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AREN2231: Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

The purpose of this study is to improve the treatment of children and young adults with all stages of FHWT, so that more patients are cured without relapse, and that side effects from treatment are lessened without decreasing cure rates. This study will use information on higher or lower risk features of FHWT to adjust the treatment of each subject based on their risk of relapse.

All patients will receive chemotherapy (regardless of stratum assignment) starting with 1 cycle (3 weeks) of VA (vinCRIStine, DACTINomycin) chemotherapy. Some patients will have changes in treatment based on information learned after enrollment. For all patients, at least one callback is required to be completed prior to randomization and/or prior to any change in treatment or continuation of the same treatment.

Yes
 

Lisa McGregor
cra@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06401330
STUDY00026986
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Inclusion Criteria:
Patients must be <30 years old at enrollment
Patients must have newly diagnosed Stage I-IV Favorable Histology Wilms Tumor

Exclusion Criteria:
Patient with a diagnosis of Stage V Bilateral Wilms Tumor
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
Patients with known Charcot-Marie-Tooth syndrome
Patients receiving concurrent chemotherapy for a different diagnosis.
Children's Health, Cancer
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Hershey, PA ,

BLack families Overcoming Obstacles through Mothers' Strengths (BLOOMS)

The purpose of this pilot study is to test women of color's willingness to participate in web- and laboratory-based assessments of their experiences with adversity, their cognition, indicators of poor mental and physical health, risky behaviors during pregnancy, and how they cope with stressful situations. If participants have a 3-to-5-year-old child, we will also ask if they would like their child to participate in various thinking games and biological data collection. If so, we will also assess their preschool-aged child's willingness to participate in various protocols, comprehension of protocol instructions, and ability to complete various tasks.

There will be one in-person visit to the Biobehavioral Health building to collect: -Questionnaires -Height, weight, and waist circumference -Blood pressure -Complete a challenge task -Cognitive tasks -Heart rate monitoring Participants will be asked to complete 7 days' worth of daily assessments on their phone after their in-person study visit. After completing the daily assessments, participants may be selected to participate in a follow-up interview about their experiences throughout the study. Participants will be compensated for their participation in all three portions of the study (in-person visit, daily assessments, and follow-up interview).

$88

Yes
 

Gabriela Revi
Gabriela Revi - at BLOOM@psu.edu or 814-343-1549
Biobehavioral Health (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027101
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Inclusion Criteria:
Identify as Black
Fluent in English
Ages 18-64
Lives in Centre County
Identifies as a woman

Exclusion Criteria:
Does not identify as Black
Does not identify as a woman
Discomfort with having a heart monitor on their chest
Does not have a smartphone
Food & Nutrition, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents

The overarching goal of this research is to adapt, optimize, and pilot a transdiagnostic sleep and circadian intervention so that its contents and delivery are effective and sustainable for autistic adolescents

Participants will complete assessments at two time points and engage in a 6 week behavioral sleep intervention with a trained clinician.

$75.00

Yes
 

Kristina Lenker
KRISTINA LENKER - at klenker2@pennstatehealth.psu.edu or 717-531-0003, ext=280299
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00027612
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Inclusion Criteria:
Diagnosed with Autism
Sleep problems
Ages 13-17 yrs
English speaking

Exclusion Criteria:
A history of IQ < 70
A history of psychotic, bipolar or seizure disorders
Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome
Children's Health, Sleep Management, Mental & Behavioral Health
Not applicable
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Hershey, PA ,

PSCI 23-146 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

this trial will compare Pembrolizumab with and without MK-2870 in participants with lung cancer for disease free survival.

Participants will be required to com to all study visits, report all medications they are taking, including over the counter medications and tell the study team how they are feeling.

$50 for each completed visit

Yes
 

Takefumi Komiya
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06312137
STUDY00026209
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Inclusion Criteria:
Has histological or cytological confirmation of squamous or nonsquamous NSCLC,
Able to undergo surgery based on opinion of investigator after consultation with surgeon.
Able to receive pembrolizumab and platinum-based chemotherapy
Has not achieved pathologic Complete Response at surgery
18 years of age

Exclusion Criteria:
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome,
Has active inflammatory bowel disease
Has active inflammatory bowel disease
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy

This study is being done to answer the following question: Does the use of Olaparib for one year keep your ovarian cancer from growing or returning as well as the usual approach of two years? If you decide to take part in this study, you will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until your disease gets worse or the side effects become too severe. After you finish your treatment, your doctor and study team will watch you for side effects. They will check you every 3 months for 2 years after treatment. After that, they will check you every 6 months for 3 years. This means you will keep seeing your doctor for 5 years after treatment.

The patient will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until their disease gets worse or the side effects become too severe. The doctor and study team will watch for side effects. They will check every 3 months for 2 years after treatment. After that, they will check every 6 months for 3 years. This means checking with the doctor for 5 years after treatment.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06580314
STUDY00027597
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Inclusion Criteria:
Patients with newly diagnosed, pathologically confirmed, FIGO Stage III or IV ovarian cancer of the following types:
high grade serous, high grade endometrioid, and/or other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic).
Patients must have: 1) Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration).
OR 2) BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory (e.g., Myriad MyChoice©)
Patient must have undergone cytoreductive surgery (primary or interval).

