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Validation of Cell-free mitochondrial DNA (cf-mtDNA) Saliva Collection Methods

The reproducibility, reliability, and validity of saliva collection techniques is an important issue that needs to be addressed to achieve consistency in the emerging field of mitochondrial psychobiology. The objective of the current study is to increase scientific rigor by utilizing robust and well-controlled methods in the collection and testing of saliva samples. Given the non-invasive and convenient nature of saliva collection, it is likely that research using saliva-derived cell-free mitochondrial DNA (cf-mtDNA) will increase. Therefore, to ensure that the results obtained from the current study are trustworthy and meaningful, we are proposing a small, highly controlled randomized study design that will integrate three methods of saliva collection. The study will adopt a rigorous and systematic approach to data collection, analysis, and interpretation. Through the implementation of these methods, we seek to achieve a higher degree of accuracy and reliability in cf-mtDNA saliva-based measurements.

Each participant will be asked to collect 3 randomized saliva samples (i.e., one static Salivette®, one active Salivette®, and either a second active Salivette® or a passive drool) upon awakening for 10 business days. All collection materials be pre-labeled with the day, type of sample, and order to make it easy for participants to quickly and accurately deposit samples upon awakening. Once saliva samples are collected, participants will be asked to promptly return the samples to the provided plastic bag and store the bag in their at-home freezers. All samples will be stored there until the end of the 10-day study. After the saliva is returned to the freezer, participants will complete a short (3-5 min) morning survey on the provided mobile device which has been pre-loaded with the M2C2 application. The morning survey asks questions about sleep, morning outlook, and anticipatory stress and positive experiences. In the evenings, participants will be prompted (via banner notification on screen and audible beep) to complete a slightly longer (8-10 min) survey. This survey asks questions about the respondent’s daily experiences (stressors, mood, physical symptoms). Within the application, there are three brief, objective cognitive tasks. Upon completion of the 10-day protocol, respondents will return the mobile device and saliva samples. Participants may bring all saliva samples back to the lab during regular business hours, or they may schedule a time for a member of the study team to pick up the samples. Depending on the distance between the laboratory and the participant’s home, the need for ice packs will be assessed on an individual basis.

50

Yes
 

Idan Shalev
Lauren Petri - at laurenpetri@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023371
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Inclusion Criteria:
healthy adult
between the age of 18-50 years
must be English speaking
cannot be pregnant or breastfeeding
must not use tobacco

Exclusion Criteria:
Younger than 18
Individuals who work nightshift
Individuals who do not have access to an at-home freezer
Individuals who have an irregular sleep-wake cycle
Individuals who currently use tobacco
Infectious Diseases & Immune System, Mental & Behavioral Health
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State College, PA ,

PSCI 22-082 Tropion-Breast03

This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.

Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05629585
SITE00001344
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Inclusion Criteria:
Participant must be ≥ 18 years at the time of screening.
Histologically confirmed invasive TNBC.
Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.14
No evidence of locoregional or distant relapse. Radiological scans before treatment are not required and should be obtained as per local institutional practice.

Exclusion Criteria:
Stage IV (metastatic) TNBC.
History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection,
History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

An Examination of Student-Mentor Relationships

This is a self-report survey and questionnaire study that examines whether members of marginalized groups are more motivated than members of dominant groups to give referent power to high status others in attempts to belonging.

No
 

Maria Sanchez
Maria Sanchez - at mfs5350@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007731
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Inclusion Criteria:
All Genders
All races/ethincities
Participants between 18 and 25

Exclusion Criteria:
Participants YOUNGER than 18
Participants OLDER than 25
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22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.

Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication

Yes
 

Seema Naik
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03215030
SITE00001303
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Inclusion Criteria:
MM defined by the IMWG criteria with evidence of disease progression and: a)Is in need of additional myeloma therapy as determined by the investigator.
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a)Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.

Exclusion Criteria:
Patient has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis,
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Minoritization and transnational social hierarchies: Caste and race in the Indian immigrant context

The study looks to understand how caste and race play out among Indian students, especially Indian immigrant students. Caste is the predominant social category in India. However, as Indian students migrate into to the USA, the social category of race is introduced and social category of caste is not understood outside of the Indian community. Through qualitative interviewing, it is aimed in this study to determine how migrating to the USA and becoming a minority and a person of color can potentially change how Indians view caste and caste identities in India. The primary hypothesis of the study is that the process of becoming becoming a minority through immigration can be used to think back on caste, and to think forward on race in both India and the USA.

