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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (MRT849-001)

This study is to determine the maximum tolerated dose (MTD) of MRTX849 using one or more dosing regimens. The regimens includ using MRTX849 or in combination with Afatinib, Cetuximab, or Pembrolizumab. The study will also look at how it can be tolerated MRTX849 when its taken with food.

If you take part in this research, your major responsibilities will include: •Keep your study appointments and complete all study assessments. If you cannot keep anappointment, please contact study personnel (your study doctor or study staff) as soon aspossible to schedule a new appointment.•Inform your study personnel about any symptoms, changes in medications, doctor's or nurse'sappointments, or hospital admissions that you may have had.•Agree to not participate in any other clinical research study•Inform study personnel if you believe you or your partner might be pregnant•Inform study personnel if you change your mind about participating in the study.•Inform your other doctors that you are taking part in this study.•Avoid grapefruit and grapefruit juice.•Avoid herbal medications and preparations including but not limited to St. John’s wort, Kava,turmeric/curcumin, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA),yohimbe (yohimbine), saw palmetto, and ginseng.•Avoid medications that are processed by liver enzymes, your doctor will counsel you on these.•Avoid medications known to have risk of changing the electrical activity in the heart, your doctorwill council you on these.•For your safety, you must tell the study doctor or nurse about all the prescription drugs, herbalproducts, over-the-counter drugs (OTC), vitamins and other supplements you are taking.Check with the study doctor before starting any new medicines (including prescription, OTCdrugs, vitamins and herbal supplements) or changing doses of medications that you arealready taking.

Yes
 

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Molecular and Precision Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03785249
STUDY00014803
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Inclusion Criteria:
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation.
Unresectable or metastatic disease.
Presence of tumor lesions to be evaluated per RECIST 1.1:
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1.

Exclusion Criteria:
Active brain metastases.
Patients with carcinomatous meningitis
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose date
Undergone major surgery within 4 weeks of first dose date
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications
Cancer
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Hershey, PA ,

Campus Environments and Student Health

The purpose of this study is to learn about the relationship between the campus environment and students’ health. It involves a survey consisting questions about campus-related activities, COVID-19, physical activity and health, environmental perceptions, and demographic information.

There will be an online survey that will take about 20-30 minutes. No need to meet in-person.

No
 

Amaryllis Park
Amaryllis Park - at ahp5234@psu.edu or 281-628-6496
Landscape Architecture (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022472
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Inclusion Criteria:
Currently enrolled as a student (part-time or full-time)
At least 18 years old or older

Exclusion Criteria:
Younger than 18 years old
Mental & Behavioral Health
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A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease

Crohn's disease is a chronic, incurable inflammatory disease of the digestive system. Current treatment advancements need to be improved to meet patient's needs. This study is a 24-week treat-through design (meaning Induction and Maintenance treatment without re-randomization) using either monotherapy (single drug) or combination therapies (two drugs) in moderate to severe Crohn's disease. The participants who are responders will be able to continue treatment in Long Term Extension (LTE) study phase, weeks 24 to 96. This study aims to evaluate the safety and effectiveness of each combination therapy compared to conventional monotherapy.

Subjects will be required to sign the informed consent, and attend in person visits. They will be required to complete daily eDiary, and have tests and procedures done per protocol timeline. Procedures include blood tests, colonoscopies with biopsies, ECG, vitals and physical exam. Pregnancy testing will be done for WOCBP.

$77 per completed visit and $100 for completed endoscopy. Travel will be reimbursed up to $52 for each visit. You will be given $24 for meal if the visit required fasting.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06548542
STUDY00025277
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Inclusion Criteria:
Subject is aged 18 to 70 years
Subjects' body weight must be ≥ 40 kg at
Confirmed diagnosis of CD for at least 3 months
Endoscopic evidence of mucosal inflammation
Intolerance or inadequate response to 1 or more standard treatments including one biologics

Exclusion Criteria:
History of drug and alcohol abuse in the last 6 months
Major surgery 3 months prior
Active HBV or HCV infection, TB infection or HIV positive
C. difficile positive or other intestinal pathogen
UC or indeterminate colitis
Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes

The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.