Exclusion Criteria:
A patient cannot be considered eligible for this study unless ALL of the enrollment inclusion criteria conditions are met.
Cancer
Approved drug(s)
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Hershey, PA ,

Characterizing the effect of an electrolyte and carbohydrate-based hydration beverage on hydration status in young adults.

This study will determine how well water, an electrolyte and carbohydrate based drink, and an electrolyte only drink hydrate the body. This study will measure how long the water from these drinks stay in your body. We will look at different hormones and electrolytes in the blood and urine to determine which drink keeps fluid in your body the longest.

There will be 4 in person visits. The first is a screening visit which will take about an hour. During the next three visits we will have you drink 1 L of a beverage and we will measure your blood and urine for a few hours after you drink it to determine how well it hydrates you. There will be a blood draw at each of the 4 visits.

150

Yes
 

William Kenney, Jr.
Kat Fisher - at kgf5118@psu.edu or 307-203-7657
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00027463
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Inclusion Criteria:
Healthy
Regularly Active
18-40 yrs old
Men and women

Exclusion Criteria:
cardiovascular, kidney or digestive disease
Pregnancy and breastfeeding
smoking
diuretics
prostate issues interfering with urination
Food & Nutrition
Not applicable
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State College, PA ,

PSCI 24-076 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) (IDeate-Esophageal01) (A PHASE 3 STUDY OF I-DXD IN SUBJECTS WITH PRETREATED ESCC)

This trial will be examining the use of a drug, ifinatamab in the treatment of patients with advanced or metastatic esophageal squamous cell cancer.

After signing consent, participants will have blood tests and scans to see if they are well enough to participate. If the participate, they will need to come to the clinic to see the study team then get the experimental treatment. Participants will continue treatment until the medication no longer works, they no longer want to participate, or the study doctor feels it is not safe for them to continue.

Yes
 

Nelson Yee
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06644781
STUDY00026270
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Inclusion Criteria:
Subjects aged ≥18 years
Has histologically or cytologically documented unresectable locally advanced (Stage II to IVA if T2-T4 or N1-3 M0), or metastatic (Stage IVB) ESCC
Has disease progression post platinum-based and ICI treatment

Exclusion Criteria:
Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
Has received any topoisomerase inhibitor.
Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI # 25-038 A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This trial will examine which combination is better in treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Sorotoclax or Venatoclax.

There are three parts to this study. Screening, when you will meet the study team, sign the consent for and have tests performed to make sure that it is safe for you to participate in the study. If you join the study you will be chosen to participate in one of four arms, each with different medication to treat you disease. During the first cycle of treatment you will need to be seen by the study team between 4 and 7 times, depending upon the treatment. You will continue on the study medication until it no longer works, you have finished the trial or the doctor feels that it is no safe for your to continue ( among other reasons). The third part of the study is follow up. you will have a study visit in the clinic 30 after the last day of taking the study drug. That will be followed by after treatment follow up visits every three months until your cancer returns, if it returns. Then you will be followed every three months to see how you are doing.

Yes
 

Joseph Cioccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06943872
STUDY00027116
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Inclusion Criteria:
Must be ≥ 18 years of age
Must have confirmed diagnosis of CLL/SLL
Must have received ≥ 1 prior therapy for CLL/SLL
Must not have received any maintenance therapy.

Exclusion Criteria:
Patients who have active symptomatic COVID-19 infection
Patients with a history of confirmed progressive multifocal leukoencephalopathy
Prior allogeneic stem cell transplant with active GVHD
Received a live, attenuated vaccine within 4 weeks
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 3, External and Synthetic Placebo-Controlled Randomized Study with Dose-Up for Non-Responders to Investigate Safety and Efficacy of Ritlecitinib 50 mg and 100 mg Once Daily in Adult and Adolescent Participants 12 Years of Age and Older with Alopecia Areata

Alopecia areata (AA) is an autoimmune disease that causes non-scarring hair loss that can be relapsing and chronic. It affects patients of all ages, races, and genders. Symptoms can range from patchy hair loss usually affecting the scalp, to complete scalp hair loss (alopecia universalis) or complete loss of hair on the scalp, face, and body (alopecia totalis). AA has a detrimental impact on patients' emotional wellbeing, self-esteem, social interactions, and quality of life, and psychiatric conditions such as anxiety and depression are more common in patients with AA compared to healthy controls. The purpose of this study is to find out if the study medicine, Ritlecitinib, can help with the treatment of AA.

Study participation will last approximately 57weeks. During the study, participants will attend 9 in person visits in the research office. At different timepoints the participant will have their hair examined, blood drawn, have an ECG and chest x-ray done, have photos taken of their scalp and face, answer questionnaires, and take study medication as directed by the study team.