No
 

Ashwin Mohan
Ashwin Mohan - at akm73@psu.edu or 518-992-8324
Curriculum and Instruction (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017989
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Inclusion Criteria:
Adults 18 years old or above
Citizen/Resident of India for at least 5 years OR one or both parents have been citizens of India for at least 5 years
Students/Faculty members at Penn State

Exclusion Criteria:
Subjects who do not meet the inclusion criteria
Subjects who do not speak English
Education
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The effect of repetitive thinking on emotional reactivity to daily events in depression and generalized anxiety disorder: Application of the contrast avoidance model

This is an ecological momentary assessment study that will examine the relationship between daily events, emotion, and repetitive thinking using a mobile application. The participants will be required to answer 2 minutes questionnaire and monitor their heart rate 8 times a day for 8 consecutive days.

If you are eligible based on the screening survey, there will be one Zoom study session where you will complete a brief videotaped clinical interview to further determine your eligibility to participate in the study. If you are eligible and decide to continue in the study, you will complete a brief questionnaire and be trained on how to complete the study. Starting the next day, you will complete eight 2-minutes questionnaires per day and monitor your heart rate using smartphone application for 8 days.

Up to $20 (Amazon gift card)

Yes
 

Seung Baik
Seung Yeon Baik - at sbb5887@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017148
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Inclusion Criteria:
Adults aged 18 years and above.
Owns iPhone.
Scores high or low on depression and anxiety symptoms measure
Fluent in the English language in terms of speaking, listening, reading, and writing

Exclusion Criteria:
Alcohol or substance abuse occurring within 6 months
Meets diagnostic criteria for bipolar disorder or schizophrenia-related disorders
Has suicidal thoughts
Unable to speak, read, listen, and write English fluently.
Mental & Behavioral Health
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State College, PA ,

“Quiet Quitting and the Great Resignation: Investigating Work Devotion, Ideal Worker Norms, and Job Quality in the Wake of the 2020 Pandemic”

This proposal seeks to investigate the changes in the workforce in the wake of the 2020 pandemic. While worker shortages were hot topics following the pandemic recovery, the broad trends defining United States labor force are clear: labor force participation has been declining for decades. By examining the relationship between American worker’s work devotions, their occupational characteristics, and their labor market attachment, this project will highlight the organizational and policy contexts that shape continued labor market participation while also bringing to light those policies that may weaken labor force attachment.

1. Participants will be asked to participate in a two and a half hour long open-ended interview. 2.The interviews will be conducted in person whenever possible and will be recorded and transcribed. The participant will choose the location of the interview and if they do not have a possible private space, the interviewer will offer to take for coffee or to interview on campus. If necessary, interviews can also be conducted via the phone or via zoom.3.Once the consent form has been signed, during the 2 &½ hour interview, the respondents will be asked to answer questions about family history, educational background, work history, current work circumstances, their experiences of work during the Covid-19 pandemic; impressions of how their work environments has/has not changed; poverty, partnerships, child-bearing, work-family conflict, future plans, and opinions. 4.The interviews will be taped and transcribed. 5.Participants may choose to skip any questions that they would prefer not to answer.6. Participants will be asked if they consent to be contacted again in 6-12 months to see if their work circumstances have changed and to ask any follow up questions that may have arisen since the start of the study.