The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 3 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. •The survey will take approximately 10 minutes of your time. •Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so.•At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.

Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).

No
 

Neerav Goyal
Hanel Eberly - at HNCtaste@pennstatehealth.psu.edu
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019457
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Inclusion Criteria:
Able to give consent
Over the age of 40
English Speaking

Exclusion Criteria:
Under 40 years of age
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
Cancer
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Comparing Mechanisms of Pattern Learning

The purpose of the proposed plan of research is to investigate the types of patterns that human adults with or without a history of language/ learning difficulties tap into as they learn.

Our study involves an initial testing session lasting between 1-2 hours, followed by up to two additional sessions for eligible participants. As part of our study, you will take part in some speaking, listening, learning, and visual processing tasks.

up to $75

No
 

Roger Beaty
jzp6211@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017229
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Inclusion Criteria:
Age 18-28
Only speaks English fluently
Normal or corrected-to-normal vision/ hearing
Minimum of high school education
May have a history of language/ learning difficulties

Exclusion Criteria:
History of neurological injury or disease
Speaks more than one language
Under age 18
Over age 28
Does not have minimum of high school education
Language & Linguistics
Not applicable
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Emotion Regulation and Mother-Infant Synchrony

The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.

Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.

40

Yes
 

Berenice Anaya
Berenice Anaya - at bua25@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00018109
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Inclusion Criteria:
Infants who are 4 months and their mother.
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.

Exclusion Criteria:
Infants who were < 2500 g at birth.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Children's Health, Neurology
Not applicable
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State College, PA ,

SNAC Study

This is a multi center clinical trial to test the efficacy of N-acetylcysteine for treatment of patients with active systemic lupus Erythematosus. Healthy control subjects who do not receive treatment are also recruited to serve as controls for the laboratory assays.

This is a clinical trial to be carried out in patients who have systemic lupus erythematosus. Participants will be asked to attend seven study visits over a period of 13 months. After an initial period where it will be determined that the patient can tolerate the medication, N-acetyl cysteine, then there will be a three-month double blind phase where the participant receives either the active treatment or a placebo. At each visit the participant will be asked to complete several questionnaires and blood and urine samples will be obtained. Healthy control individuals will be also enrolled for blood samples only; not for any treatment intervention.

$20 per visit completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00775476
SITE00001115
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Inclusion Criteria:
Diagnosis of Systemic Lupus Erythematosus
Age 18 years or older
On stable medications
Experiencing flare of disease

Exclusion Criteria:
pregnant or lactating
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

AIDP

The purpose of this study is to test the performance of a web-based system for automated review of MRI images across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Participants will attend two study visits that will include questionnaires, a physical exam and motor exams and an MRI (during one of the visits).

300

Yes
 

Sol De Jesus
Autumn Collier - at acollier3@pennstatehealth.psu.edu or 717-531-5233
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00001044
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Inclusion Criteria:
40-80 years old at baseline
Diagnosed with a Parkinsonism (PD, MSA or PSP)

Exclusion Criteria:
Unable to undergo an MRI
Neurology
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Hershey, PA ,

A Survey of the Sex Differences in Taking Selfies while Driving

This study aims to understand peoples’ selfie-taking behavior and how, if at all, they relate to their driving behavior and gender difference. The participants will participate the study by completing an online survey.

No
 

Yiqi Zhang
Josh Avalos - at jqa5409@psu.edu or 610-716-7976
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016045
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Inclusion Criteria:
Subjects who are 18 years of age or older
Subjects have a valid U.S. driver license or are allowed to drive in the US

Exclusion Criteria:
Subjects who under 18 years of age
Subjects who do not have a valid U.S. driver license or are not allowed to drive in the US
Education, Language & Linguistics
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Olfactory tools for COVID-19 screening and surveillance

This a collaborative multisite NIH funded project to develop smell tests as a rapid low cost way to screen for Covid19 infections. The lead institution is the University of Florida, and this project is being entered into CATS to create a Reliance Agreement under the NIH single IRB rules (sIRB).

