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18 Study Matches

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

Healthy Mom Zone: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention Study 2.0

The proposed overall research aims to establish feasibility of delivering an individually-tailored, behavioral intervention to manage gestational weight gain [GWG] that adapts to the unique needs and challenges of overweight/obese pregnant women [OW/OB-PW] and will utilize control systems engineering to optimize this intervention; in other words, make this intervention manage GWG in OW/OB-PW as effectively and efficiently as possible.

You will be randomized into an intervention or attention control group from ~8 weeks gestation to ~37 weeks gestation with a BMI of 25-45 (>40 with physician consent).You will have 1 pre-intervention session that explains the study procedures and to get you ready for the study. Here you will also complete various measures of demographics, behavioral surveys, etc.Over the course of the study, you will weigh yourself each day, wear an activity monitor and complete various surveys. If you are randomized to the intervention group, you may have healthy eating demonstrations and/or physical activity sessions each week.You will have 1 post-intervention session where you will return your devices, complete a 30-60 minute interview and complete the last of the surveys.

$175

Yes
 

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

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT05807594
STUDY00019075
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Inclusion Criteria:
Pregnant
Women
18-45
English speaking
BMI 25-45 (>40 with provider consent)

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
BMI <25
Pregnancy & Infertility, Mental & Behavioral Health, Women's Health
I'm interested
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Altoona, 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 ,

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 814-863-6018
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
I'm interested
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Hershey, PA ,
State College, PA ,

Women and Infants' Stress and Health

The goal of this study is to understand how babies and their mothers learn to respond to stress during the early years of the baby's life. Participating women complete questionnaires and do a mildly stressful task alone (during pregnancy) or with their babies (at four different times over the first two years of the baby's life) and collect saliva samples that tell us about stress responses, either at home or at one of our lab sites. We aim to use what we learn to better support expecting parents who may be at risk for stress-related health problems and improve their children's resilience to stress throughout life.

Women are asked to participate in six sessions over Zoom and/or at the PACT Center between their 28th week of pregnancy and when their child is 2 years old. During these sessions, which last up to 2 hours each, mothers and babies will1.participate in mildly stressful tasks (like having the mother leave the room for up to 3 minutes and then return) and games to assess the baby’s emotional and cognitive development2.provide saliva samples by drooling into a tube (for the mother) or holding a cotton swab in their baby’s mouth to get it wet3.fill out questionnaires about themselves and their baby4.take part in clinical interviews that ask about mood and other markers of psychological ill-being

$220

Yes
 

Heidemarie Laurent
Sandra Rosario - at PRISMlab@psu.edu or 814-867-6482
Human Development and Family Studies (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00019133
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Inclusion Criteria:
Pregnant (up to 32 weeks gestation)
18 or older
English speaking

Exclusion Criteria:
Unable to participate in either Harrisburg or State College study site at 15-24 months postnatal
Pregnancy & Infertility, Mental & Behavioral Health, Women's Health
I'm interested
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Harrisburg, PA ,
State College, PA ,

Smart Connected Water Bottle and Lighting Devices: A Prenatal Pilot Study

We will conduct a pilot study to test feasibility of an innovative light device and blue-light glasses for promoting better sleep and a novel, smart water bottle for proper hydration. We will also examine women’s sleep and hydration behaviors in relation to their perceptions of pain, and obtain feedback from the participants on the overall patient intervention content to reduce prescription opioid use and promote behavioral pain management strategies after delivery.

Currently recruiting pregnant women who are in their 2nd or 3rd trimester.Attend a pre-session (in person OR remote) to explain the use of the water bottle, lighting devices, activity monitors, and weight scaleUse the devices for 22 days and complete surveys in your own homeAttend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days

$100

Yes
 

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

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019938
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Inclusion Criteria:
Pregnant
2nd or 3rd trimester
18-45
Reside around State College, PA

Exclusion Criteria:
Sleep apnea/diagnosed sleep disorders
Diagnosed eating disorders/extreme dietary restrictions
Currently diagnosed with gestational diabetes
Currently diagnosed with pre-eclampsia
Not pregnant
Pregnancy & Infertility, Sleep Management, Women's Health
Survey(s)
I'm interested
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Study Locations

