 814-863-8556
Female
18 year(s) or older
N/A
Heart & Vascular, Women's Health
AWS-PSU: Active Women's Study at Penn State University
AWS-PSU: Active Women's Study at Penn State University
This research study is being conducted to evaluate the impact of exercise and reproductive function on bone strength. Eligible young women (age 18-30) are those that are generally healthy and either a) exercising and experiencing regular or irregular menstrual cycles, or b) not exercising and experiencing regular menstrual cycles.
Nicole Aurigemma at nca11@psu.edu or 814-863-4488
Female
18 year(s) or older
N/A
Food & Nutrition, Muscle & Bone, Women's Health
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women in the U.S. and is characterized by both reproductive (anovulation and androgen excess) and metabolic dysfunction (insulin resistance). PCOS lacks a simple, safe and effective treatment for women of all ages and all weights. Recently
a dietary supplement, inositol, has been used widely to treat women with PCOS. However there are no well designed trials to address the risk/benefit ratio and identify the mechanism of action. In this study we propose a 3 month double blind (of both patients and investigators) randomized controlled trial of inositol supplementation compared to placebo. We hypothesis that women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo as well has improvement in glucose tolerance and decrease in fasting insulin.
Amyee McMonagle at amcmonagle@pennstatehealth.psu.edu
Female
18 year(s) or older
N/A
Women's Health
Management Of Pain After Cesarean Trial
This is a double blinded, placebo-controlled randomized controlled trial to test the efficacy of a combination of acetaminophen and ibuprofen administered to patients on schedule compared to ibuprofen and placebo on the patient's reported pain score on the second post-operative day after Cesarean delivery. We will also record opiate consumption and pain scores throughout the hospitalization of participants, and will survey patients at one and two weeks after surgery regarding opiate consumption and quality of life.
Avi Hameroff at ahameroff@pennstatehealth.psu.edu or 717-531-8142, ext=5
Female
All
NCT03929640
Pregnancy & Infertility, Women's Health
Functional and Mechanical Changes Following Total Ankle Arthroplasty
Walking is important for the health of older people. Older adults have been found to walk more slowly as they age. Walking too slowly limits what an older person can do, makes them more likely to fall, and seems to go along with health problems. The calf muscles and the structure of the foot and ankle may be important for walking speed. The calf muscles allow you to push your body off the ground during walking. Foot and ankle structure affect how the calf muscles operate at the ankle.
The properties of muscle, tendon, and even ankle structure have been found to change with age and this might reduce walking ability. Older adults often have weaker muscles that may limit their ability to walk faster. Some surgeries may change the ankle structure and affect the ability to move. This study looks at the effect of ankle structure on walking ability in older adults. The findings may help determine who is at risk for mobility loss and ways to prevent such losses.
Lauren Hickox at walkingstudy@psu.edu or 814-954-0676
All
18 year(s) or older
N/A
Men's Health, Muscle & Bone, Women's Health
Randomized Control Trial of Dietary Supplementation with Dried Plums on Bone Density, Geometry and Estimated Bone Strength in Postmenopausal Women
This 12-month study aims to assess the impact of dried plum consumption of 0-12 dried plums per day on bone density, bone geometry, and bone strength in postmensopausal women. We are recruiting women between the ages of 55 and 75 with normal to low bone mass who are not currently taking osteoporosis medication. Participation in the study involved random assignment to one of 3 different treatment groups (0, 6, or 12 dried plums per day) and participants are asked to visit the lab monthly for various testing procedures.
Kristen Koltun at kxk87@psu.edu or 814-863-4488
Female
18 year(s) or older
NCT02822378
Food & Nutrition, Muscle & Bone, Women's Health
Examining responses to rewards in the laboratory and during daily life in individuals who smoke cigarettes
The goal of this study is to learn more about how people who smoke
cigarettes respond to rewards, such as winning money, under different
conditions. The study uses a method called functional magnetic
resonance imaging, or fMRI, which is a research method for measuring
activity in the brain. In this study, we are using fMRI to measure how
brain activity changes in people who smoke when they receive rewards.
The fMRI measures are collected during two separate visits.
Participants are also asked to fill out questionnaires and complete
computer tasks while in the lab. In total, participants are required
to visit the research lab on the University Park campus a total of
five times. In addition, the study involves measuring thoughts and
behaviors in people who smoke in real life by asking them to fill out
surveys on a smartphone. Participants are asked to carry a smartphone
for a total of 10 days and answer several surveys throughout each day.
