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Search Results Within Category "Women's Health"

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56 Study Matches

Effect of Nitrate Supplementation on Cerebrovascular function and Cognitive Function in Older Adults with Metabolic Syndrome

The aim of this study is to determine the impact of cardiometabolic disease risk factors on cognitive performance and brain vascular function, as well as, to see if beetroot juice supplementation can improve these outcomes and reduce risk of cognitive decline and brain vascular dysfunction that is seen with aging and disease.

Participants with and without high blood pressure, high cholesterol, and high blood sugar will be recruited. These are all considered cardiovascular disease risk factors.Individuals without multiple cardiovascular disease risk factors will have 2 visits and complete cognitive and blood vessel function assessments. There involves a blood draw in each visit. All study assessments are non-invasive. Total compensation is $30. Individuals with cardiovascular disease risk factors will have 5 total visits and complete cognitive and blood vessel function assessments. Additionally, participants will drink beetroot juice for 4 weeks to determine the potential health benefits on cognitive, blood vessel function, and metabolic health. There will involve blood draws and all assessments are non-invasive. Total compensation is up to $170.

$30 -170

Yes
 

David Proctor
Jigar Gosalia - at jzg691@psu.edu or 516-816-1654
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05532423
STUDY00020830
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Inclusion Criteria:
Age 55 - 75
high blood pressure and/or high cholesterol and/or high cholesterol
the above criteria does not apply for the control group

Exclusion Criteria:
Smoking
Severe visual impairment
Individuals with any overt cardiovascular, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
Food & Nutrition, Heart & Vascular, Women's Health
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State College, PA ,

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.

No
 

Jessica Salas
Jessica Salas-Brooks - at jis5940@psu.edu or 704-249-4252
Biobehavioral Health (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00006941
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Inclusion Criteria:
Be enrolled at Pennsylvania State University (University Park Campus)
Be between the ages of 18-22 years
Be a female college student
Be sexually active with male partners in the previous 3 months

Exclusion Criteria:
Are not enrolled at Pennsylvania State University (University Park Campus)
Are under the age of 18 or over the age of 22.
Are not a female college student
Are not sexually active with male partners in the previous 3 months
Women's Health
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Interpersonal contrast avoidance of anxiety and depression

This research aims to learn more about your daily thoughts, behaviors, and their impact on social relationships. We want to understand the different qualities of day-to-day thoughts, how these might affect your mood, and how this may influence how you behave in social interactions. We will first ask you to complete a set of structured questionnaires and a brief 30-minute psychological interview via Zoom. This will be followed by a training session in which you will learn how to use your smartphone to track your social interactions and related daily thoughts and behaviors eight times a day for eight days.

You will undergo an initial assessment visit conducted on Zoom, where you will provide informed consent and undergo screening through a brief 30-minute clinical interview. Based on your responses, we will know if you can participate in the study. If eligible, you will be invited to the second part of the study. If so, during the same session, you will then receive a brief half-hour training session reviewing instructions on using a mobile application to complete daily surveys and then complete a series of online questionnaires.When you leave this session, for the next eight days, you will complete eight (approximately 2-minute) questionnaires daily between 10 a.m. and 10 p.m. On the third day, you will attend a compliance check via Zoom to review your progress in the present study.

$20

Yes
 

Adam Calderon
Adam Calderon - at afc6160@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022977
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Inclusion Criteria:
At least 18 years of age
Scores on self-report questionnaires suggest person does or does not struggle with anxiety and/or depression
Owns a smartphone
Fluent in the English language in terms of speaking, listening, reading, and writing.

Exclusion Criteria:
Younger than 18 years of age
Does not own a smartphone
Unable to speak, read, listen, and write English fluently.
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain

18 month trial of elagolix and combined oral contraceptives for women with moderate to severe endometriosis related pain

Subjects will have a screening period of approximately 45 days. If eligible, there will be a 3 month double blind placebo controlled treatment period followed by an open label period of 15 months where all subjects will receive the study medication. Total treatment period is 18 months followed by a one month follow up.Onsite visits are once a month during screening and up until Month 3 when onsite visits will be every 3 months through Month 18.Tests include blood draws at each onsite visit, one ultrasound, an EKG, and 4 DXA scans.