100

Yes
 

Sarah Damaske
Sarah Damaske - at sarahdamaske@psu.edu or 718-473-7358
Labor and Employment Relations (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00022980
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Inclusion Criteria:
1.Participants must be between the ages of 25-55 (prime working years)
2.Participants must have worked in the prior year

Exclusion Criteria:
They are under the age of 18
They will also be excluded if they are not English speaking
They may not be under the age of 25 or over the age of 55 (prime working years)
They did not participate in at least one hour of paid labor in the past year
Men's Health, Education, Women's Health
Not applicable
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Altoona, PA ,
Carlisle, PA ,
DuBois, PA ,
Erie, PA ,
Greater Philadelphia Area, PA ,
Greater Pittsburgh Area, PA ,
Harrisburg, PA ,
Hazleton, PA ,
Hershey, PA ,
Mont Alto, PA ,
Reading, PA ,
Schuylkill Haven, PA ,
Sharon, PA ,
State College, PA ,
Wilkes-Barre/Scranton Area, PA ,
Williamsport, PA ,
York, PA ,

PACE – Development of an Eating Behavior Risk Score

The prevention of obesity is a far more effective approach than treating obesity after it has developed. Researchers and medical providers need better tools to identify risk factors for developing obesity, so families and their physicians can work to reduce a child's risk. This proposed study tests whether a novel risk score (PACE) is good at predicting if children will develop obesity. The PACE Score combines the measures of sensitivity to portion size, behavior while hungry or craving, loss of control during eating, and eating speed. This study will follow children in middle childhood through four visits, followed by two visits one year later. We will identify the components of PACE as well as biological and environmental factors that may work with or against the PACE factors to predict how children's body composition changes over a year.

Four baseline visits followed by two follow-up visits one year laterChildren will be provided meals at each visitChildren and parents will complete questionnairesChildren will have a DXA scan and an MRI scanChildren will play learning games on the computerChildren will wear an activity monitor for one weekChildren will perform brief and moderate exercise while wearing a heart rate monitor

$300

Yes
 

Kathleen Keller
Ben Baney - at bab349@psu.edu or 814-883-8523
Nutritional Sciences (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT05073185
STUDY00023903
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Inclusion Criteria:
children must be between the ages of 7-9 years-old at enrollment
The biological mother must have a BMI between 18.5 – 25 or greater than 30. The parent primarily in charge of feeding must be able to accompany children to the visits.
children must speak English fluently
children should have no learning disabilities or developmental delays (e.g., ADHD, Autism, dyslexia)
children generally healthy with a BMI-for-age percentile less than 85 or greater than 95 to be enrolled.

Exclusion Criteria:
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
Child medical condition affecting digestion, cardio, etc.
Child not fluent in English
Child should not be taking a medication that affects blood flow, appetite, behavior, etc.
Child should not have any unremovable metal in their body (e.g. steel dental work) or be claustrophobic
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,

A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)

This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.

If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.

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
NCT04317534
STUDY00015618
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Inclusion Criteria:
Males and females age ≥ 18 years.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization

Exclusion Criteria:
Patients with tumors that are known to harbor actionable EGFR mutations are NOT eligible.
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Cancer
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Hershey, PA ,

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F1 Fibrosis

The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis by shutting down the production of Z-AAT. Decreasing Z-AAT build up in liver cells is important, as this protein has been clearly identified as the cause of liver injury in AATD.In this study, fazirsiran is being compared with a placebo for patients with AATD LD. A placebo is a liquid like fazirsiran but does not contain any active ingredients.

You will visit the study site approximately 12 times for blood sampling, computed tomography (CT) lung densitometry, lung function tests, FibroScans, ultrasounds, liver biopsy, esophagogastroduodenoscopy (EGD) study drug administration, and questionnaire completion.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06165341
STUDY00024618
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Inclusion Criteria:
The participant, of any sex, is aged 18 to 75 years, inclusive.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has evidence of METAVIR stage F1 liver fibrosis
An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kg/m2, inclusive.
The participant is a nonsmoker

Exclusion Criteria:
The participant has evidence of ≥ F2 fibrosis based on liver biopsy during the screening period.
The participant has a history of varices based on a previous esophagogastroduodenoscopy.
The participant has portal vein thrombosis.
The participant has HIV infection as shown by the presence of anti-HIV antibody (seropositive).
The participant is pregnant or breastfeeding or intending to become pregnant before participating in this study, during the study.
Infectious Diseases & Immune System, Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Couples' Daily Lives with Chronic Back Pain

The purpose of this study is to learn more about the daily experiences of people with back pain and their spouse/partner. Participants and their spouse/partner will be interviewed by video using a tablet computer every 6 months for 2 years and will be asked to complete daily surveys twice a day for 30 days using the provided tablet computer. The daily surveys will take about 5 to 10 minutes to complete. Questions for the interviews and daily surveys focus on physical symptoms, feelings, activities, and interactions.