In order to be eligible for the study, individuals must be between 18
and 55 years old and you must smoke on a daily basis.
Julian Peck at jnp5021@psu.edu or 814-867-2333
All
18 year(s) or older
N/A
Men's Health, Addiction & Substance Abuse, Women's Health
SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
Endometriosis is a common chronic condition that can cause pain in the lower part of the stomach (pelvis) during the menstrual period and at other times and pain during sexual intercourse.
The purpose of this study is to test how effective and safe the investigational study drug, relugolix (rel-U-GO-lix), given with or without low-dose estradiol and norethindrone is in treating endometriosis-associated pain. Estradiol is a form of estrogen and norethindrone is form of progesterone. Both estrogen and progesterone are hormones normally made by women’s bodies. These hormones help control the menstrual cycle and menstrual periods and also support bone health. The study wants to know if endometriosis pain affects how women function, how they feel and if the study drug is effective and safe at treating the pain from endometriosis.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT03204318
Pain Management, Women's Health
Feasibility Study Phase C: Expansion in Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer
The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System.
Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
Laurie Dove at ldove@pennstatehealth.psu.edu or 717-531-0003, ext=285155
Female
18 year(s) or older
NCT02438358
Cancer, Women's Health
Long-Term Nicotine Treatment of Mild Cognitive Impairment
The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in people experiencing mild memory problems (referred to in this study as “mild cognitive impairment” or MCI).
Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our attention. In people with MCI (and Alzheimer’s disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer’s disease (AD). It has been known for many years that nicotine imitates many of the actions of acetylcholine.
By administering nicotine over a longer period of time to participants with MCI, we hope to better understand whether nicotine may act to improve memory loss symptoms over the longer term and whether it may help to delay the progression of memory loss symptoms.
The amount of nicotine in each patch used in this study is the same as patches that are FDA approved for use in people who are trying to quit smoking.
All
18 year(s) or older
NCT02720445
Men's Health, Neurology, Women's Health
Exploring Facilitators and Barriers to Self-Initiated Sexually Transmitted Infection Testing among College Student
The purpose of this study is to identify modifiable facilitators and barriers to self-initiated sexually transmitted infection (STI) testing among college students aged 18 – 24 years. This study will entail filling out a demographic and sexual history questionnaire, and a private face-to-face interview.
Oluwamuyiwa Adebayo at DAresearch@psu.edu or 814-867-4656
All
18 year(s) or older
N/A
Infectious Diseases & Immune System, Men's Health, Women's Health
Examining Maternal Reward Responsiveness and the Intergenerational Risk for Depression
Children of depressed mothers are at high risk for developing depression, particularly as youth age into adolescence, yet relatively little is known about the mechanism underlying risk for depression in youth with depressed mothers. The present study examines maternal reward responsiveness, measured across neurophysiological, behavioral, and self-report measures as a marker of depression in mothers of adolescents. Associations between maternal reward responsiveness and parenting difficulties often associated with maternal depression, as well as adolescent functioning will be examined, to explore the clinical impact of maternal reward responsiveness on the intergenerational transmission of depression.
Sarah Shahriar at sshahriar1@pennstatehealth.psu.edu or 717-531-0003, ext=285189
All
All
N/A
Children's Health, Mental & Behavioral Health, Women's Health
Postmenopausal women and their endothelium: Is acute dietary nitrate supplementation protective?
Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development.
The purpose of this study is to test the effects of a one time dose of beetroot juice on blood vessel function and resting blood pressure in healthy, postmenopausal women who are within 5 years of menopause. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.
Yasina Somani at yfs5057@psu.edu or 814-954-2930
Female
18 year(s) or older
NCT03644472
Food & Nutrition, Heart & Vascular, Women's Health
Neurocomputational Mechanisms of Affiliation and Personality (NeuroMAP)
This study seeks to learn how brain changes in young adults may be related to the development of interpersonal and emotional functioning, as well as risky behavior. This research is being done to find out the differences in the ways that emerging adults regulate their emotions and behavior and how this is reflected in computer-based tasks and fMRI.