$1475.00

Yes
 

Stephanie Estes
Barbara Scheetz - at bscheetz@pennstatehealth.psu.edu or 717-531-4483
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04333576
STUDY00015216
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Inclusion Criteria:
premenopausal females aged 18-49
diagnosed with endometriosis with moderate to severe pain
regular menstrual cycles
willing to use non hormonal contraception throughout the study

Exclusion Criteria:
currently pregnant, breastfeeding or planning a pregnancy in the next 18 months
osteoperosis or other chronic bone disease
other active chronic pain not related to endometriosis
history of hysterectomy or removal of both ovaries
current or former nicotine user if over age 33
Women's Health
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Hershey, PA ,

Effects of acid sensing ion channels blockade with amiloride on exercise pressor reflex in patients with peripheral artery disease

The purpose of the study is to determine the effects of amiloride on the blood pressure response during exercise, and exercise tolerance in patients with PAD and healthy controls.

There will be 3 in-person visits. You will take a capsule of amiloride or placebo before visits 2 and 3 and blood pressure, heart rate and other physiological measurements will be recorded.

You will receive $25 per hour for your participation in this research study

Yes
 

Jian Cui
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018295
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Inclusion Criteria:
Men and women age 21- 85 years
Any race or ethnicity
Healthy: Free of acute medical conditions
PAD: Diagnosis of PAD, no pain at rest

Exclusion Criteria:
Pregnant or nursing women
Resting blood pressure of 150/100 or higher
Already taking amiloride
Recent heart attack or epilepsy
Peripheral neuropathy
Men's Health, Heart & Vascular, Women's Health
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Hershey, PA ,

Harnessing Artificial Intelligence to Improve Psychiatry

This study intends to improve detection of depression and anxiety by examining speech features recorded by a voice app and analyzing the voice data using cutting-edge artificial intelligence approaches. Eligible participants who are interested in this study will speak on various questions related to lifestyle choices, physical health, and mood to the voice app briefly, fill in some questionnaires, and complete a brief clinical interview. All of the procedures for this one-session study will last up to 90 minutes.

Participants who are eligible based on the screening questionnaire will be invited to participate in a single 1.5 hour Zoom session. During this session, you will be prompted to speak about various topics to a voice app for a few minutes, fill in some questionnaires, and complete a brief clinical interview.

Up to $60 can be earned for completing the 1.5 hour Zoom session. No compensation is given for completing the screening survey.

No
 

Michelle Newman
Jiayin Jiang - at jpj5751@psu.edu or 814-863-0115
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015646
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Inclusion Criteria:
High or low score on measures of anxiety and depression symptoms.
Meets one of the following criteria: 1) Male 2) Black or African American 3) Hispanic, OR 4) Age 23 or older

Exclusion Criteria:
Not applicable
Men's Health, Mental & Behavioral Health, Women's Health
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Singlehood in the Emerging Adult Years: The use of Technology to Communicate

The goal of this study is to understand the use of dating apps in emerging adults (ages 18-29 years old). Using an online survey, participants will be asked a series of questions about their well-being, romantic relationship history, and about their use of dating apps.

You will be asked to take a brief, 15-25 minute online survey, and you may be asked to upload a few screenshots from your phone.

No
 

Nicole Watkins
Nicole Watkins - at nkw5323@psu.edu or 570-963-2573
Social Sciences and Education (SCRANTON)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023596
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Inclusion Criteria:
1.Must be between the ages of 18-29
2.Must be fluent in English
3.Reside in the US
4.Must self-identify as single (romantic relationship status) at the time of participation
5.Must own and use an IPHONE

Exclusion Criteria:
1.Adults over the age of 29
2.Children under age 18
3.Those who do not have an IPHONE
4.Not fluent in English
5.Do not self-identify as single at the time of participation (romantic relationship status)
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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Penn State Exercising Women's Study

This study aims to assess energy status in young sedentary and exercising women as it is related to menstrual status, bone health, psychological health, sleep variables, and cardiovascular function.

