Search Results
NUTRI-Beta Study: A Pilot Clinical Trial for Children with New Diagnosis of Stage 3 Type 1 Diabetes
This will be a 12-week single blinded, randomized, nutrition clinical trial for children with new diagnosis of stage 3 type 1 diabetes (clinical diagnosis of T1D). Beta cell function will be measured after 3 and 6 months.
Study participants in the intervention group will be required to follow the intake of specific foods and adhere to specific nutrition guidelines in addition to follow with a registered dietitian for 12 weeks (4 in person visits and 3 virtual visits). All these visits will be compensated. All study visits will be seen for a screening visit, an enrollment visit, 12-week visit and a 24-week visit. During the study visits, participants will undergo the following: physical exam/ demographic/social evaluation, clinical nutrition evaluation, nutrition counseling, dietary intake assessment, blood test collection, 2-hour Mixed Meal Tolerance Test (MMTT) and anthropometry.
$345
Age 6-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Positive antibodies for type 1 diabetes
History of seafood allergies and/or milk/dairy related allergies
Type 2 diabetes
Food sensory disorders
Pubertal children
Research on Survivorship Experiences: Disparities in cancer-related outcomes between rural and non-rural cancer survivors in the catchment areas of the Big 10 Cancer Research Consortium's Population Science Working Group
The objective of this cross sectional survey study is to describe the social and psychological outcomes of cancer survivors and characterize the disparities between rural and non-rural cancer survivors. We will collaborate will members of the Big 10 Cancer Research Consortium's Population Science Working Group to invite cancer survivors in rural and non-rural communities to complete one online survey, with each site targeting cancer survivors in their catchment areas. At Penn State, we will target recruitment to cancer survivors living in Pennsylvania. We plan to enroll 150 participants. It will take participants 30-40 minutes to complete the study and they will receive a $15 Amazon gift card for their time and effort.
If eligible, study participants will be asked to complete one online survey about their experience as a cancer survivor. Potential participants will first complete a REDCap screening form, if eligible, they will view the consent form. If they provide consent, they can complete the survey. A member of the Penn State study team will call the participant to confirm eligibility and once confirmed, will issue a $15 Amazon e-gift card. The entire study should take between 30-40 minutes to complete.
$15
non-metastatic cancer
1-5 years post completion of active treatment
no current evidence of cancer
living in certain counties in south central Pennsylvania
cannot speak or read English
unable to provide informed consent
less than 18 years old at time of cancer diagnosis
Dining Out in NYC: Using VR to investigate the influence of multisensory urban design factors on eating behavior in emerging adults
This study uses virtual reality to investigate how sensory aspects of an environment influence eating behavior. Specifically, subjects will be immersed in a virtual outdoor café environment and consume a standardized meal while being exposed to either a pleasant or unpleasant smell. Total food intake and mood will be measured following each visit.
Answer initial screening and demographics questionnaires. Two in-person visits to the lab to experience a VR setting and consume a provided meal. One visit will include a small hair sample. Answer questionnaires following the VR experience.
$20 in Amazon gift cards
Fluent in English
Not color blind or nose blind
No food allergies/sensitivities
No diagnosis of mental or physical disabilities that may affect appetite, eating behavior, or body awareness and balance (such as eating disorders, Major Depressive Disorder, epilepsy, and vertigo)
Not fluent in English
Color blind or nose blind
Self-reported food allergies/sensitivities
Have diagnosis of mental or physical disabilities that may affect appetite, eating behavior, or body awareness and balance (such as eating disorders, Major Depressive Disorder, epilepsy, and vertigo)
The Use of Micro-Doppler Radar for Fall Risk Assessment: A feasibility pilot
The purpose of this research is the understand the feasibility of using radar to identify older adults at high-risk for falls. We will enroll two groups of participants 65 and older: one group who self-report at least one fall in the past year and a control group that has no reported falls. Participants will move in front of the radar tool while we measure their movements. We will use machine learning algorithms to determine if there are differences in the movement patterns of those who have fallen versus those who have not. We hope that using the radar tool will be an effective method of identifying older adults at high risk for falls, thus enabling fall risk prevention interventions.
