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13 Study Matches

Pilot Study to Assess Medication Adherence, Health Literacy, and Technological Literacy among African Americans and Latinos with Hypertension

This pilot study aims explore the health literacy and medication adherence found among African Americans and Latinos with hypertension receiving care at Hamilton Health Center in Harrisburg PA. We also aim to determine the feasibility of the iPad or smartphone as a tool for accessing health related information among African American and Latino patients with hypertension receiving care at clinics at Hamilton Health Center in Harrisburg PA. The expected outcomes of this project are to obtain a better understand of the literacy levels and adherence behaviors of African Americans and Latinos in Harrisburg, Pennsylvania. The findings from this study will provide valuable insights into the health management behaviors of this community and determine if there is a need to develop a mobile health application for the management of hypertension.

Yes
 

Yendelela Cuffee
Yendelela Cuffee - at ycuffee@phs.psu.edu or 717-531-2044
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00005986
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Inclusion Criteria:
Diagnosed with high blood pressure
Prescribed medication for high blood pressure
African American/Black (Hispanic or Non-Hispanic) or White (Hispanic)
21 years and older
Able to speak and read English

Exclusion Criteria:
Unable to provide consent to participate in the study
Heart & Vascular, Diabetes & Hormones
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Hershey, PA ,

Angiotensin-(1-7) and Energy Expenditure in Human Obesity

We will investigate the effects of the hormone angiotensin-(1-7) on energy expenditure in patients with obesity.

This is an outpatient study that requires a screening visit, and if eligible, one study visit in the Clinical Research Center within the Penn State Health Milton S. Hershey Medical Center. The screening visit will take about one hour and includes a brief physical examination and medical history, urine pregnancy test if female and of childbearing potential, measurement of heart rhythm, collection of blood samples, and measurements of body composition. If eligible based on the results of the screening visit, participants will be invited to participate in one study visit that will take about four hours. Participants will complete food recall and activity questionnaires prior to the study visit and asked not to change eating or physical activity patterns. A urine pregnancy test will be given for females of childbearing potential. Participants will lie down on a bed and a catheter (small plastic tube) will be placed in a vein in each arm to draw blood samples and to give study medications. Equipment will then be placed to measure heart rate, blood pressure, breathing rate, and the amount of oxygen in the blood. After placing this equipment, participants will be allowed to rest for at least 20 minutes. Resting energy expenditure will then be measured by asking participants to breathe through a canopy placed over their head that is connected to a metabolic cart for 45 minutes. Blood samples will be taken to measure hormones influencing resting energy expenditure. Participants will then receive either angiotensin-(1-7) or normal saline (salt water) through the catheter in the arm for up to two hours. Angiotensin-(1-7) is a substance that the body produces naturally; however, in this form, it is considered experimental, which means the Food and Drug Administration has not approved it for this use. Participants will receive either angiotensin-(1-7) or normal saline. The treatment will be randomly assigned meaning that it is determined purely by chance, and neither the participant nor study investigators will know which treatment is received. Blood pressure, heart rate, breathing rate, and oxygen in the blood will be measured continuously while giving angiotensin-(1-7) or normal saline. During the last 45 minutes of the treatment, resting energy expenditure will be measured again and additional blood samples taken. Participants will also have the option of allowing for a small piece of fat to be taken from under the skin in the abdominal region (fat tissue biopsy). Participants will then be allowed to recover for at least 20 minutes and then all equipment will be removed. After the study visit, a nurse will contact participants to check on general well-being and answer any questions.

$25 per hour; additional $75 for fat tissue biopsy

Yes
 

Amy Arnold
Aimee Cauffman - at acauffman@pennstatehealth.psu.edu or 717-531-1617
Neural and Behavioral Sciences (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03777215
STUDY00009895
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Inclusion Criteria:
Men and women of all races
Age 18-60 years
Body mass index between 30-40 kg/m2
Capable of giving informed consent

Exclusion Criteria:
Age less than 18 years or greater than 60 years
Pregnant or nursing women
Current smokers
Type I or type II diabetes
History of major cardiovascular or cerebrovascular disease, immune diseases, impaired kidney or liver function
Heart & Vascular, Diabetes & Hormones
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Hershey, 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 ,

Pathway to Prevention Study

This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials. The study is divided into two parts: Screening and Monitoring. During screening, participants with a 1st degree relative who has type 1 diabetes will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If autoantibodies are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs. If the screening blood tests show that a participant has the autoantibodies, they will be asked to have an Eligibility visit to determine if you can participate in the Monitoring part of the study.