There will be three to four visits to the laboratory. Procedures include questionnaires, a blood draw, providing a hair sample, providing two saliva samples, cardiovascular measurements, and bone scans, as well as resting metabolic rate, cognitive, aerobic fitness, and countermovement jump testing. Participants will be asked to collect urine samples throughout one menstrual cycle, or 28 days for amenorrheic females. Exercise and physical activity will be recorded and monitored for seven days via logs and wearables. Food intake will be recorded for three days. Collegiate athletes will be tested twice; in-season and off-season.

Yes
 

Mary Jane De Souza
Ana Carla Chierighini Salamunes - at whel@psu.edu or 814-863-4488
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019437
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Inclusion Criteria:
Women
Age 18-30 years
Body Mass Index between 16-29.9 kg/m2
For sedentary participants: less than 2 hours of purposeful exercise per week and regular menstrual cycles for the last 6 months (i.e. cycles between 26 and 35 days in length)
For exercising participants: exercise at least 2 hours per week AND/OR participate in collegiate athletics. Exercising participants can have regular or irregular menstrual cycles for the last 6 months.

Exclusion Criteria:
Pregnant or lactating
Currently a smoker or history of regular smoking
Taking any hormonal medication in the past six months, other than oral contraceptives
Serious or chronic health condition (including heart condition, thyroid illness, metabolic disease)
Hysterectomy or oophorectomy
Food & Nutrition, Muscle & Bone, Women's Health
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State College, PA ,

A Pre-Post Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

There will be one in person enrollment visit, involving being consented and completion of 2 surveys. The first 3 months, the "baseline period" will include filling out pain scores online on days of endometriosis flare without TENS unit use. The next 3 months, the "treatment period" will include filling out pain scores online on days of endometriosis flare with TENS unit. At end of study completion of 2 surveys.

Yes
 

Kristin Riley
Patricia Rawa - at prawa@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05348005
STUDY00019024
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Inclusion Criteria:
Women aged 18 to 45 years, inclusive,
Surgical diagnosis of endometriosis, visualized and/or pathology confirmed
Having monthly endometriosis pain flares on average
Has never used a TENS unit before for endometriosis pain flares
Must be greater than 12 weeks post-op for abdominal/pelvic surgery

Exclusion Criteria:
Has an implantable device (e.g. pacemaker, etc.)
Has a cardiac arrhythmia
Has open skin sores over area of TENS placement
Not planning to have surgery or hormonal medication changes during the study
Pregnant
Pain Management, Women's Health
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Hershey, PA ,

Endometriosis and microvascular dysfunction 3

Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. Endometriosis is a disorder that is associated with systemic inflammation. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with endometriosis not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. With this study, we will learn how systemic inflammation in endometriosis impairs the lining of blood vessels and increases the risk for cardiovascular disease.We will use a short term intervention with a non-steroidal anti-inflammatory to examine how inflammation impact endothelial function in women with endometriosis

There will be 4 in person visits, at all visits blood will be drawn. Two of the visits will be experimental visits where we will measure skin blood flow and blood flow in the brachial artery. Participants will be required to take a placebo or the drug salsalate for 4 days prior to each experimental visit.

$450

Yes
 

Lacy Alexander
Susan Slimak - at sks31@psu.edu or 814-863-8556
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT05069740
STUDY00018369
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Inclusion Criteria:
Women, 18-45 years of age
With and without Endometriosis

Exclusion Criteria:
Tobacco consumption (e.g. smoking)
Pregnant and/or breastfeeding
Taking blood pressure medication
Known allergy to Salsalate
Heart & Vascular, Pregnancy & Infertility, Women's Health
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Study Locations

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Location Contacts
Altoona, PA ,
Harrisburg, PA ,
Hershey, PA ,
State College, PA ,
Williamsport, PA ,

Testing Responses of Young Adults to Intervention Messages (TRY AIM) Trial

The purpose of this voluntary research study is to determine the effects of different methods of promoting physical activity with wearable devices and technology.