Begonia Herbert-Ramirez at bbh5255@psu.edu or 814-863-7624
All
18 year(s) or older
N/A
Men's Health, Mental & Behavioral Health, Women's Health
A randomized, double-blind, placebo-controlled, phase 2 trial assessing the efficacy, safety and dose-response of quinagolide extended-release vaginal rings administered sequentially for 8 menstrual cycles in women with moderate to severe endometriosis-related pain
To evaluate the efficacy of three doses of quinagolide administered as an extended-release
vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain
Barbara Scheetz at bscheetz@pennstatehealth.psu.edu or 717-531-4483
Female
18 year(s) or older
NCT03692403
Women's Health
Comparing barriers to cancer screening across PSCI catchment area county types: Implications for a self-sampling intervention – Patient surveys
In this study, we will conduct surveys with women, ages 45-65 years, who are patients in the Penn State Cancer Institute (PSCI) catchment area which includes rural/urban and segregated/not segregated counties in Pennsylvania to learn more about their barriers to cancer screening.
Madyson Popalis at casper@pennstatehealth.psu.edu or 717-531-0003, ext=320311
Female
18 year(s) or older
N/A
Cancer, Women's Health
A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain.
The purpose of this study is to look at the safety and efficacy of different doses of linzagolix alone and together with so-called ‘add-back therapy’ (hormones) compared to placebo (an inactive sugar pill) in women with moderate to severe pain associated with endometriosis.
Endometriosis is when tissue that normally grows inside the uterus grows outside the uterus. It is one of the most common gynecological diseases. The condition is mainly found in women in their reproductive years and disappears spontaneously after menopause. Symptoms can include painful periods, chronic pelvic pain, pain with bowel movement, pain during intercourse and urination problems.
Linzagolix is an experimental drug which is not approved for the treatment of moderate to severe pain associated with endometriosis. Linzagolix has been shown to significantly reduce pain associated with endometriosis in women with endometriosis at once daily doses between 50 and 200 mg with a good safety and tolerability profile.
About 450 women will take part in this study at a number of different locations in the US and Canada. This study will have up to 16 study visits over a period of approximately 15 months.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
NCT03986944
Pain Management, Women's Health
M16-824 A phase 3 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.
The purpose of this study is to determine the safety and effectiveness of elagolix 150 mg once daily and how this dosage of elagolix works when compared to placebo in reducing heavy menstrual bleeding, the major symptom of uterine fibroids. Elagolix is an investigational drug which suppresses the production of estrogen depending on the dose. Because Elagolix can reduce the estrogen below the normal level, it is being tested for the treatment of symptoms of endometriosis and uterine fibroids, two conditions are that hormone-dependent.
Participation in this study will last approximately up to 22 months and include approximately 10-12 study visits to the research center and approximately 4 visits that will be conducted over the phone.
Erin Hammett at ehammett@pennstatehealth.psu.edu or 717-531-1510
Female
18 year(s) or older
NCT03886220
Women's Health
Centre County COVID-19 Data 4 Action Study
The purpose of this research is to evaluate the extent of COVID-19 risk and perceived risk among Centre County residents and students, and how those risks evolve from the time isolation guidelines were implemented through a return to normal functioning.
Participants in this research will complete an electronic survey with questions about their demographic, about their exposure to COVID-19, and about how COVID-19 has affected their health and work/education.
Data from this research will be used to inform Centre County planning authorities and the Pennsylvania State University about the needs of communities, including needs for information dissemination and for potentially actionable, local interventions in response to the COVID-19 pandemic.
Susan McHale at src-ssri@psu.edu
All
18 year(s) or older
N/A
Infectious Diseases & Immune System, Men's Health, Women's Health
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.
The aims of the PRIDE Program are to:
1. Create a centralized Biorepository using extra blood obtained from a clinically-ordered blood draw, leftover biospecimens that are removed during medically indicated procedures or a saliva sample from consented participants that do not have clinically ordered blood draws or a medical procedure.
2. Construct a dynamic database of health and related data (via both manual and electronic abstraction) from consented participants.
3. Establish a mechanism for approving use of the banked biospecimens for future research.
Syndi Reed at creed@pennstatehealth.psu.edu or 855-369-3540
All
All
N/A
Men's Health, Children's Health, Women's Health
Comparing barriers to cancer screening across PSCI catchment area county types: Implications for a self-sampling intervention – Patient Focus Groups
In this study, we will conduct focus groups with women, ages 45-65 years, who are patients in the Penn State Cancer Institute (PSCI) catchment area which includes rural/urban and segregated/not segregated counties in Pennsylvania to learn more about their barriers to cancer screening
Madyson Popalis at mpopalis@pennstatehealth.psu.edu or 717-531-0003, ext=320311
Female
18 year(s) or older
N/A
Cancer, Women's Health