Participants 65 and older will come to one, 30-minute in-person visit at the Lebanon Valley College in Annville, PA and will perform a variety of movements that mimic activities of daily living. You will be asked to stand still, to get up and down from a chair, and to walk a short distance. You will be asked to repeat each of these movements several times while study team measures these movements with a radar device.
$20
able to walk 20 feet without stopping
able to walk without assistive devices
Fall Group: at least 1 fall in the past year
can read and write in English
self-reported chest pain or shortness of breath when walking less than 20 feet
any surgeries in the past 3 months
history of lower extremity surgery that would alter normal gait mechanics (e.g. amputation))
chronic neurodegenerative disease or cognitive impairment
Children's appetite regulation study
The purpose of this study is to determine whether girls and boys regulate their appetites differently. Children will attend 1, 3 hour session in the laboratory, complete some surveys and health measures, donate saliva, and eat pizza.
Children will come to the lab for a 3.5 hour session where they will wear a heart rate monitor, conduct some surveys, have their veggie intake measured, provide some saliva, and eat some pizza. Parents will attend the lab visit with the child and complete questionnaires about feeding and the home environment.
$50 plus travel costs for > 20 miles from lab
Healthy without food allergies
Parent in charge of feeding able to attend with child
Children with medical problems or taking a prescription medication that may affect appetite
Children who are not willing to eat pizza in the laboratory
The parent in charge of feeding decisions cannot attend with the child
Maintenance Obinutuzumab for primary central nervous system lymphoma complete or partial responders
The study will compare participants with primary central nervous system lymphoma which responded to initial treatment and are thereafter treated with Obinutuzumab (the study drug), with participants with primary central nervous system lymphoma which responded to initial treatment and are not treated with the study drug.
In addition to your routine care, you will be “randomized” into one of the study groups described below. You will have a MRI of your brain approximately every three months (plus or minus two weeks) for two years. You will undergo a neurocognitive assessment and complete a quality-of-life questionnaire two years after study entry.Group A – Obinutuzumab ArmIf you are in the first group ("Group A") you will be given the study drug every two months for two years. Every two months you will have your vital signs taken, your blood drawn (one to two tablespoons), and you will be given the study drug through an IV infusion into your vein. Group B – No Obinutuzumab ArmIf you are in the second group ("Group B") every six months you will have your vital signs taken and your blood drawn (one tablespoon).
Must have undergone first-line treatment with high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy
Must be within 75 days of completion of first-line treatment regimen at the time of randomization
18 years or older
Clinical evidence of extra-CNS (systemic) non-Hodgkin lymphoma.
Known hypersensitivity to any of the study drugs.
History of other malignancy that could affect compliance with the protocol or interpretation of results
Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization
Exploring the effects of nighttime indoor light exposure on children with autism spectrum disorder
This study aims to identify potential differences in psychological and physiological responses to indoor light at night and to offer recommendations for optimizing the sleep patterns, circadian rhythms, and sensory regulation of children with ASD.
Parents and/or caregivers of children with ASD will fill out surveys and collect saliva samples.
20
Aged 9-15
Sleep difficulties
Disorders such as sleep apnea, restless legs syndrome, or periodic limb disorder during sleep
Children with fragile X syndrome, Down syndrome, neurofibromatosis, or tuberous sclerosis complex and children who had a non-febrile unprovoked epileptic seizure within the last two years
von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in von Willebrand Disease for Childbirth
Specific guidance is lacking for pregnant women with von Willebrand Disease (VWD) and delivery planning in terms of how high a von Willebrand factor (VWF) level should be achieved. Specifically, guidance is lacking on whether replacement therapy drugs (Wilate & Tranexamic Acid) should target a VWF minimum level. This study is a prospective study to document the rate of primary postpartum hemorrhage (PPH) and the effectiveness of the dosing of Wilate, looking to provide increased management and guideline recommendations.
Pregnant women will come to clinic at 34-38 weeks of pregnancy, observation at time of labor or C-Section, during delivery,72 hrs. post delivery & 5-7 days vaginal delivery or 7-10 days if C-Section.