Participants will participate in an 18-month study with virtual study visits.-Use provided digital tools (activity tracker and messages) to monitor physical activity-Set goals to increase physical activity levels based on national guidelines-Monitor weight and complete questionnaires at five times throughout the study (at the beginning, 3 months, 6 months, 12 months and 18 months)

Up to $235 and a Fitbit tracker and BodyTrace scale

No
 

Constantino Lagoa
Gabrielle Ryan - at tryaim@psu.edu or 814-865-7935
Electrical Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05794178
STUDY00019311
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Inclusion Criteria:
Participants capable of reading, speaking and understanding English and of giving informed consent.
Participants between the ages of 18-29 years.
Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
Participants must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time.
Participants interested in setting goals to increase their physical activity levels over the 12-month study.

Exclusion Criteria:
Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
Participants who are pregnant or planning to become pregnant within the next 12 months.
Men's Health, Prevention, Women's Health
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Effects of increased interstitial pressure on venous distension reflex

The purpose of this study is determine if an increase in interstitial pressure has an effect on the venous distension reflex.

This study involves a single visit with 2 trials.You will receive an infusion of saline in your arm before and after a procedure to cause a temporary swelling in your arm.

You will receive $25 per hour for your participation in this research study

Yes
 

Takuto Hamaoka
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019302
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Inclusion Criteria:
Men and women of any race or ethnicity
Healthy (no major disease)
Between 21-60 years old
Weigh over 110 punds

Exclusion Criteria:
Are not between 21-60 years old
Pregnant or nursing women
Have a major disease (heart, lungs, kidney, diabetes, cancer)
High blood pressure
metal implants or claustrophobic
Men's Health, Heart & Vascular, Women's Health
Not applicable
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Hershey, PA ,

The efficacy and safety of a CCT-102 regimen versus expectant management in the treatment of first trimester pregnancy loss

This study will compare the use of CCT-102 with expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL). Eligible participants will be randomly assigned to active treatment or expectant management and will undergo ultrasound, physical examination, sample collection and complete daily diaries.for six days. Participants will be monitored up to 208 days until a negative urine hCG test is achieved.

There are 3 visits and a screening visit which may be combined with visit 1. A physical examination, ultrasound and blood draw will take place at screening and visit 2. Urine pregnancy tests will be taken at screening, visit 1, visit 2 and at home on days 14, 21 and 28 or until a negative result occurs. Electronic diaries will be logged days 1 through 7

595

Yes
 

Stephanie Estes
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT06121063
STUDY00023711
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Inclusion Criteria:
Age 18-50
Hemodynamically stable
Closed cervical os
If fetus exists, gestation <10 weeks by clinical observation
Diagnosis of delayed pregnancy loss based on embryonic demise or anembryonic pregnancy

Exclusion Criteria:
Diagnosis of incomplete or inevitable abortion including more than slight bleeding and or open os
Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
Hemoglobin <10 g/dL, coagulation disorder, chronic adrenal failure
History of allergy or contraindications to use of mifepristone, misoprostol or prostaglandins
Current presence of an IUD
Women's Health
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Hershey, PA ,

Central Pennsylvania Rural Birth Cohort

This study is being conducted to understand what strategies are most successful: 1) in building and retaining a cohort of families from rural communities in Central Pennsylvania with recruitment beginning in pregnancy, infant/toddler age, and preschool age using a cohort sequential design; 2) for collecting clinical and semi-invasive, remote-based biobehavioral measurements to better characterize synergistic factors associated with obesity and substance use in this high risk population; and 3) for identifying points for future intervention, treatment, prevention, and policy efforts to reduce health disparities in maternal-child morbidity and promote positive family processes.