Yes
 

Jeffrey Miller
DermatologyClinicalTrials@pennstatehealth.psu.edu 717-531-5136
Dermatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06873945
STUDY00026810
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Inclusion Criteria:
Be at least 12 years of age
At least 50% hair loss on the scalp with no regrowth for at least 6 months
Current episode of hair loss no longer than 10 years

Exclusion Criteria:
Other types of hair loss such as androgenetic alopecia, traction and scarring alopecia, or telogen effluvium
Other scalp conditions that could interfere with alopecia assessment
Certain medications are not allowed; study coordinator will discuss
Skin Conditions
Experimental drug compared to an approved drug
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Hershey, PA ,

A Community-Based Pickleball Program for Adults with Autism Spectrum Disorder

This study will test whether playing pickleball, a fun and easy-to-learn paddle sport, can improve physical coordination and reduce core autism symptoms in adults with autism spectrum disorder (ASD). Participants will be placed in either an early start group or a delayed start group using a delayed control trial design. The early start group will attend two 90-minute pickleball classes per week for the first 8 weeks and then resume regular activities for the next 8 weeks. The delayed start group will continue regular activities for the first 8 weeks and then transition into the pickleball classes for 8 weeks. All participants will complete pickleball skill assessments at their first and last class to measure improvement, and three testing sessions during the study will assess sensory-motor processing, autism symptoms, mental health, and quality of life. By comparing the two groups, this study aims to determine whether pickleball supports better physical and emotional health for autistic adults and whether it can help participants feel more confident, connected, and engaged in social settings.

Participants will attend three in-person testing sessions (baseline, mid-study, and post-study) where they will complete surveys and a videogame-based sensory-motor assessment. They will also participate in two 90-minute coach-led pickleball classes per week for 8 weeks. Pickleball skill assessments will be completed during their first and last pickleball class.

$100

Yes
 

Christopher Sciamanna
Daniel Lidstone - at dbl5689@psu.edu
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027574
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Inclusion Criteria:
Adults aged 18–45 years
Clinical diagnosis of autism spectrum disorder (ASD)
Able to participate in group activities without caregiver support
Able to understand and communicate in English
Available and able to attend at least two pickleball sessions per week during the 8-week program

Exclusion Criteria:
Currently playing a ball or racquet sport at least once per week
Use of mobility aids that limit court-based movement
Moderate-to-severe joint pain
Neurological conditions (e.g., cerebral palsy, epilepsy, severe head injury)
Clinical diagnosis of intellectual and developmental disability
Neurology, Sleep Management, Mental & Behavioral Health
Not applicable
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Harrisburg, PA ,
Hershey, PA ,

Effects of catheter ablation on cardiopulmonary afferents in patients with atrial fibrillation

Catheter ablation for patients with atrial fibrillation (AF ablation) is an effective treatment to improve abnormal heart rhythm (i.e., atrial fibrillation, AF). Autonomic nervous system controls things your body does automatically without thinking, such as regulate heart rate, blood pressure, and respiratory control.It has been reported that AF ablation might improve abnormal autonomic nervous system in patients with AF in addition to improve abnormal heart rhythm. However, the detail is still unclear. In the proposed study, we aim to verify the effect of AF ablation on autonomic nervous system in patients with AF. We will evaluate autonomic nervous system using various approaches in AF patients before and after AF ablation, as well as healthy subjects. The results obtained from this study will provide important insights into the research area of AF treatments.

Patients with atrial fibrillation will have three visits to the research lab with each visit lasting 3-3.5 hours. • Visit 1 (pre-AFib ablation): will occur about 1-2 weeks prior to your procedure • Visit 2: approximately 1 month after your ablation procedure • Visit 3: approximately 3 months after your ablation procedure Patients who are healthy volunteers will ONLY have one visit to the research lab that lasts 3-3.5 hours. Various physiological measurements will be recorded during this time including microneurography, blood pressure, heart rate and blood flow.

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
NCT00000000
STUDY00026734
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Inclusion Criteria:
Males and females (including females taking oral contraceptives)
50-85 years of age
Are of any race or ethnicity
Capable of speaking English
Capable of giving informed consent

Exclusion Criteria:
Pregnant or nursing woman
Incapable of speaking English
Decisional impairment
Age < 50 or > 85 years old
Have any history of chronic diseases including heart failure, severe lung diseases, renal failure, peripheral neuropathy, epilepsy or seizure disorders and other chronic diseases
Heart & Vascular
Not applicable
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Hershey, PA ,

Platform Wars: Evaluating postural and strength adaptations with Wii Fit Balance vs. Whole-body vibration in college students.

This study will aim to see if there is a difference in strength and balance changes among college students when comparing the Wii Fit Balance and whole-body vibration training.

The study duration will be six-weeks, in which study participants will be involved in either a gaming training group or a vibration platform training group. Participants will complete a baseline session and post-training assessment, each lasting two hours. During both of these visits measures of balance, strength, and walking ability will be acquired. In the six weeks of the study,18 individual vibration or gaming training sessions will be completed. The respective training sessions will take place three times a week for 6 weeks and will last 10-minutes each.