screened for Type 1 diabetes antibodies

Yes
 

Daniel Hale
Clare Robel - at crobel@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Endocrinology (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
NCT00097292
SITE00000066
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Inclusion Criteria:
aged 1-45 years and a sibling, offspring, or parent of an individual with type 1 diabetes
aged 1-20 years and a niece, nephew, aunt, uncle, grandchild, cousin, or half sibling of an individual with Type 1 diabetes
willing to have blood drawn

Exclusion Criteria:
Have previous or current use of medications for the control of hyperglycemia
Currently use immunosuppressive or immunomodulatory therapies
Has diabetes
Diabetes & Hormones
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Hershey, PA ,

Exploring the Immediate Psychosocial and Self-Management Support Needs of Individuals Newly Diagnosed with Type 2 Diabetes (T2D)

To find out the kind of support someone newly diagnosed with type 2 diabetes will need following diagnosis.

No
 

Michelle Boakye
Michelle Boakye - at mdb521@psu.edu or 814-699-1783
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00017593
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Inclusion Criteria:
newly diagnosed with type 2 diabetes(past 12 months)
Age 20 years or older
agree to participate in online focus group

Exclusion Criteria:
old cases of type 2 diabetes
individuals below 20 years
diagnosed with other types of diabetes
Diabetes & Hormones
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Insulitis, Inflammation, Dietary intake and Omega-3 Biostatus of Youth with Partial Remission of Type 1 Diabetes

Only 50% of patients with type 1 diabetes (T1D) recover insulin secretion function after 3 months of initial diagnosis, and this phase is called partial remission (PR) of T1D, also called "Honeymoon phase". During this PR phase of T1D, patients recover the ability to secrete more than 50% of their insulin secretion function. This phase of PR typically lasts no longer than 6 or up to12 months, and has been frequently defined as requiring exogenous insulin below 0.5 units per kilogram per day, and hemoglobin A1C is typically below 7.5%. Most recently the use of a coefficient called IDAA1C ≤ 9 has became more accepted as the methodology to determine the development of partial clinical remission of T1D (honeymoon phase). Prior data published by the SEARCH study (national epidemiological study) showed that youth with prolonged honeymoon phase had higher intake of omega -3 fatty acids, vitamin D intake and leucine intake than those youth without prolonged honeymoon phase of T1D. Currently, there are not approved medications to prolong this phase of partial remission of type 1 diabetes, however inducing PR in youth with T1D could potentially decrease the risk of multi-organ damage caused by chronic severe hyperglycemia associated to the chronic hyperglycemia related to T1D.We aim to perform a case- multiple control study between youth with prolonged partial remission phase of T1D after one year of diagnosis, and compare these youths with multiple controls matched by age, gender, race, and puberty stage to study the potential protective factors associated to the development of prolonged partial remission of T1D.

Participants will be approached at their routine Pediatric diabetes clinic appointment. If participants agrees to be in the research, informed consent/assent will be reviewed and signed by all parties. Participant's parent/guardian will be asked to complete a questionnaire. The participant's glucose machine/insulin pump will be downloaded for study purposes. Participant will undergo a fingerstick and a blood draw to collect specific lab values as outlined in the consent.

$35.00

Yes
 

Lina Huerta-Saenz
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Endocrinology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00014114
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Inclusion Criteria:
Type 1 diabetes diagnosis for more than one year
Age 1-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Most recent hemoglobin A1C below 7.5%

Exclusion Criteria:
Age older than 17 years old
History of seafood allergies and/or milk/dairy related allergies
Medical conditions (such as severe cerebral palsy, etc.) that could make patients unable to communicate with the study team
Existence of other autoimmune diseases in addition to T1D requiring regular treatment with immunosuppressive or anti-inflammatory treatment
Diagnosis of type 2 diabetes, monogenic diabetes (MODY), secondary diabetes, pregnancy, compromised kidney function, or liver diseases
Children's Health, Food & Nutrition, Diabetes & Hormones
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Carlisle, PA ,
Harrisburg, PA ,
Hershey, PA ,

The perception and experiences of newly diagnosed type 2 diabetes patients (T2D) on the impact of patient-provider communication on subsequent decision to engage in diabetes self-management education (DSME).