Video interviews using a tablet computer every 6 months for 2 years. Complete daily surveys twice a day for 30 days using a tablet computer.

295.00

No
 

Lynn Martire
Kari Whitehead - at couplesstudy@psu.edu or 814-865-7094
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013726
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Inclusion Criteria:
Individuals with back pain at least 65 years or older
Experienced moderate or severe back pain for at least 3 months
Married or in a long-term relationship AND living with spouse or partner

Exclusion Criteria:
Does not work more than 20 hours a week outside the home
Arthritis & Rheumatic Diseases, Pain Management
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Remote testing for psychophysical studies of sensory perception and cognition

The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia.

Participants will complete simple online tasks, for example judging differences in auditory pitch; processing visual and auditory stimuli in congruent and incongruent pairings; rating the sound-symbolic properties of either real words, pseudowords, or both; or discriminating between two stimuli on the basis of their structural properties over a change in their surface properties, and vice versa.

Amount varies depending on the study

No
 

Krishnankutty Sathian
Simon Lacey - at sathianlab@pennstatehealth.psu.edu
Neuroscience and Experimental Therapeutics (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015197
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Inclusion Criteria:
Healthy adults over 18 years old
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia

Exclusion Criteria:
Minors under the age of 18
Neurology, Language & Linguistics, Vision & Eyes
Not applicable
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Convergence of online machine learning policies for haptic feedback

The purpose of this study is to determine whether a machine-learning based algorithm for generating on-skin feedback can be trained quickly and can adapt quickly to changes in the environment. Participants will have an armband with vibration motors and microcontroller fitted to their right arm. They will provide indication about where around the circumference of their arm, they feel the vibration using a joystick. The joystick responses will be used to update a machine learning policy online such that the desired joystick responses match the actual ones by adjusting the levels of vibration in each motor.

There will be one in-person visit. You will have an armband with vibration motors and microcontroller fitted to your right arm. You will grasp a small joystick and move the stick around following the indications given by the vibration and/or visual display.

15

Yes
 

Katie Fitzsimons
Zachary Logan - at zal5@psu.edu
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026482
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Inclusion Criteria:
Able-bodied
Right-handed

Exclusion Criteria:
upper-limb injuries
neuromotor disorder
Not applicable
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State College, PA ,

PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)

This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.

Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.

Yes
 

Leonard Tuanquin
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05705401
STUDY00024714
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Inclusion Criteria:
The patient must be ≥ 40 years of age.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Pattern Learning in Human Adults

We are interested in what adults notice about stimuli that are presented to them. These stimuli typically consist of novel objects, abstract images, or made-up words.

Yes
 

Elisabeth Karuza
Elisabeth Karuza - at exk521@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010804
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Inclusion Criteria:
Age 18 and older
Fluent in English
Minimum High School Education
Normal or corrected-to-normal vision/ hearing

Exclusion Criteria:
No history of neurological injury or disorder
Those unable to consent, pregnant women, children, and prisoners will be excluded.
Language & Linguistics
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State College, PA ,

Defining the role of slow eye movements on limb motor control

The purpose of this study is to define how eye movements contribute to eye-hand coordination. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environment will attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball. Our objective is to understand how the nervous system processes visual sensory information of moving objects through slow eye movements called smooth pursuit eye movements.

During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Penn State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes.We will ask you to perform an eye-hand coordination task using a robot. You will sit in a modified chair and grasp a handle that permits you to move your hand leftward, rightward, towards and away from your body. A display system will project visual targets into the same plane as your hands, which will allow you to interact virtually with the visual targets. These targets will move in the workspace. When the target comes in contact with your arm, the robot will apply a gentle force to mimic what you would typically experience when you catch a ball.

40

Yes
 

Tarkeshwar Singh
Oindrila Sinha - at osinha@psu.edu or 814-206-6260
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023321
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Inclusion Criteria:
Participants should be between 18-65 years old.
Male and female participants who volunteer for the study and provide informed consent.
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.