$20.00

Yes
 

Fabricio Saucedo
Fabricio Saucedo - at fns5045@psu.edu or 814-201-7065
Education, Human Development and Social Sciences (ALTOONA)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027085
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Inclusion Criteria:
Able to stand and walk independently with or without the aid of an assistive device.
Male and female between the ages of 18 and 25.

Exclusion Criteria:
Involved in whole-body exercise (organized dance, Pilates, yoga, tai-chi, calisthenics), balance training, Wii training, or resistive exercise (free weightS, powerlifting, Olympic or strongman lifting, circuit training) in the previous 6 months.
Known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect ability to perform the testing procedures.
Use of a pacemaker.
Major general medical disorders, such as recent surgeries, implants in trained body parts (i.e., artificial joints), acute hernias, discopathies (i.e., slipped disks), rheumatoid arthritis, epilepsy, and/or acute thrombosis.
Using sedatives of any type upon enrollment to the study.
Men's Health, Sports Medicine, Women's Health
Not applicable
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Altoona, PA ,
State College, PA ,

Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults with Prediabetes

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease as a healthy Mediterranean diet without potatoes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

This study runs for about 3 months. During this time, you will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). We will provide you with all of the food you need to follow this diet. This will include 3 meals, snacks and some beverages prepared in the Penn State Research Kitchen, which will meet your energy and nutrient needs. During the study, we will ask you not to eat any foods outside of those provided by the study. You may have up to 5 days off the diet during the 12 week period. Testing will take place on two separate days at the beginning and end of the study (4 testing days total). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours. At these visits, we will collect a blood sample, measure your weight, and perform non-invasive tests to assess your vascular health. You will also be asked to wear a continuous glucose monitor (CGM) for 14 days—7 days before the first testing visit and 7 days at the end of the study. The CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. You will need to attend a visit to have the CGM fitted (2 visits total). Additionally, we will ask you to collect a stool sample twice during the study.

500

Yes
 

Kristina Petersen
DCHLab@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027785
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Inclusion Criteria:
Age 25-65 years
BMI 25-40 kg/m2

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
Alcohol intake > 14 drinks/week
Food & Nutrition, Heart & Vascular, Diabetes & Hormones
Not applicable
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State College, PA ,

Mechanisms of Action: The Impact of Emotional Well-Being Intervention in Increasing Optimism and Biological Markers

This study aims to support midlife adults by enhancing their emotional well-being and reducing psychological stress, which may affect cardiometabolic health. We are evaluating a novel 4-week program that integrates three components—emotional well-being–enhancing writing, chair-assisted squats, and slow-paced breathing—using a factorial design. Eighty adults aged 40–65 with a sedentary lifestyle will be randomly assigned to one of eight groups that include different combinations of these activities. Participants will engage in their assigned activities via Zoom five times per week over four weeks. Emotional well-being and stress will be assessed through self-report at multiple time points, and physiological health (e.g., blood pressure, heart rate, heart rate variability, inflammation) will be measured during in-person visits before and after the program. The study will also evaluate the feasibility, acceptability, and preliminary effects of each intervention component and their combinations.

Participants will engage in a four-week program involving three components: EWB-enhancing writing exercises, chair assisted squat, and slow-paced breathing. They will complete these activities five times per week, with each session lasting 30 minutes.Participants will undergo cardiovascular assessments at Penn State University’s Biobehavioral Health (BBH) Building at baseline and post-intervention. These assessments will include heart rate variability measured via a standard three-lead electrocardiogram (ECG) and continuous blood pressure measured non-invasively using a finger cuff device that captures beat-to-beat waveforms.

$300

Yes
 

Harold Lee
Rui Wang - at rmw6108@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026780
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Inclusion Criteria:
Age 40-65 years
Sedentary lifestyle
Able to engage in chair assisted squat
Willingness to participate in all study components
Ability to provide informed consent

Exclusion Criteria:
Age outside 40–65 years – individuals younger than 40 or older than 65 will be excluded
Physical limitations preventing chair assisted squat
Lack of technology or access – no computer/laptop and stable internet for Zoom and Qualtrics participation.
Inability to provide informed consent
Significant medical conditions that could be exacerbated by the intervention (e.g., severe cardiovascular disease)
Heart & Vascular, Prevention, Mental & Behavioral Health
Survey(s)
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State College, PA ,

PSCI# 25-001 TITLE PAGE A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

This study is comparing using rilvegostomig or pembrolizumab with a platinum based chemotherapy. The doctor, subject and study team will not know if the subject is receiving rilvegostomig or pembrolizumab.