No
 

John Hayes
Elisabeth Weir - at efw5195@psu.edu
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
SITE00000951
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Inclusion Criteria:
Aged 18 to 99
COVID19 negative
COVID19 positive
Able to Consent in English

Exclusion Criteria:
Inability to provide consent
History of known pre-existing olfactory or taste disorder
History of head trauma with loss of consciousness
History of neurodegenerative disease
COVID-19
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Predicting Concussion Outcomes with Salivary miRNA

The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows:1)Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.2)Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.

Saliva collection and surveys at baseline, 7 days, and 30 Days

$20

Yes
 

Jayson Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
Family and Community Medicine (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
NCT02901821
STUDY00003729
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Inclusion Criteria:
5 to 23 years of age
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion

Exclusion Criteria:
Does not speak english
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Children's Health, Neurology, Sports Medicine
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Hershey, PA ,

Observations of Family Mealtime Routines

The purpose of this study is to gather information about what family mealtimes look like for families with children between the ages of 3 and 8. Families will be asked to video record their family mealtime, in addition to answer some questions and to complete some questionnaires, some about body image and dieting.

On one occasion, your family's mealtime will be recorded via Zoom. You and your family will be asked some questions and to complete some questionnaires online.

$20

No
 

Hannah Mudrick
Hannah Mudrick - at hxm99@psu.edu or 717-948-6404
Behavioral Sciences and Education (HARRISBURG)
 

All
All
This study is also accepting healthy volunteers
STUDY00015339
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Inclusion Criteria:
At least one adult who is the caregiver of at least one child between age 3 and 8 (e.g., at least one parent-child dyad)
Adults age 18 and older
Children, ages 3-8
Individuals fluent in English

Exclusion Criteria:
Non-family members, as defined individually by each family
Caregivers who are under the age of 18
Individuals who are not fluent in English
Families without at least one child age 3 to 8
Children's Health, Food & Nutrition
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Human-robot interaction study

We are interested in developing robots that can interact with humans. We hope that to develop robots that can interact with people and be used in a variety of different situations such as schools, offices, and homes. This study investigates human-robot interaction.

Yes
 

Alan Wagner
Alan Wagner - at alan.r.wagner@psu.edu or 814-865-3136
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010270
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Inclusion Criteria:
Ability to read and see

Exclusion Criteria:
Under 18
Education
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State College, PA ,

Behavior, Voice, and Sex Hormones Study

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

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

$330

Yes
 

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

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

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

PSCI-22-063: NRG-GU011 NRG Promethean

This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.

Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.

Yes
 

Joseph Miccio
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05053152
SITE00001224
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.

Exclusion Criteria:
Evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

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

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

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

1220

Yes
 

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

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

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

PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER

This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.

Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.

Yes
 

Zain Siddiqui
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05946213
STUDY00025462
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18

Exclusion Criteria:
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
Cancer
Not applicable
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Hershey, PA ,

Understanding Prenatal Hydration Behaviors

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

No
 

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

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

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
Food & Nutrition, Mental & Behavioral Health, Women's Health
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A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab versus GS-1427 or Ustekinumab monotherapy

The study will test GS-1427 for treatment of ulcerative colitis (UC). Adults diagnosed with UC can participate if otherwise eligible.The study has two parts; the first part lasts 12 weeks. Participants will be randomly assigned to either a treatment or a placebo arm. At 12-week evaluation the participants can be further assigned to an active treatment lasting 40 weeks. The second part of the study is for new participants. Eligible participants will be randomized to the treatment with GS-1427, Stelara, or both drugs.The study procedures include blood tests, endoscopy with biopsies, vitals, and physical exam, EKG testing, providing urine and stool samples, and completion of symptom-related diary questionnaires.