Exclusion Criteria:
Any history of neurological disorders
Any history of musculoskeletal disorders.
Eye or vision problems.
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol.
Medication that could make the participant drowsy or tired during the experiment.
Neurology
Not applicable
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State College, PA ,

Understanding the user experience of using consumer-facing digital symptom checkers

This is an interview study that examines how people use online symptom checker platforms or apps (e.g., WebMD, Ada, K health app, Your.MD) to self-diagnose or support the decision of whether and when to do a medical visit. The research procedure involves: 1) a short screening survey which helps us determine who are eligible to participate; 2) an audio‐taped interview with each eligible participant that will last approximately 30‐60 minutes online or offline near Penn State University Park. Each participant will be compensated with a $20 Amazon gift card for completing the interview.

Yes
 

Xinning Gui
yxy340@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013312
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Inclusion Criteria:
Live in US
Speak English or Chinese
At least 18 years of age
Have used online symptom checker platforms or apps

Exclusion Criteria:
Less than 18 years old
Have never used any symptom checker
Vulnerable populations such as children, pregnant women, cognitively impaired adults, and prisoners
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Altoona, PA ,
Hershey, PA ,
State College, PA ,

PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER

The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.

Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.

Yes
 

Mitchell Machtay
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05540899
STUDY00022103
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1

Exclusion Criteria:
Recurrence of the study cancer.
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
Cancer
Not applicable
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Hershey, PA ,

Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) To Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

A study that looks at the efficacy of Frexalimab compared to standard of care drug, Teriflunomide, for adults with relapsing forms of MS.

The purpose of this clinical trial is to compare the efficacy and safety of investigational products in adult participants with relapsing forms of multiple sclerosis. There will be about 22 in person visits over 3.5 years that consist of monthly IV medication administration, monthly oral tablet medication dispensation, Magnetic resonance imaging (MRI) roughly every 6 months, monthly blood draws for lab work, vitals, ECG, and clinical outcome assessments. 13 of these visits are within the first 12 months of the study. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and the Clinical Research Center (CRC) in the main hospital.

Up to $4300

Yes
 

Jikku Zachariah
Kasey Schutt - at klong10@pennstatehealth.psu.edu or 717-531-0003, ext=289869
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06141473
STUDY00025586
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Inclusion Criteria:
18-55 years of age
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must agree to use contraception for both male and female participants.
Must be able to sign informed consent or have a legally authorized representative to sign.

Exclusion Criteria:
Diagnosis with primary progressive multiple sclerosis or with secondary progressive multiple sclerosis without activity.
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects, equal to or over 3 months of teriflunomide.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
Neurology
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Hershey, PA ,

PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.

Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.

Yes
 

Monika Joshi
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
NCT04628767
STUDY00023370
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Inclusion Criteria:
Patient must be ≥18 years of age.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding

Exclusion Criteria:
Patients must have no evidence of metastatic disease
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
Cancer
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Hershey, PA ,

Cognitive and Social Factors Underlying Spoken Language Use

The central purpose of this research is to understand how language users produce and comprehend speech. To do this we ask participants to record speech, make judgments on the speech they hear, and work with a partner on simple language tasks.

Yes
 

Navin Viswanathan
Navin Viswanathan - at splaco@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011708
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Inclusion Criteria:
English Speakers
Between 18 and 65 years of age

Exclusion Criteria:
Those with diagnosed speech, hearing or language Issues
Language & Linguistics
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State College, PA ,

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Repotrectinib for cancer that has returned or is not responding to treatment

If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04094610
STUDY00014715
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Inclusion Criteria:
You have cancer that has returned or is not respondin g to treatment
You are positive for certain changes in your genes which we will test you for as needed

Exclusion Criteria:
1. You have gastrointestinal disease, such as Crohn’s disease,
Cancer
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Hershey, PA ,

The naturalistic reinforcement of obsessions and compulsions: An ecological momentary assessment study

The purpose of this study is to examine the relationship between sleep patterns, thoughts, behaviors, and emotions in obsessive-compulsive disorder (OCD). In the screening visit, participants will complete a brief interview and questionnaire to determine if they are eligible to participate in our study. Eligible participants will complete additional questionnaires and a training session on study procedures. Following this visit, for the next 7 days, participants will complete daily questionnaires and (for those selected to be in the sleep monitoring group) monitor their sleep by wearing a sleep watch. On day 4, participants will attend a brief compliance check Zoom visit where they will be informed about their overall compliance rate. Participants will be compensated with course credit. Findings from this research may help improve understanding of OCD symptoms and sleep.