This study seeks to explore the perception and experiences of newly diagnosed type 2 diabetes patients about how their interaction with their provider at diagnosis led to their uptake of diabetes education.

No
 

Michelle Boakye
Michelle Boakye - at mdb521@psu.edu or 814-699-1783
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00014668
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Inclusion Criteria:
Age 18 or older
Any gender
Newly diagnosed type 2 diabetes patient within the past 12 months
Have attended at least one diabetes education after diagnosis
Able to provide consent in English

Exclusion Criteria:
Patients who are below 18 years
Patients who have a different type of diabetes either than type 2
Patients diagnosed with Type 2 diabetes more than 12 months
Newly diagnosed diabetes patients who have not attended diabetes self-management education
Diabetes & Hormones
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Examining views associated with physical exercise and its connection to diet, social connectivity, and stress reduction: Online Focus Groups

The primary objective of this study is to examine, via online focus groups, the perceptions that are held by potentially-eligible subjects in the PSH DPP program in regard to the importance of physical exercise, particularly within the context of diet, social connectivity, and stress reduction. These perspectives will then be used to help develop, test, and refine additional motivational text messages that can be used in a text messaging intervention. Participants will receive a $25.00 gift card.

No
 

Selena Ortiz
Selena Ortiz - at suo13@psu.edu or 814-863-8041
Health Policy and Administration (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014288
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Inclusion Criteria:
Be at least 18 years old and under age 65
Body Mass Index ≥25 kg/m2 (≥23 kg/m2 if Asian)
Have no previous diagnosis of type 1 or type 2 diabetes
Fluent in English

Exclusion Criteria:
Under 18 years old and over age 65
Body Mass Index <25 kg/m2 (<23 kg/m2if Asian)
Previous diagnosis of type 1 or type 2 diabetes
Not fluent in English
Prevention, Education, Diabetes & Hormones
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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
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 ,

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.

- 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 dropoff- The expected amount of time for participating in the study is 12 hours and 30 minutes in total (~5 to 6 weeks).

$212

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 ,

A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain

A 16 week double blind treatment period to investigate the safety and effectiveness of 3 doses of the study drug vs placebo for endometriosis related pain.

There will be 8 onsite visits and 2 phone visits, blood will be drawn at the onsite visitsThere is an ediary that must be completed every dayStudy exams include a TVU ultrasound, ECG, vital signs, urine pregnancy tests and blood work

$1477.00

Yes
 

Stephanie Estes
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05560646
SITE00001406
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Inclusion Criteria:
premenopausal women
age 18-49
documented surgical diagnosis of endometriosis
moderate to severe endometriosis pain
regular menstrual cycles

Exclusion Criteria:
hysterectomy or bilateral oophorectomy
chronic pelvic pain not endometriosis related
pregnant or breastfeeding
hereditary abnormal hemoglobin or hemolytic anemia
uncontrolled hypertension
Women's Health
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 ,

The Effects of Healthy Diets with Plant Oils on Heart and Metabolic Health

The purpose of this study is to assess if a healthy diet containing cottonseed oil improves markers of heart and metabolic health compared to healthy diets containing other commonly consumed plant oils. Participants will be asked to consume three different healthy diets containing plant oils for 28 days each, with a minimum 1-month break between the three diets. Measurements of blood markers (sugar, insulin, cholesterol), blood pressure, and heart health, will be done at the start of the study and the end of each diet period.

In this study, you will be asked to consume three different diets for 28 days each. The diets will be provided and include 3 meals, 2 snacks and beverages daily. These diets will meet your energy and nutrient needs. You will be asked not to eat any foods outside of what is provided by the study. You will have a minimum 1-month break between the three diets. Testing will be conducted on two consecutive days at the start of the study, and the end of each of the three diet periods (a total of 8 testing days). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours prior. At these visits, we will take a blood draw, measure your body weight, and perform non-invasive tests to assess your vascular health.

500

Yes
 

Kristina Petersen
Janhavi Damani - at dchlab@psu.edu or 866-778-3438
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06216678
STUDY00023998
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Inclusion Criteria:
Age: 25-60 years
BMI: 25-40 kg/m2
LDL cholesterol: 100-190 mg/dL

Exclusion Criteria:
Diagnosis of heart disease, stroke, kidney or liver disease
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy to study foods
Food & Nutrition, Heart & Vascular
Not applicable
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State College, PA ,