Cohort 1 (Pregnancy Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 16-weeks gestation. You will complete online surveys. The surveys should take 1 hour or less.. Visit 2 will occur around 32-weeks gestation. You will complete online surveys, and a semi-structured health behaviors interview via Zoom. You may also be asked to collect hair and/or nail samples. The visit should take 2 hours or less. Visit 3 will occur around 6 months post-delivery. You will complete online surveys. The surveys should take 1 hour or less. Visit 4 will occur around 12 months post-delivery. You will complete online surveys and a parent-child interaction observation (one session). This visit should take 1 hour or less.Cohort 2 (12 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 12 months post-delivery. You will complete online surveys, and a parent-child interaction observation (one session). You may also be asked to provide hair and/or nail samples. This visit should take 2 hours or less. Visit 2 will occur around 24 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.Cohort 3 (24 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 24 months post-delivery. You will complete online surveys. You may also be asked to provide hair and/or nail samples. This visit should take 1 hour or less.Visit 2 will occur around 36 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.All electronic health record data will be extracted at the end of study participation.

$100-200

No
 

Danielle Downs
Birth Cohort Team at birthcohort@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00020841
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Inclusion Criteria:
Pregnant person over age of 18 with a singleton pregnancy
Over the age of 18
Families with toddlers that are either 12 or 36 months of age
Live in rural Pennsylvania
Have smartphone/wifi access

Exclusion Criteria:
Not pregnant or multiple pregnancy
Pregnant person or parents under age of 18
Families without toddlers that are either 12 or 36 months of age or a multiple (twin, triple, etc.)
Live outside of rural Pennsylvania
Do not have smartphone/wifi access
Children's Health, Pregnancy & Infertility, Women's Health
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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.

No
 

Amber O'Shea
Amber O'Shea - at amo5208@psu.edu or 814-867-5721
Educational Psychology, Counseling and Special Education (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00011286
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Inclusion Criteria:
Currently enrolled as a college student
18 years of age or older
Capable of providing informed consent
Diagnosis of a disability
Able to understand written English

Exclusion Criteria:
Adults unable to provide legal consent
Individuals who are not yet legal adults
Pregnant women
Prisoners
Education, Mental & Behavioral Health, Women's Health
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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. Recentlya 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.

There will be 4 in person visitsHave a physical exam and other evaluations, including ultrasoundTake study drug as directedHave bloodwork taken throughout studyComplete questionnaires and a daily diary

$300

Yes
 

Richard Legro
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03864068
STUDY00010252
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Inclusion Criteria:
Women 18-45 years old
Diagonosed with Polycystic Ovary Sydrome
8 or less periods per year
Periods of greater than or equal to 45 days
Not seeking pregnancy

Exclusion Criteria:
High protactin levels
Uncorrected thyroid disease
Suspected adrenal or ovarian tumor screting androgens
Suspected Cushing's syndrome
Contraindications to the study drug or placebo
Women's Health
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Hershey, PA ,

The HEALthy Brain and Child Development Study (HBCD)

This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, willprospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatallythrough age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmfulas well as protective environmental factors. These include prenatal substance use, mental health, stress,sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is tounderstand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will befollowed for 10 years.

If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.

$1,350

Yes
 

Koraly Perez-Edgar
hbcd@psu.edu;hbcd@pennstatehealth.psu.edu 814-826-1422
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
SITE00001129
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Inclusion Criteria:
Pregnant or recently gave birth
Speaks English or Spanish

Exclusion Criteria:
Is not pregnant or does not have newborn
Does not speak English or Spanish
Children's Health, Pregnancy & Infertility, Women's Health
Not applicable
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Study Locations

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Location Contacts
Hershey, PA ,
State College, PA ,

Identifying the Cognitive, Psychological, and Neuroimaging Signatures of Head Trauma in Female Survivors of Intimate Partner Violence

We aim to investigate the impact exposure to head trauma in intimate partner violence (IPV) has on cognitive, psychological, and neural processes. Physical trauma as an outcome of IPV impacts an estimated 10 million people in the United States each year, with up to 90% of women exposed to IPV reporting episodes of abuse with head trauma. Women exposed to IPV are at a high-risk for developing mental illness and impaired cognitive function, which seems to be compounded in those with exposure to head trauma (HT).