Screening Visit: This can be conducted in person or over Zoom. During this visit, we will administer a short questionnaire and an interview to determine if you are eligible to participate in the study. If you are eligible, you will complete questionnaires and a training session on study procedures. You will also receive a sleep watch, which you will be asked to wear consequently for 7 days. This visit will take approximately 1 hour and 25 minutes.7 Day Monitoring: For the next 7 days, you will complete several, brief daily questionnaires (7 questionnaires/per day) on your smartphone. Questionnaires will take place generally every 2 hours starting from 10 a.m. to 10 p.m. You will also monitor your sleep by wearing a sleep watch and maintaining a daily sleep diary.Compliance Check (Day 4): On day 4, there will be a 5 minute compliance check Zoom meeting where you will be informed about your overall study compliance rate. Return and Debrief: At the end of the 7 days, you will be asked to return the sleep watch to our lab location (Moore Building) or schedule a pick-up time with a study team member. You will also receive an educational debriefing handout over email.

No
 

Valerie Swisher
Valerie Swisher - at vss5199@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024470
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Inclusion Criteria:
Meets criteria for Obsessive-Compulsive Disorder
Owns an iPhone or Android Smartphone
Fluency in English
Age 18 or older

Exclusion Criteria:
Younger than 18
Not able to consent or commit to study duration
Does not meet criteria for Obsessive-Compulsive Disorder
Meets criteria for certain conditions (e.g., schizophrenia)
Not fluent in English
Sleep Management, Mental & Behavioral Health
Not applicable
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Gaming Communities as Virtual Third Places: A Quantitative Assessment

This study will collect information about the use of gaming communities for social interaction.

Participants will be asked to complete a short survey.

No
 

Jeffrey Stone
Jeffrey Stone - at stonej@psu.edu or 610-285-5003
Information Sciences and Technology (LEHIGH VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021668
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Inclusion Criteria:
Adults 18 years of age and older.

Exclusion Criteria:
Individuals under 18 years of age.
Mental & Behavioral Health
Not applicable
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One Talk at a Time - Anti-Racism

This is a psychological study to examine the effect of a new intervention that provides parents with tools to speak with their kids about race, racism, and privilege.Participants will complete a 2-3 hour long program and answer questionnaires over the course of 6-8 weeks. The total time required for this study is approximately 4.5 hours for parents and 2 hours for children. Parents can earn up to $165 and children can earn up to $50.

Parents and children will both be asked to participate, and all participation will be remote.Over the course of 6-8 weeks, parents will answer 3 sets of questionnaires in addition to completing 2-3 hour long interactive program. Parents will also be asked to participate in a recorded discussion task with their child, and will be invited back for a short interview as the final task.Children will answer 2 sets of questionnaires at the beginning and end of the study, and will also participate in the recorded discussion task with their parents.

215

No
 

Chardee Galan
Chardee Galan - at dreamlab@psu.edu or 626-205-5563
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00023214
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Inclusion Criteria:
Non-Hispanic, White parent and child
Child between the ages of 10-14 years old
Child in 5th through 8th grade
Parent and youth are fluent in English
Parent and youth have access to devices with WiFi

Exclusion Criteria:
Parent or youth identify as any race/ethnicity other than non-Hispanic White, including multiracial individuals that identify as White
Family does not have reliable internet access or access to a device that can appropriately display the virtual program.
Parent or children does not speak or read sufficient English
Youth or parent/caregiver has an intellectual disability, autism spectrum disorder, or other disorder that may limit ability to complete study (surveys and interviews require sustained attention, mental processing, and comprehension)
Children's Health, Education, Mental & Behavioral Health
Not applicable
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Effects of increased interstitial pressure on venous distension reflex

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

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

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

Yes
 

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

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

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

A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function (BalanceD-HF, D6402C00012))

The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization

Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.