After signing consent to agree to join the study, the subject will have lab work and scans of their body to see if they are wll enough to participate. If they begin study treatment, they must come to all study visits. It is important that the subject tell the study team if there has been a change in their medications and how they are feeling. Subjects will continue treatment until the treatment no longer is working, they no longer want to participate of the study doctor feels it is not safe for them to participate any further. Once study treatment is finished, subjects will be followed to see how they are feeling and what new treatments for their cancer they are getting.

$75.00 for each visit completed for a minimum of $300. Compensation may be more if additional visits are completed.

Yes
 

Takefumi Komiya
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06692738
STUDY00027369
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Inclusion Criteria:
Participant must be ≥ 18
Histologically or cytologically documented squamous NSCLC
Minimum life expectancy of 12 weeks
Minimum body weight of 30 kg.

Exclusion Criteria:
Severe or uncontrolled systemic diseases
History of organ transplant
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Activate: A Study of Engaged Teaching Methods across college courses

The IRB proposal is to conduct research to enhance effectiveness of teaching and learning in college.

Consent for Exempt Research The Pennsylvania State University Title of Project: A Study of Effective Teaching Methods across College Courses Principal Investigator: Yi-An Burleson, Ph.D. Email: ylb5007@psu.edu You are invited to volunteer to participate in a research study. This summary explains information about this research. The study is to collect data to know ways to improve college teaching and learning. Participants will fill out online surveys in teaching and learning in addition to demographic information (e.g. gender, ethnicity, year of study, etc.). It may take 40-50 minutes to complete all of the questions in the surveys. You are strongly encouraged to take the surveys at the beginning of a semester/quarter/term and then at the end of a semester/quarter/term. You are welcome to take the surveys in more than one semester/quarter/term but no more than twice per semester/quarter/term. There may be mild discomfort in feelings, but no risk beyond mild discomfort is involved in the study. If you feel distressed after taking the surveys, you are encouraged to seek counseling resources at college counseling centers. A list of counseling resources is available on request. Other than your email, no other identifying information will be collected. All of the information you provided will be kept confidential by storing it on password protected devices and two-factor authenticated (2FA) online Drive. You can get access through the Sona system/Study Finder of Penn State University. If you are a student at Pennsylvania State University, you can earn 3 points per course by sending an email to indicate that you in the study (with the name of the study), signing up on the Sona system, and indicate that you consent to participate by, clicking “Yes, I consent to participate. My responses to the following questions indicate that I agree to participate” on top of the Google Form at https://forms.gle/H3p2SnErkhpWmYYm7 and then fill out the online surveys at the end of the consent form. You can fill out the survey in the beginning and end of the semester for multiple semesters. If you have questions, complaints, or concerns about the research, you should contact Yi-An Burleson, Ph.D. at ylb5007@psu.edu. If you have questions regarding your rights as a research subject or concerns regarding your privacy, you may contact the Human Research Protection Program at 814-865-1775. Your participation is voluntary and you may decide to stop at any time. You do not have to answer any questions that you do not want to answer.

No
 

Yi-An Burleson
Yi-An Burleson - at ylb5007@psu.edu
Social Sciences and Education (BEAVER)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00021216
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Inclusion Criteria:
Adults (age 18 and above)
Students enrolled in a 4-year university
can read and understand English

Exclusion Criteria:
Participants who are not enrolled in any 4-year university
Participants who are under age 18
Participants who cannot read English
Prevention, Education
Survey(s)
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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH)

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH. The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 400 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.

You will be required to visit the study clinic at specific times points. Laboratory and safety assessments will be completed at each visit. You will need to take the study drug as directed. Study procedures that will be performed include Liver Imaging scans, Liver Stiffness Exams, Electrocardiogram, Bloodwork, Liver Biopsy and an Endoscopy.

Yes
 

Karen Krok
Wes Heinle - at jheinle@pennstatehealth.psu.edu
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06528314
STUDY00026213
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Inclusion Criteria:
Age 18-80
Previous history or presence of type 2 diabetes
Body mass index (BMI) ≥ 25.0 kg/m2

Exclusion Criteria:
Type 1 diabetes
Poorly controlled high blood pressure
Any current or prior history of decompensated liver disease
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate The Safety a Efficacy of Cretostimogene Grenadenorepvec In Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

The purpose of this Phase 2 clinical trial is to study treating patients with non-muscle invasive bladder cancer (NMIBC) with an investigational drug, Cretostimogene and DDM. Participants will be assigned to either Cohort A or Cohort B depending on whether they have previously been treated with BCG (Bacillus Calmette-Guerin) for NMIBC.

Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. For the first 2 years after treatment initiation, participants will be assessed for disease status every 3 months by urine cytology and cystoscopy, with directed TURBT/biopsy (if indicated). CT urogram or MRU will be performed every 6 months. Thereafter, efficacy assessments will be performed at 6-month intervals for up to an additional 2 years

Yes
 

Jay Raman
urologyresearch@pennstatehealth.psu.edu
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06567743
STUDY00027108
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Inclusion Criteria:
Bladder Cancer

Exclusion Criteria:
<18 years old
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Enhancing Domestic Violence Policies Through the Lens of Public Administration

This dissertation will look at the implementation process of current DV policies/strategies and how the process can be improved in Pennsylvania. The proposal will incorporate the voices of DV survivors and understand their experience with DV services. The goal of the study is to recommend ways to enhance the support structures available to survivors and victims.