Participants will be required to sign the informed consent and show that they understand the study requirements. They will be required to complete in-person clinic visits. During the visits, the participants will have their vitals checked, and we will ask them about any problems they may have or adverse events. During the screening periods, participants will undergo endoscopy with biopsies and provide stool and urine samples. Blood draws will also be done, and we will teach them to complete the questionnaires about the disease symptoms. If eligible for the study, screened subjects will be randomized for either tone of the three drug dose or placebo treatment (blinded). They will attend at least five clinic visits over the twelve-week treatment period. At that time, the endoscopy evaluation will be done again, and the participants will be eligible to enter the next study phase. They will again be randomized to one of the four possible treatment arms using different drug doses. In the part 2, investigational drug, standard of care biologic Stelara, or concomitant treatment of both medicines. During part 2 of the study, subjects are required to attend at least ten clinic visits every four weeks. When the treatment is completed, the participants will be followed for four weeks and attend the end of the therapy visit. The final endoscopy will be done at week 52 of treatment. Participants will have an ECG done at selected study visits and a pregnancy check for WOCBA at every visit. Blood draws and a review the study diary will be done at every visit.

Part 1 total $1765 ($75 per visit, $20 meal cards v2 and v12); Part 2 TBD

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06290934
STUDY00024299
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Inclusion Criteria:
age18-75 years
diagnosed UC at least three months prior
active disease inspite of one of the standard therapies
loss of response, or intolerant to not more than one therapy
negative TB test and HIV at screening

Exclusion Criteria:
diagnosis of Crohn's disease
history of ileostomy, colostomy or stenosis
history of extensive colonic resection
past treatment with vedolizumab
past treatment with ustekinumab
Digestive Systems & Liver Disease
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Hershey, PA ,

Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context

This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.

Yes
 

Benjamin Hanrahan
Ning Ma - at nzm37@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013808
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Inclusion Criteria:
Taken at least 10 Uber/Lyft ride in the last 12 months.
You are willing to share several of your past Uber/Lyft trip records in the app with us.

Exclusion Criteria:
You are a current or past employee with one of the ride-sharing corporations (Uber/Lyft)
Education
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State College, PA ,

Evaluation of the reliability and convergent validity of the Pain Competency Evaluation in Dementia (PACED) Rating Scale

This study establishes the reliability and convergent validity of the PACED rating scale. 15 undergraduate nursing students and registered nurses will be recruited to complete 2 clinical scenarios related to nursing home residents with dementia experiencing pain and symptoms of distress. Participants will use their clinical judgment to conduct assessments and provide interventions and treatments.

Participants (nurses and nursing students) will be asked to complete a demographic survey, a pain management knowledge survey (POAKS), and complete 2 clinical scenarios followed by pain management notes related to persons with dementia experiencing symptoms of distress. It may take about an hour to complete the study procedure mentioned above. You can choose to complete the 2 clinical scenarios in one setting or at different times.

$25 gift card for Registered Nurses (RN) and nursing students.

No
 

Yo-Jen Liao
Yo-Jen Liao - at yzl541@psu.edu or 814-826-8603
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022937
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Inclusion Criteria:
English Speaking
18-years old or older
Undergraduate nursing students or Registered Nurses (RN)

Exclusion Criteria:
None
Pain Management
Not applicable
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease

This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.

The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.

$100 per completed visit, $250 per endoscopy

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06430801
STUDY00025295
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Inclusion Criteria:
Read, understood, and provided written informed consent
Individual of any sex/gender from 18 years to 75 years of age inclusive,
Has had disease more than 3 months and has moderately active disease with one of the standard therapies
Average daily very soft or liquid SF ≥4 and/or average daily APS ≥2 at Baseline.
Demostrates loss of response, intolerance or inadequate response to standard therapy

Exclusion Criteria:
Has a diagnosis of UC, or indetermined colitis
Has CD without colonic involvement
Has known colonic stricture or colonic stenosis
Has current stoma
Is missing more than two colonic segments or has short bowel syndrome
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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See this study on ClinicalTrials.gov
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Hershey, PA ,