Type I National Heart, Lung & Blood Institute criteria
Gestational weeks 34-38
Presence of liver or renal disease
Suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP or DIC
PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED
This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.
Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
PSCI 23-002 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2-Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
We are asking you to take part in this voluntary research study because you have ER+/HER2- early breast cancer with no evidence of disease following surgery. The purpose of this voluntary research study is to better understand the studied disease and associated health problems.
Participants will be required to come to all study visits, take the medication an instructed, let the study team know what medications you are taking, especially over the counter ones and to report any changes in how you are feeling.
Patient must be ≥18 years
histologically confirmed ER+/HER2- early-stage resected invasive breast cancer
a history of previous breast cancer
Chronic gastrointestinal disease
Major surgical procedure or significant traumatic injury within 2 weeks of randomisation
Feasibility and Acceptance of Financial Data Collection in Populations with Bipolar Disorder
Risky financial behaviors during symptomatic episodes of bipolar disorder are included in the diagnostic criteria of this psychiatric illness. Literature has called for granular, longitudinal financial data analysis, although only recently have open banking technologies made this a more realistic possibility. Participaints will be asked to use a data collection application in order to submit financial transaction data via Plaid's open banking API.
In a one-time Zoom session, participants will:--Complete surveys about demographic information and clinical scales related to bipolar disorder. --Interact with an application to securely transfer their deidentified financial records to be compared with clinical scales --Provide insights on their financial behaviors in relation to bipolar disorder, current financial management practices and challenges, and the involvement of others in these management practices
$50
Has a bank account accessible by Plaid API (most financial institutions are supported)
Access to a personal device capable of participating in Zoom calls for orientation and interviews
English-speaking
Currently residing in the US
Major physical illness or cognitive impairment affecting their participation
Lack of access to a personal device capable of participating in Zoom calls for orientation and interviews (e.g., only has access to phone or tablet)
No banking access or unable to access personal web banking features through a financial institution compatible with Plaid API
Non English speaking
PSCI 24-041 Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
This trial will compare the use of elacestrant versus standard endocrine therapy in those who are node positive, ER +, Her2 - with high risk of the cancer coming back
Participants will be expected to come to all visits, take all study medication as instructed by the study doctor, report any new medications, prescription or over the counter, report all side effects.
Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and ISH-negative)]
Participants considered at high risk of recurrence
Participants who have received at least 24 months but not more than 60 months of endocrine therapy
Participants are to be between 2 to 6 years from the date of curative surgical resection
Participants with stage IV metastatic breast cancer.
History of any prior (ipsilateral and/or contralateral) invasive breast cancer
Major surgery within 4 weeks of starting study therapy
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study toAssess the Efficacy and Safety of Barzolvolimab in Patients withChronic Spontaneous Urticaria Who Remain Symptomatic DespiteH1 Antihistamine Treatment (EMBARQ – CSU2)
A clinical research study called EMBARQ-CSU, which seeks to assess an investigational study medicine that has the potential to expand treatment options for Chronic Spontaneous Urticaria (CSU). CSU is a skin condition also known as chronic hives or long-term hives that is characterized by raised itchy welts on the skin that persist for six weeks or longer with no known cause.
If you decide to take part in this research study, you will have a screening phase where you will have procedures to determine if you meet the requirements to be in the study. These include a physical exam and an electrocardiogram (ECG) which will measure the electrical activity of your heart. You will also be required to give blood and urine samples. If you are a woman who can have children, you will also need to take pregnancy tests.If you qualify and agree to take part in the study, you will receive injections of barzolvolimab or placebo (the placebo contains the same ingredients but without barzolvolimab) under your skin every 4 weeks for 6 months. After 6 months, everyone will receive barzolvolimab for an additional 6 months, involving visits every 4 weeks. During the study, you will continue to have physical exams, blood taken for testing, and urine tests.You will need to complete a daily diary.
Diagnosis of CSU ≥ 6 months prior to Screening.
CSU remains despite a stable dose and regimen containing a second-generation antihistamine.
Agree to use highly effective contraception.
Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout of the study.