up to $1,600

Yes
 

Umar Farooq
PSHVIResearchCoordinators@pennstatehealth.psu.edu 717-531-5967
Medicine: Nephrology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06307652
STUDY00024754
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Inclusion Criteria:
recent heart failure event
being treated for heart failure
undergoing treatment for decreased kidney function

Exclusion Criteria:
chest discomfort, heart attack or stroke within last 3 months
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease
Kidney & Urinary System, Heart & Vascular
Experimental drug compared to an approved drug
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Hershey, PA ,

Student Housing Assessment

The primary objectives are to identify why students choose where they live; what is their perception of value for housing; is this value based on their home city/state/country; how are they paying for housing costs; if their parents are paying for the housing, what perception of value do the parents have, what is their economic status, what is their home owning status, etc.

No
 

Mallory Meehan
Mallory Meehan - at mmm446@psu.edu
Institute for Real Estate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010798
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Inclusion Criteria:
Undergraduate Student
Graduate Student
Enrolled and living at University Park

Exclusion Criteria:
Non-student
Education
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Expanding Family Foundations to 2nd-Time Parenthood - Focus Group

This focus group study, funded by Penn State's Social Science Research Institute, brings together couples with preschool-aged firstborns who are pregnant with their 2nd child or who have given birth to their 2nd child within the last 12 months. Couples will be interviewed about how they worked together as a team (as coparents) to prepare their firstborn for the birth of the second child and to prepare themselves for 2nd-time parenthood.

Yes
 

Douglas Teti
Douglas Teti - at dmt16@psu.edu or 814-863-9570
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015968
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Inclusion Criteria:
1.Two-caregiver families, any race or ethnicity, with one or two children: a.One subgroup with one child < 6 years of age and pregnant with a 2nd child b.One subgroup with one child < 6 years of age and an infant between 1-to-12 months of age.
2.Each caregiver is over 18 years of age.
3.Caregivers are living together in the same household and are either married or living with a partner.
4.Families living independent of parents’ families of origin.
5.Both caregivers fluent in communicating in English.

Exclusion Criteria:
1.One or the other caregiver cannot understand or speak English
2.Caregivers are under 18 years of age.
3.Caregivers not living together
4.Caregivers not living independently of their families of origin
5.Single-parent families with no live-in partner.
Children's Health, Prevention, Mental & Behavioral Health
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Study Locations

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Altoona, PA ,
Carlisle, PA ,
DuBois, PA ,
Erie, PA ,
Greater Philadelphia Area, PA ,
Greater Pittsburgh Area, PA ,
Harrisburg, PA ,
Hazleton, PA ,
Hershey, PA ,
Mont Alto, PA ,
Reading, PA ,
Schuylkill Haven, PA ,
Sharon, PA ,
State College, PA ,
Wilkes-Barre/Scranton Area, PA ,
Williamsport, PA ,
York, PA ,

A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema

This study will investigate the effects of NTLA-2002 on people with Hereditary Angioedema (HAE). NTLA-2002, which consists of a CRISPR/Cas9 gene editing system, is designed to limit production of plasma kallikrein in the liver cells by acting on the KLKB1 gene. This means NTLA-2002 would permanently change the DNA in the liver cells so less plasma kallikrein would be produced. Lower levels of plasma kallikrein may result in fewer HAE attacks.

During part 1 of the study, participants will either be given NTLA-2002 or placebo (no active ingredients) as an intravenous infusion. Participants will have the option to receive the opposite infusion about 28 weeks later. This study involves getting pre-medications to reduce the chance of an HAE attack and a reaction to the infusion. Study assessments will be preformed to monitor safety. Daily electronic diaries will be completed to monitor for HAE attacks. Also quality of life questionnaires will be completed. If part 1 and part 2 are completed, there are 22 visits. Some of those visits can occur over the phone.

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06634420
STUDY00025612
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Inclusion Criteria:
Males or females 16 years of age or older and Ability to understand and the willingness to sign a written informed consent document
Diagnosis of Hereditary Angioedema Type 1 or Type 2
Access to rescue treatment for Hereditary Angioedema

Exclusion Criteria:
Liver cirrhosis
history of drug or alcohol abuse in the past 3 years
history of active cancer in the past 3 years
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,