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State College, PA ,

Mindful Moms study

This study (Mindful Moms) is being done to understand how an 8-week app-based mindfulness program called Calm impacts breastfeeding and maternal well-being. Eligible participants will be asked to complete three online surveys (each survey will take about 20 minutes) and take part in an 8-week app-based mindfulness program. Eligible participants will also be asked to take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

Participants will take part in one of two groups: A group asked to take part in a free 8-week app-based mindfulness program on their smartphone starting when they are 36 weeks pregnant or 4 weeks after delivery. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. or A group asked to take part in a free 8-week app-based mindfulness program on your smartphone starting 4 weeks or 12 weeks after they deliver. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. Participants will also be asked to complete three online surveys (each survey will take about 20 minutes) and take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

$130

No
 

Amy Moore
Amy Moore - at amm9107@psu.edu or 814-865-6714
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018380
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Inclusion Criteria:
18 years of age or older
currently pregnant (12 to 34 weeks) or recently delivered (within the past 4 weeks)
intend to or are currently breastfeeding
daily access to a smartphone
willing to download a free mobile app

Exclusion Criteria:
have a current daily meditation practice
Food & Nutrition, Pregnancy & Infertility, Women's Health
I'm interested
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GPRPL Study

The purpose of this study is to find genetic causes of recurrent pregnancy loss (RPL). RPL is defined by two or more miscarriages under 20 weeks gestation and affects approximately 5% of women.The causes of RPL are not well understood. After all the currently recommended testing for RPL has been done, about half of women with RPL will still have no identifiable cause. This lack of knowledge makes it difficult to provide effective medical care for couples with RPL.This study will compare reading about 20000 genes in the entire human genetic library by whole genome sequencing in the miscarriage material and also your and your partner’s DNA from blood samples. The DNA in a person is a combination of the DNA from each of their biological parents. If you have healthy children we may ask your consent for them to give a blood sample for DNA extraction and testing. Similarly, we may ask the same for other family members such as grandparents if necessary. We may also request your permission to use stored DNA or miscarriage material from previous pregnancy loss if available. Testing of family members or previous miscarriage materials may help to understand DNA sequence variants or changes identified in the miscarriage sample.

There will be a one time collection of blood samples.

Yes
 

Sarah Horvath
OBGYNResearch@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
SITE00001050
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Inclusion Criteria:
Women with current pregnancy loss
Two or more prior losses of clinically recognized pregnancies
Prior losses are unexplained

Exclusion Criteria:
Known cause for pregnancy loss and/or prior losses
Pregnancy & Infertility
Prefer not to display
I'm interested
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Hershey, PA ,

Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents.

This is a randomized efficacy trial of a family and alcohol intervention (mFF+) for expecting couples with heavy drinking fathers and light drinking/abstaining (in pregnancy) mothers. We propose to test an innovative preventive strategy by adapting an evidence-based preventive intervention for couples at the transition to parenthood - Family Foundations (FF) - to yield a multi-modal intervention that incorporates alcohol content into existing modules of FF and adding alcohol screening and brief intervention (SBI) for hazardous drinking. This is a multi-PI application with Drs. Eiden (at Penn State) and Godleski (at Rochester Institute of Technology) as co-PIs. Dr. Colder (at the University at Buffalo (UB)) is a co-investigator and will serve as PI of the UB subcontract. Families will be recruited in Western New York (Buffalo and Rochester). Investigators at Penn State (Drs. Eiden and Feinberg) will provide training and supervision. Data management and analyses will occur at Penn State

Couples will be asked to participate in online parenting classes and family assessments during and after pregnancy. There are 3-5 prenatal and 1-4 postnatal classes that take place over Zoom. Family are also asked tp participate in 3 family assessments: 1 during pregnancy, 1 at 6 months of infant age, and one at 12 months of infant age. Families will be asked to complete inline surveys before each assessment. Additionally, families are asked to submit hair and saliva samples.