Participants will be asked to take part in a one-on-one interview over PSU PSU-licensed Zoom video or audio. The interview will last about 45 to 60 minutes. They will be asked about your experiences with services, any challenges you faced, and your thoughts on what could improve.

20

No
 

Aishwarya Sinha
Aishwarya Sinha - at aks6765@psu.edu or 732-704-8318
Division of Undergraduate Studies (HARRISBURG)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027929
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Inclusion Criteria:
Must be 18 years of age or older.
Must be survivors of domestic violence who have interacted with DV services or the legal system in Pennsylvania within the last five years.
Must be able to provide informed consent
Must no longer be in immediate crisis and have already exited dangerous or abusive situations.
Must know how to speak English.

Exclusion Criteria:
Unable to provide informed consent.
Currently in an abusive situation
Less than 18 years of age
Not a victim or never used any of the domestic violence services in Pennsylavnia.
Cannto speak or understand English.
Prevention
Not applicable
I'm interested
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PIANO: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease

The study will investigate the role of standard medications for IBD on pregnancy outcomes. The subjects will be pregnant IBD patients receiving standard therapies. This study will also test whether the IBD medication transferred across placenta predicts the risk of infection. As many women receive these drugs during their reproductive years this information will guide future therapies for women with IBD and their children.

The participants will sign the informed consent. They will complete the questionnaires. There are four to five in the first year of pregnancy. After that, the questionnaires are annual, up to eighteen years after the birth of the child. The participants will have a blood sample done in the second trimester. They will send the sample to the sponsor.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027468
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Inclusion Criteria:
Adult, >18 years of age
Pregnant
Diagnosed with IBD-Crohn's disease
Receiving active treatment for IBD

Exclusion Criteria:
Less than 18 years of age
Not pregnant
Not able to complete the questionnaires
Digestive Systems & Liver Disease
Survey(s)
I'm interested
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Hershey, PA ,

Validation of Biomechanics Technology in Golf

The purpose of this study is to compare accuracy and repeatability of biomechanical metrics between technologies during golf swings. This study also aims to identify differences in swing characteristics between various skill levels and environments.

You will be screened with a Health History Questionnaire via email, online survey, or in-person. You will come to either the Suzy and Jim Broadhurst Golf Teaching and Research Center (GTRC) or the Penn State Golf Courses with your golf clubs to provide consent, collect blood pressure and heart rate, answer golf-related questions, and perform golf-related tasks (full swing shots with various clubs). Various technologies will be used to measure the biomechanics of your swing. The total time of participation is expected to be about 60-90 minutes.

When you have finished the golf-related activites, you will be provided with a brief piece of instruction from one of the Center’s two Class-A PGA Professionals.

Yes
 

Joe Lesueur
Joe LeSueur - at jvl7292@psu.edu or 814-867-3198
Recreation, Park and Tourism Management (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027952
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Inclusion Criteria:
Currently plays golf
18-55 years old
Physically capable of playing a full round of golf (18 holes)
A known or estimated handicap less than 35 and/or average score less than 120
Healthy and active (> 75 minutes of moderate exercise weekly)

Exclusion Criteria:
Major symptoms or known cardiovascular, pulmonary or metabolic disease
2 or more cardiovascular risk factors according to the Health History Questionnaire
A musculoskeletal injury within the past 3 months
Experiencing pain during a golf swing
Sports Medicine
Not applicable
I'm interested
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State College, PA ,

Assessing the Human Alignment of Counterfactual Evaluation Metrics in Recourse Generation

This study aims to understand how well current methods for evaluating Counterfactual recourse recommendations match human preferences. Participants will review different Machine learning model generated Counterfactual options and provide feedback on which options they find more practical and feasible. The goal is to improve Counterfactual generation systems so that they can offer recommendations that better align with what people actually want or need.

The participants will attend two Zoom sessions. During each session, they will compare loan profile options and indicate their preferences and acceptable change limits. A researcher will record their responses in the survey form. Each session will last approximately 30–45 minutes. Participants will receive $10 for completing the first session and $15 for completing the second session.

25

No
 

Amulya Yadav
Firdaus Choudhury - at Firdaus@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026097
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Inclusion Criteria:
18 years of age or older
able to communicate in English
have access to a device with Zoom capability
willing to attend two 30–45 minute Zoom sessions

Exclusion Criteria:
Under 18 years of age
cannot provide informed consent
without access to the internet or Zoom
Education
Survey(s)
I'm interested
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Driver Situation Awareness in Automated Driving Systems

This research is being done to investigate the effect of human-machine interface design on promoting driver situation awareness restoration and effective human-AI collaboration under varied takeover situations.