The study includes interviews to discuss your any experiences you have had with physical abuse and head trauma, as well as current and past mental health history. Then you will complete questionnaires to see how you feel about your mental and physical health, followed by tests to assess your thinking abilities. Finally you will complete a magnetic resonance imaging (MRI) session to examine brain structure and function. All of the testing should take approximately 6 hours to complete.

$90

Yes
 

Frank Hillary
Elizabeth Rebuck - at exr5373@psu.edu or 814-865-0389
Psychology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00000844
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Inclusion Criteria:
Female
Aged 18-60
Has previously experienced intimate partner violence

Exclusion Criteria:
Male
Currently experiencing intimate partner violence (within the past 3 months)
Non-English speaker
Neurological and developmental disorders
Neurology, Mental & Behavioral Health, Women's Health
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Altoona, PA ,
Hershey, PA ,
State College, PA ,

Prospective Cohort Assessing Novel Biomarkers of Early Pregnancy

The purpose of this research is to take and store blood, urine samples from pregnant women diagnosed by a positive pregnancy test or by ultrasound imaging. The purpose of this study is to determine a better way to diagnose the location and/or viability (chance of survival) of a pregnancy, as compared to current clinical care. Many women are found to be pregnant by a hCG (human chorionic gonadotropin) test which detects a hormone that is indicative of pregnancy. However, in early pregnancy, it is often difficult to see the pregnancy by ultrasound, which is called a pregnancy of unknown location (PUL). In early pregnancy, doctors do many tests (including blood tests and ultrasounds) to try to determine how far along the pregnancy is, whether it is healthy, and most importantly whether the pregnancy is growing in the right place. The doctors running this research project are trying to see if there are substances (biomarkers) in the blood or urine of a pregnant woman that can tell whether the pregnancy is a normal, healthy pregnancy, an ectopic pregnancy, or if pregnancy is not viable (miscarriage). To do this, blood and/or urine samples are being collected from women who have a pregnancy of unknown location, an ectopic pregnancy, women who are having a miscarriage, and women with a healthy growing pregnancy. The study will then look at a pre- determined panel of biomarkers that have been shown to be elevated (higher) or decreased (lower) in different types of pregnancy to determine the effectiveness and accuracy of this test in earlier diagnosing the viability and location of early pregnancy.

There will be one visit at the visit participants will be consented and following consenting blood and urine will be collected.

$25.00

Yes
 

Sarah Horvath
OBGYN Research at OBGYNResearch@pennstatehealth.psu.edu or 717-531-0003, ext=320358
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00018551
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Inclusion Criteria:
Pregnancy diagnosed by a positive serum human chorionic gonadotropin (hCG) test
Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
Diagnosed ectopic pregnancy
Pain or bleeding or at risk for ectopic pregnancy
Women seeking confimation of a pregnancy with a urine or serum pregnancy test (less than 14 weeks)

Exclusion Criteria:
Not a Penn State Health Patient
Pregnancy & Infertility, Women's Health
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Hershey, PA ,

Behavior, Voice, and Sex Hormones Study

Hormones are molecules that deliver signals throughout the body. They influence behavior, sleep, hunger, stress, and virtually all other aspects of life. This study seeks to better understand several of these functions, specifically how hormones affect specific aspects of human behavior and psychology, as well as speech production. Following an initial lab visit, subjects will participate in the remainder of the study (~5 weeks) at home via the internet. On a daily basis, they will collect urine samples for hormone analysis, saliva samples for analysis of oral micro-organisms, and will submit voice samples for analysis of speech (e.g. measuring voice pitch and loudness). They will then complete an online survey designed to collect information about their behavior, and attitudes over the previous 24 hours. Subjects receive compensation for their participation.