425.00

No
 

Rina Eiden
Rebecca Lim - at becca.lim@psu.edu or 814-865-6902
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04441307
SITE00000607
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Inclusion Criteria:
Pregnant/Expecting Couples
First time parents
18 years of age or above
English speaking
Both parents living together

Exclusion Criteria:
Below 18 years of age
Not pregnant with first child
Parents not living together
Children's Health, Pregnancy & Infertility, Women's Health
Survey(s)
I'm interested
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See this study on ClinicalTrials.gov

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
I'm interested
Share via email
See this study on ClinicalTrials.gov
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Study Locations

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

Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

This pilot study seeks to determine if formula feeding recommendations that are adjusted using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants.

There will be 5-7 visits, where you will record formula volumes on diary cards for a total of 6 days per visit, and be given formula volume recommendations if you are in the intervention group. All participants will complete surveys when their infants are 1 and 6 months of age.

$300

Yes
 

Ian Paul
Courtney Byrnes - at cbyrnes@pennstatehealth.psu.edu or 717-531-0003, ext=322458
Pediatrics: General Pediatrics (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT05104073
STUDY00018788
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Inclusion Criteria:
Formula-fed infants
Term or Early term Infants (≥37 weeks)
Infant birthweight ≥50th percentile

Exclusion Criteria:
Infants who weigh less than their birthweight between 14-21 days after delivery
Children's Health, Food & Nutrition
I'm interested
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Hershey, PA ,

Coping with it All from Labor to Maternity

The CALM Project is looking to learn how different birthing classes prepare child-bearers for parenthood. Participants attend a free birthing class between their 20th and 37th weeks of pregnancy with their partners and fill out three questionnaires during pregnancy and postpartum. Three months after their baby is born, they are video-recorded interacting with their baby in their home and have their brain scanned using MRI. We aim to understand how different childbirth classes support mothers' well-being and bonding with their babies.

Women are asked to 1.complete 3 self-report questionnaires online during pregnancy and after their baby is born (45 minutes each)2.attend a childbirth preparation class (from a few hours to a 9-week class)3.participate in 2 in-person sessions (1.5 hours each): a videorecording with their baby in the home and a brain scan using MRI at Penn State Hershey Medical Center.

$160 + free birthing class

Yes
 

Heidemarie Laurent
Sandy Rosario - at PRISMLab@psu.edu or 814-867-6482
Human Development and Family Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019138
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Inclusion Criteria:
Less than 28 weeks pregnant
At least 18 years old
Speaks English

Exclusion Criteria:
MRI contraindications (metal implants, brain injury, etc.)
Pregnancy complications that would prevent you from participating in an online class
Pregnancy & Infertility, Women's Health
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Harrisburg, PA ,
Hershey, 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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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 Pauley - 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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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety profile of barzolvolimab (CDX-0159) in patients with active EoE. The study will enroll approximately 60 patients.This study consists of four distinct phases lasting approximately a year. Each patient will receive 1 dose (2 injections) every 4 weeks. The participants will be required to sign the informed consent before any procedures are performed. If eligible for screening, they will need to have standard lab tests (blood and urine), EKG, pregnancy test if applicable, and tests for COVID-19. They will also be required to have EGD with biopsies done during the screening period and at weeks 12 and 28. If eligible to continue, the participants will be randomized on day 1, when they will receive their first treatment. They will be required to come back to the clinic in two weeks and four weeks after that. They will have to complete the e-diary questionnaires at home.

There will be ten in person visits, including screening, placebo-controlled treatment and active (open label) treatment. In addition, there are four follow up visits every 4 weeks. The participants must sign the informed consent. There are going to have vital signs checked at every visit. Some visits have a physical exam. There are blood tests, urine tests, ECG, and COVID -19 tests done. The participants will have EGD procedure with biopsies at screening, and at 12 and 28 weeks of treatment. There will be four study treatments administered in the clinic. The concomitant medications, and adverse events will be monitored and documented. Serum and urine pregnancy tests will be performed if applicable. Participants will be asked to complete electronic diary daily.