You will complete a set of questionnaires and evaluate the design of the automated driving system by driving on a driving simulator. During the drive, you will be asked to drive in automated mode and focus on tasks unrelated to driving until the system issues a takeover request. The form of the takeover request will change in the experiment. You will be wearing eye tracking glasses while performing the driving task. After the driving tasks, you will complete questionnaires about your perception of the system.

$10/hour

Yes
 

Yiqi Zhang
Yiqi Zhang - at yuz450@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028110
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Inclusion Criteria:
Having a valid driving license for at least two years
Fluent in English
Age 18 or older
Normal vision or vision that is corrected with contact lenses

Exclusion Criteria:
Anyone who only wears glasses to correct their vision
Education, Mental & Behavioral Health
Not applicable
I'm interested
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Study Locations

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State College, PA ,

Ready Set Recharge! Pilot Study

The objective of this study is to pilot test a text-message and electronic delivered educational intervention, Ready, Set Recharge focused on the mental health benefits of physical activity ( PA) in undergraduate students at Penn State University.

Participants interested in participating in this study will be directed to complete a pre-program survey that will take less than 30 minutes to complete. After completion of the survey, participants will be enrolled in the program which is 8 weeks in duration. The program is entirely online and participants will be sent weekly text messages with links to content to read about physical activity and mental health. Participants will also be taught strategies they can try to increase their physical activity behavior in their own life. Participants will compete weekly surveys that take less than 5 minutes to complete. At the end of the 8-weeks, participants will complete a post-program survey that will take less than 30 minutes to complete.

$25

No
 

Erica Rauff
Erica Rauff - at recharge@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026868
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Inclusion Criteria:
Undergraduate student at Penn State
Can read and understand English
18 years of age or older

Exclusion Criteria:
Not a current undergraduate student at Penn State
Unable to read or understand English
Under the age of 18
Mental & Behavioral Health
Not applicable
I'm interested
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PSCI 23-130 RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

This trial is looking at the progression free survival and overall survival in patients treated with docetaxel alone and those treated with docetaxel and RAS G12X-C

This study has 4 periods: 1. Pre-screening period (to provide your tumor genetic information) 2. Screening period (before you begin the study to see if you qualify for the study). This is when you will have all the testing done to make sure it is safe for you to join the study. it may require several trips to the hospital. 3. Study Treatment period (when you will receive the study treatment; this occurs in 21-day cycles). this is when you will be taking the study medication. For the first cycle of treatment you will need to come to the clinic about 3 times to make sure you are ok while taking the study drug. From cycle 2 onward you will need to come to the clinic twice. 4. Follow-up period (to check on you after your study treatment is finished) and then we will check to see how you are doing every three months. It is important that you come to all of your visits.

Yes
 

Patrick Ma
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06881784
STUDY00026897
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Inclusion Criteria:
Age: ≥ 18 years
Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Evidence of progressive disease (PD)

Exclusion Criteria:
Radiation therapy ended ≥2 weeks before randomization
Chemotherapy and Antibody Therapy; ≥3 weeks of randomization
Symptomatic congestive heart failure
Cancer
Experimental drug compared to an approved drug
I'm interested
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Hershey, PA ,

The effect of input conditions on language learning: The roles of salience, modality and context.

The present study will examine the role of different input conditions on the learning of words and morphosyntactic units in a new language. We specifically aim to examine the effects of variables researched in the field: type of knowledge (explicitly stated via pre-training, or incidental; Pellicer-Sánchez et al., 2021), salience (manipulated via input properties; Ellis &amp; Sagarra, 2010) and modality (visual or auditory; Borro, 2021) play on learning outcomes. Our goal is to examine how cognitive processes underlying learning are affected by our manipulations, and the impact on learning outcomes. We hypothesize that pre-training will enhance speakers' ability to detect target vocabulary and structures to be learned. While the literature is mixed on the role of salience, across the experiments described below, we will explore the impact of low-level salience (e.g., text enhanced visually) and psychological salience (the amount of repetition / expectedness of a target items. We will also investigate the less investigated effect of modality.

This is a language learning study. There will be up to two visits to the research lab. Sessions will consist of simple tasks consisting of readings sentences, remembering words, and completing memory tasks. EEG data will be collected via a wearable EEG cap; eye-tracking data will be collected while reading and completing some of the tasks are on a computer.

18 / hour

Yes
 

Manuel Pulido
Manuel Pulido - at mpulido@psu.edu
Spanish, Italian and Portuguese (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027420
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Inclusion Criteria:
Must speak English proficiently
Must be between 18 and 45 years old.
Right handed
Normal or corrected-to-normal vision
No history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)

Exclusion Criteria:
Ages younger than 18 or older than 45 years old.
Speakers with low English proficiency.
Left-handed or ambidextrous
Uncorrected vision
A history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)
Education, Neurology, Language & Linguistics
Not applicable
I'm interested
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State College, PA ,

A Phase 1 Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants with Hemophilia A or Hemophilia B (Part B)

SR604 is a monoclonal antibody that blocks anticoagulant activity, which improves clotting in patients with the clotting disorders of Hemophilia A &amp; B. This study is looking at treatment options for Hemophilia A &amp; B. There will be 4 cohorts (1B, 2B, 3B &amp; 4B). Our site will be starting study drug SR604 dose escalation with 0.1mg/kg (2B), then 0.2mg/kg (3B) with the final dose 0.4mg/kg (4B). Lower doses will start in the first cohort &amp; dose escalation will continue in subsequent cohorts after a 3-month monitoring period in each cohort. See page 44 of the protocol for patient numbers in each cohort.