- Compensation $330 at maximum- Pre-sampling lab visit to sign a consent form and receive training- A series of ~42 daily at-home sample (urine, saliva) collection &amp; online surveys- Weekly lab visits for sample drop-off

$330

Yes
 

David Puts
Sojung Baek - at research1871@psu.edu or 814-321-5541
Anthropology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013693
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Inclusion Criteria:
Between 18 and 30 years of age
Normal menstrual cycles
Available for daily at-home session for approximately 5 weeks
Female/Identifying as a woman
Predominantly or exclusively heterosexual sexual orientation

Exclusion Criteria:
On hormonal birth control
Uncorrected severe defects of hearing, speech, or vision
Bisexual or predominantly homosexual sexual orientation
Very heavy smoking or alchohol consumption
Medications that affect levels of ovarian hormones (e.g. anti-depressants, anti-psychotics)
Language & Linguistics, Diabetes & Hormones, Women's Health
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State College, PA ,

Understanding Prenatal Hydration Behaviors

To examine women’s self-reported pregnancy hydration behaviors, especially during a global pandemic. This study will also examine other lifestyle behaviors (e.g., weight gain, exercise, eating behaviors, sleep, pain management). It is hypothesized that hydration behaviors will decrease due to lifestyle changes related to the pandemic. Secondary outcomes will also be influenced by hydration behaviors and pandemic lifestyle changes.

No
 

Danielle Downs
Abigail Pauley - at amp34@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016174
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Inclusion Criteria:
Pregnant
Women
18-45
English speaking

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
Food & Nutrition, Mental & Behavioral Health, Women's Health
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Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines

The purpose of this study is to test if estrogen supplements can help reduce blood pressure and inflammation in postmenopausal women.

•Two lab visits for vascular function measurements•Wear an estradiol or placebo patch for one week.

$25 per hour for the study visits plus $50 if all microdialysis experiments are completed

Yes
 

Lu Qin
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06369363
STUDY00024245
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Inclusion Criteria:
Women 54-75 years old
Healthy
Classified as postmenopausal: stopped having period >1year or had a full hysterectomy surgery
Free of acute medical conditions

Exclusion Criteria:
On hormone replacement therapy
Smoker
Have cardiovascular or metabolic disease
History of gynecological cancers
History of long-term menstrual irregularities
Heart & Vascular, Women's Health
Approved drug(s)
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Hershey, PA ,

Endometriosis and microvascular dysfunction

Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.

There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.

390

Yes
 

Lacy Alexander
Susan Slimak - at sks31@psu.edu or 814-863-8556
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05059626
STUDY00018347
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Inclusion Criteria:
Women, 18-45 years of age
Endometriosis

Exclusion Criteria:
Tobacco consumption (e.g. smoking)
Pregnant and/or breastfeeding
Taking blood pressure medication
Heart & Vascular, Pregnancy & Infertility, Women's Health
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Altoona, PA ,
Harrisburg, PA ,
Hershey, PA ,
State College, PA ,
Williamsport, PA ,

Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers

The purpose of this research study is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. Participants will be asked to reduce their cigarette smoking by at least 50% with the help of the nicotine pouches.

After smoking your usual brand cigarettes for one week, you will be randomly assigned to one of six nicotine pouch groups to use over 16 weeks and asked to reduce your cigarette smoking over that time by at least 50% by using a nicotine pouch in place of your cigarettes. During the 16 weeks, there will be 2 phone call contacts and 4 in-person study contacts. During in-person contacts you will complete study questionnaires and you will be asked to provide urine, exhaled carbon monoxide, mouth cell samples, and other health measurements. You will record your cigarette and nicotine pouch use every day through a daily text message. Lastly, you will be followed up for a last study contact (virtual) 4 weeks later.