$75 per visit; you may receive travel reimbursement $50, and $50 meal compensation for visit 1, 2, 5, 7, and 9

Yes
 

Kofi Clarke
Z. Stella Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05774184
STUDY00022619
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Inclusion Criteria:
Read, understood, and provided written informed consent
Male or female, ≥ 18 years of age
Documented diagnosis of EoE by endoscopy
Must be symptomatic, with dysphagia twice a week
Must have been on a stable diet

Exclusion Criteria:
Diagnosis of hypereosinophilic syndrome
Known active Helicobacter pylori infection
History of achalasia, Crohn’s disease, ulcerative colitis or celiac disease.
Esophageal dilation within 3 months prior to screening visit
Women who are pregnant or nursing.
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE 1B OPEN-LABEL/ PHASE 2 DOUBLE-BLIND PLACEBO-CONTROLLED STUDY FOR PHARMACODYNAMIC ACTIVITY, PHARMACOKINETICS, SAFETY AND TOLERABILITY OF KAN-101 IN PATIENTS WITH CELIAC DISEASE-A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

At this time, there is no treatment available for celiac disease diagnosis. The study is designed to test safety, tolerability and pharmacokinetics of KAN-101 to treat celiac disease diagnosis. We will participate only in the Part C study portion. Part C is a Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response (plasma IL-2) in peripheral blood following gluten challenge, safety, tolerability, and pharmacokinetics (how does drug move in the body) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed celiac disease. Participants will be randomized 1:1:1:1, where one arm is placebo, and other arms are different drug doses. The study consists of a screening period to determine eligibility to participate, a run-in phase where participants are gluten-challenged for one day, a treatment phase where participants will receive a seven-days treatment, and observation period lasting 358 days where participants will have a post-dose gluten challenge on Day 15, and three other time-points. The study aims to enroll 120 subjects across all sites. Participants will be asked to come for the clinic visit, to have gluten challenged done in the clinic, and treatment infusions in the clinic. There are two follow-up visits planned. The participants will have required EGD w/biopsy, and will be offered optional EGD biopsy study, that collects specimens at two time points. All participants will have a blood work done to access eligibility for participation, and to test for drug PK and biomarkers in the response of the treatment. They will also have EKG and physical examinations, vital signs checked during the clinic visits. They will complete questions for patient reported symptoms. Eligible women participants will be tested for pregnancy, and contraception will be discussed for both male and female participants.

Participants will be asked to come to the clinic visits for the screening, gluten challenge, treatment visits and follow up. During the visits, participants will have blood tests done to determine eligibility for the study, or the test how the drug moves through the body and whether it works to dampen the celiac disease symptoms. The patients will have EGD with biopsies procedure done in the endoscopy suite, and they will be offered optional biopsies study. The gluten challenge will consist of drinking a glass of water containing 9g pre-prepared gluten challenge mix. The participants will be observed for four hours. The treatment is done via infusion in the clinic over 30-minutes,and observed for four hours after that. The participants will have to come in for three treatment visits within seven days (days 1, 4, and 7).

$1775

Yes
 

Kofi Clarke
Zvjezdana (Stella) Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05574010
STUDY00022990
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Inclusion Criteria:
subject is aged 18 to 70 years
positive celiac serology and histology
followed gluten free diet for more than a year

Exclusion Criteria:
have refractory celiac
have wheat allergy
have hypersensitivity to gluten
active GI disease
have Type 1 diabetes
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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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 ,

Emotion Regulation During the Transition to Parenthood

The purpose of this study is to understand parents' experiences of emotion regulation in parenting and coparenting contexts and how individual differences in parents' emotion regulation are associated with well-being and relationship functioning.

Coparents will be asked to fill out questionnaires and engage in interviews with the researchers during three online sessions across the transition to parenthood.

110

No
 

Katherine Haigler
Katherine Haigler - at klh6263@psu.edu or 617-817-5218
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024563
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Inclusion Criteria:
You and your coparent are willing to participate
One parent is pregnant and in their third trimester
First-time parents
English-speaking

Exclusion Criteria:
Experiencing a psychotic episode
Pregnancy & Infertility, Mental & Behavioral Health
Not applicable
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