Participants will receive subcutaneous SR604 every 4 weeks for 3 months. Total visits to site will be 15. Blood draws will be obtained at each of these 15 visits.

75.00 per visit travel reimbursement

Yes
 

M. Elaine Eyster
Cynthia Campbell-Baird - at cbaird@pennstatehealth.psu.edu or 717-531-5777
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06349473
STUDY00026729
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Inclusion Criteria:
BMI 18-30 (>50 kg & < 90)
Severe congenital Hemophilia A
Severe and/or moderate congenital Hemophilia BA
Patients with inhibitors are permitted

Exclusion Criteria:
History of smoking/nicotene, alcohol abuse or illicit drugs within 1 year of screening
Hemophilia A pts. currently treated with hemlibra
Active infections requiring antibiotic/antiviral therapy
Blood Disorders
Not applicable
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Hershey, PA ,

Menopause Stage and Depression Symptomatology

This study aims to examine differences in physiological variables (inflammation and heart rate variability) at different menopausal stages and whether these differences influence depression symptomatology. There will be one 3.5-4 hour in person study visit that includes completion of questionnaires, cognitive tests, electrocardiogram (ECG) recordings, and one blood draw.

There will be one 3.5-4 hour in person study visit that includes completion of questionnaires, cognitive tests, electrocardiogram (ECG) recordings, and one blood draw. If you are still having menstrual periods, you will be asked to record menstrual bleeding on a menstrual calendar for 3 cycles.

75

Yes
 

Molly Wright
Molly Wright - at mpw5810@psu.edu or 813-310-1889
Division of Graduate Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027757
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Inclusion Criteria:
40-55 years old
assigned female at birth
English fluent
less then 2 years past the final menstrual period if postmenopausal
if on antidepressants, on a stable dose for 8 weeks

Exclusion Criteria:
history of hysterectomy or oophorectomy
taking hormone medications in past 3 months
on strong anti-inflammatory medications
history of cardiovascular (other than hypertension) or neurological disease
Diagnosis of Bipolar or Psychotic Disorder
Mental & Behavioral Health, Women's Health
Not applicable
I'm interested
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State College, PA ,

Producing code-switched speech

Bilinguals frequently mix languages, even mid-sentence, when communicating with other bilinguals, a practice known as code-switching. This study aims to understand how bilinguals weave together different ways of producing the same sounds, corresponding to the languages they use, when code-switching. Participants will read aloud a list of sentences in Spanish, or in Spanish with switches to English partway through. They will also complete English and Spanish proficiency tasks and a questionnaire about their language background.

Participants will participate in a single session in our lab, lasting about an hour. During this time participants will: Produce words and sentences in Spanish and English. These will be audio recorded. Read and make decisions about words in Spanish and English. Name pictures in Spanish and English. These will be audio recorded. Complete a questionnaire about your language background.

$15

Yes
 

Matthew Carlson
Matthew Carlson - at mtc173@psu.edu
Spanish, Italian and Portuguese (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028114
Show full eligibility criteria
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Inclusion Criteria:
Bilingual speaker of Spanish and English
Speaker of Puerto Rican Spanish

Exclusion Criteria:
History of speech or language disorders
Language & Linguistics
Not applicable
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State College, PA ,

A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

The purpose of this study is to find out if an implant of ACT is safe and effective in reducing urinary incontinence. The study will involve about 132 women that have urinary incontinence. This system is investigational. After placement of the devices, participants will be followed for 12 months on a regular visit schedule. Annual visits may continue for up to 5 year. ACT® is an implantable device for treating stress urinary incontinence. One end of the device is a balloon that is attached by a tube to a port at the other end of the device.

Participants will attend a screening visit, the implantation visit, post-op assessment, 6 week, 3 month, 6 month, 12 month, and annual follow up visits for necessary device adjustments.

600

Yes
 

Susan MacDonald
Sneha Patel - at spatel42@pennstatehealth.psu.edu or 717-531-0003, ext=283173
Urology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT04248283
STUDY00023525
Show full eligibility criteria
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Inclusion Criteria:
Stress Urinary Incontinence with primary intrinsic sphincter deficiency
Failed at least 6 months of previous treatment for stress urinary incontinence

Exclusion Criteria:
Prior pelvic radiation
Currently undersoing radiation therapy
Pregnant/lactating women
Kidney & Urinary System, Women's Health
I'm interested
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Study Locations

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Location Contacts
Hershey, PA ,