$375

Yes
 

Jonathan Foulds
Nicolle Krebs - at smokingresearch@pennstatehealth.psu.edu or 717-585-0416
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06043362
STUDY00023056
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Inclusion Criteria:
Ages 21-70
Commonly smoke ≥ 5 cigarettes or little cigars/cigarillos per day (at least 2 days/week) for at least the prior 12 months
Smoke cigarettes daily
Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
Access to e-mail and a smartphone/computer that has reliable internet connection

Exclusion Criteria:
Has a firm plan to quit within the next 30 days when assessed at screening
Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days
Currently pregnant, breastfeeding, or planning to become pregnant
Use of any FDA-approved smoking cessation medication (including any nicotine replacement therapy or varenicline, bupropion or nortriptyline used specifically as a smoking cessation aid) in the prior month
Use of illegal drugs daily or weekly in the past 3 months
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Women's Health
Not applicable
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Hershey, PA ,

Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women

The new program will help women who have recently been involved in the criminal justice system and use opioids (heroin, fentanyl, prescription pain medications nonmedically) to join treatment programs for opioid addiction. The program will also assist women in finding and getting access to the social services they may need and provide opioid response training. Half of the recruited participants will be randomly selected to be in a trauma support group for women with addiction issues. The program will also help women with common barriers to staying in treatment, such as childcare and transportation.

Participants will be connected to drug treatment programs that offer medications to stop or reduce drug use. Participants will be assigned a peer recovery specialist; these are women in long-term recovery who will help the enrolled women with transportation, childcare, and completing any tasks they may have due to criminal justice involvement or child welfare. Half of our participants will be assigned to a support group of other women in recovery. Participants will complete surveys at three time points and will be paid $50 each time. Participants will also be given overdose response training and take-home-naloxone.

$575

Yes
 

Abenaa Jones
Abenaa Jones - at avj5462@psu.edu or 202-956-8557
Human Development and Family Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00023933
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Inclusion Criteria:
Female
Use heroin, fentanyl, or prescription opioids without a prescription
interested in medications to reduce opioid use
18 years or older
live in Harrisburg area

Exclusion Criteria:
Not interested in medications to stop opioid use
not female
not older than 17
Addiction & Substance Abuse, Mental & Behavioral Health, Women's Health
Survey(s)
I'm interested
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Carlisle, PA ,
Harrisburg, PA ,
York, PA ,

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women with Infertility Due to Polycystic Ovary Syndrome

This is a randomized trial whereby a study device will be used to remove tissue from the ovary via a transvaginal ultrasound procedure in order to promote/restore ovulation in women with infertility due to PCOS. Weekly serum blood draws will also be obtained to determine ovulation rates during the first 12 weeks of study enrollment. Those randomized to the control arm will have the option of crossing over to the device arm after 3 months.

Preliminary visit to assess eligibility followed by randomization into the Device or Control Arm. Device Arm requires May Health procedure (approximately 1 hour long, similar to ovarian drilling) followed by 12 weekly blood tests and 6 follow up clinic visits and follow up calls for up to 36 months after the procedur4e. Control Arm requires 12 weekly blood tests and the option to cross-over to the device arm after 3 months. If no cross-over occurs, the control arm will have one follow up visit at 3 months and can then exit the study. Both arms will complete questionnaires and log menstruation dates in an e-diary.

1220

Yes
 

Stephanie Estes
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06206746
STUDY00023415
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Inclusion Criteria:
18-40 years of age
Infertility associated with oligo or anovulation and ultrsonographic evidence of PCOS or evidence of hyperandrogenemia
At least one ovary with volume greater or equal to 10.0ml
Ovarian accessibility by transvaginal ultrasound transducer
Has not responded to first-line ovulation induction treatment

Exclusion Criteria:
Currently pregnant
BMI greater than 40
Marked hyperandrogenism
Poor glycemic level control (greater than 6.5%)
Bleeding disorders
Women's Health
Experimental device
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Hershey, PA ,