Diseases with possible symptoms of urticaria or angioedema.
Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Screening.
Diagnosis of idiopathic anaphylaxis or a history of anaphylaxis.
Women who are pregnant or nursing.
Evaluating Nurses’ Pain Management Competency in Dementia Using the Pain Competency Evaluation in Dementia (PACED) Scale
This study examines nurses' pain management competency in nursing home residents with dementia using the PACED Scale. Specifically, we will recruit 60 Licenced Practical Nurses (LPNs) and 60 Registered Nurses (RNs) working in nursing homes in Pennsylvania. The PACED Scale is an established scale by the principal investigator to evaluate nurses' pain management competency in persons with dementia and this study will use the PACED scale to rate the nurses' pain management competencies.
Participant will complete a 1-hour study online, including a demographic survey and 2 virtual clinical scenarios and pain management notes related to residents with dementia experiencing pain.
$25 gift card
English speaking
Working as a RN or LPN in nursing homes for more than 3 months in Pennsylvania
Have professional experience caring for persons with dementia
PSCI-24-092 A PHASE 1, OPEN-LABEL, MULTICENTER STUDY OF JANX007 IN SUBJECTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
This trial will examine different doses of JANX007 to find the safest dose to treat metastatic castration resistant prostate cancer (mCRPC)
Participants will be required to come to all clinic visits, report any symptoms they are having and all medications they are taking, including over the counter medications.
Histologically or cytologically confirmed adenocarcinoma of the prostate
Serum testosterone <50 ng/dL
Documented progression
Progressive mCRPC or intolerance to the most recent therapy
Prior treatment with PSMA-CD3, PSMA-CD28, or other CD3-T cell engaging bispecific antibodies.
Prior solid organ transplant
Use of any herbal products that could decrease PSA levels
PSCI 23-101 A Phase IIIb, Randomized, Multicenter, Open-label Study to assess the Efficacy of Durvalumab plus Tremelimumab versus Pembrolizumab in Combination with Platinum-BasedChemotherapy for First-Line Treatment in Metastatic Non-SmallCell Lung Cancer Patients with Non-Squamous Histology whohave Mutations and/or Co-mutations in STK11, KEAP1, or KRAS(TRITON)
A study to investigate how multiple medications combined with chemotherapy work compared to another medication in combination with chemotherapy work in NSCLC patients
•You will be asked to provide general information about:Your general health: personal data (date of birth or age, sex, race, and ethnicity), medical and surgical history, and details of your past and current medicationsYour general well-being and activities of daily life will be recordedoYou will be asked how you are feeling and any health problems you are having•The following procedures will be performed:Vital signs (including weight, blood pressure, temperature, breathing and pulse rate)A full physical examinationHeart function tests: ECG, echocardiogram (ECHO), or multiple-gated acquisition scan (MUGA), and cardiopulmonary assessmentScans: tests done to take pictures of and measure your cancer, may include computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scans of your brain, chest, and abdomen
Age 18 or older
Willingness of a woman to use birth control
Men willing to use birth control during and 11 months after the last study treament
Breastfeeding
under the age of 18
PSCI 24-114: A Phase II Study Of Tailored Adjuvant Therapy In Pole-Mutated And P53- Wildtype/NSMP Early-Stage Endometrial Cancer (Rainbow Blue & Taper)
This study is to find out if there are types of early-stage endometrial cancer that require less treatment than the usual approach. Based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor may recommend Sub-study A or Sub-study B. Based on this assessment, subjects may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of your usual treatment.
Treatment that will be recommended to the subject will be based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor might recommend that the subject participate in Sub-study A or Sub-study B. Based on this assessment, the subject may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of their usual treatment After the subject finishes study treatment, and even if they stop treatment early, the study doctor will continue to follow the subject's condition, watch the subject for side effects and keep track of the subjects health. The subject will be seen after 3 months and 6 months, then every 6 months for 3 years, and then every year after starting the study until the study closes. The subject may be seen more often if subject's study doctor thinks it is necessary.
Patients’ Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
Patients’ age must be greater than18 years.
Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Prior pelvic radiation.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.