Search Results
EA9161: A Randomized Phase III Study of the addition ofVenetoclax to Ibrutinib and Obinutuzumab versus Ibrutiniband Obinutuzumab in Untreated Younger Patients withChronic Lymphocytic Leukemia (CLL)
The is a drug study to compare the progression freesurvival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Biobehavioral Health Risk and Resilience in College Students (PSU THRIVE Study)
This protocol is designed to examine biobehavioral health risks, resilience, grit, forgiveness and well-being in college students.
18 to 24 years of age
English is a primary language
Under age of 18 years
Over age of 24 years
Not comfortable speaking English
Linking olfactory deficits to memory impairment and AD neurodegeneration
The purpose of this voluntary research study is to find out more about changes in the brain as we age. This study is trying to determine if magnetic resonance imaging (MRI), genetic variations, amyloid positron emissions tomography (PET), neuropsychological testing, and smell tests can be used to evaluate memory loss and cognitive impairment.
You will be asked to come to the research site once a year for 5 years.Annual (and semi-annual) procedures include completing smell tests, neuropsychological tests, magnetic resonance imaging (MRI). One-time procedures include provide blood sample, amyloid PET scan (if indicated), and optional lumbar puncture.
Up to $250 a year
Smell impairment
Women who are pregnant or breastfeeding
Currently smoke
Have claustrophobia
An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC.
At the study visits, the following procedures should happen:• Your study eligibility will be determined• There will be a review of your current medications and medical history• You will undergo a physical examination that includes measuring your height, weight, taking your vital signs, checking your heart with an electrocardiogram, and determining your ECOG performance status (a measure of your daily functional activity)• You may undergo tumor biopsy if clinically feasible according to your doctor or may be asked for a previously collected sample. You will be asked for a previously collected tumor biopsy if clinically feasible by your doctor• Blood and urine will be taken to determine the function of your liver, kidneys, and bone marrow function.• Blood samples will also be collected to assess potential changes in biological molecules in the blood such as certain proteins and pieces of DNA shed from tumor cells • You will receive a variety of imaging procedures to determine the status of your cancer throughout the study. These will include CT and PET scans, bone scans and may include other scans like X-rays and MRI scans.• On repeat visits, your doctor will ask you about any changes in the way you feel
Patients must have an ECOG performance status of 0 to 2
Patients must be adults >= 18 years of age
Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan
Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
Patients with a history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Patients with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
Patients who received transfusion for the sole purpose of making a subject eligible for study inclusion
Graduate Students’ Experience with Online Professional Profiles and Social Media
With the development of information and communication technologies, Social Network Sites and other online platforms can be great resources for career-related information and social networking. Despite the evidence of possible professional benefits, it remains unclear whether graduate students’ experiences with building online career profiles and social networking are positive. Therefore, this study aims to understand graduate students’ experience with professional practices on the Internet concerning their motivations, benefits, and risks.
An active graduate student at University Park campus
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
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
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
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
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
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.
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.
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
Imaging and Depression with or without MS
A study looking at the neural and genetic correlates of depression. Presently, the current study is looking to recruit individuals for two separate groups: 1. MS but NO history of depression2. Depression but NO history of MS or neurological disease. The purpose of the study is to look at patterns of brain structure and function in individuals with depression and compare them to those with MS. We will explore how any differences we find contribute to more problems with depression in MS and see how such differences might lead to better treatment options for depression.
Able and willing to undergo an MRI
Able to travel to State College for the Study
Started anti-depressant medication in the last 2 months
Diagnosis of bipolar disorder, schizophrenia, or significant neurocognitive impairment
Very severe depression that would interfere with the ability to participate or suicidal ideations
Unable to undergo an MRI (metal in your body)
Postmenopausal women and their endothelium: Is dietary nitrate supplementation protective?
Heart disease is the leading cause of death in the United States. The loss of estrogen from menopause puts women at a greater risk of developing heart disease. The purpose of this study is to determine the effects of drinking beetroot juice on measures of blood vessel health and blood pressure. Participants will drink beetroot juice and placebo juice each for one week followed by blood pressure measurements and ultrasound imaging of an artery in the upper arm. A sub-aim of this study is to investigate the effects of estrogen status on blood vessel function between pre- and post-menopausal women.
There are a total of 6 in-person visits to the Clinical Research Center. You will be asked to drink beetroot juice (2 oz) every day for 7 days. Participants will undergo vascular assessments, blood pressure measurements, and blood draws (11 in total for 6 visits).
$120
BMI <35
Blood pressure <130/80
LDL <170 mg/dL
Individuals with resting blood pressure > or = 130/80 mmHg
Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
Individuals with any overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
Individuals with active cancer
Slips of Action in Adolescents and Young Adults
Adolescence is a critical period during which many important healthhttps://irb.psu.edu/IRB/sd/ResourceAdministration/Project/ProjectEditor?Project=com.webridge.entity.Entity[OID[058ACDEB3E43384D816C7E390C2B83F6]]&Mode=smartform&WizardPageOID=com.webridge.entity.Entity[OID[E4552FC57E491543A6B7FD8268E23FD7]] habits form in humans. However, animal models provide mixed information about habit formation across development and there are relatively few human studies that address differences between habit formation in adolescents and adults. To address this gap, the proposed study will assess differences in habit formation in adolescents and adults as measured by the "Slips of Action" task, which seeks to discriminate between habitual and goal-directed learning of visual stimuli pairings.
There will be one in-person visit lasting about one hour. Visits will begin with informed consent. Participants will complete a computer task where they are asked to learn associations between pictures and then will be tested on the associated pairings. They will also complete questionnaires and cognitive tasks.
$20
Healthy adults between the ages of 25 to 40
No learning disabilities (e.g., ADHD) or diagnosed psychological conditions (e.g. anxiety)
Right handed
Not on any medications known to influence behavior
Diagnosed neurological or psychological condition including severe anxiety and/or depression, schizophrenia, learning disability, ADD/ADHD, or autism
Significant family history of neurological or psychological disorders
Left handed
Participant is on any medication that may influence behavior
Reducing Perception Error in Diagnostic Radiology
This research is being done to find out the relationship between an individual’s mental state and how well they perform visual-perceptual tasks. This will allow us to understand the brain processes related to errors in image perception, to understand how mental states impact medical image interpretation. Overall, this research will help us develop training programs to reduce the amount of perceptual errors in diagnosing images
Healthy adults, with college or advanced degree
Normal or corrected to normal vision
Pregnant or lactating
Presence of pacemaker, aneurysm clips, or any metal in the body
A history of welding or grinding
Claustraphobia
PSCI 22-141 CCTG MA.39: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer
To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
Endometriosis and microvascular dysfunction
Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.
There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.
390
Endometriosis
Pregnant and/or breastfeeding
Taking blood pressure medication
REGIMEN-SPECIFIC APPENDIX FFOR ABBV-CLS-7262
We are doing this research to find out if ABBV-CLS-7262 can help with Amyotrophic Lateral Sclerosis (ALS). We also want to find out if ABBV-CLS-7262 is safe to take without causing too many side effects.
•Ask you to complete questionnaires about your general health and well-being [Baseline Visit and Weeks 4, 8, 16 and 24/Early Termination (ET) Visits] •Collect a blood sample for:oTesting the amount of study drug in your body [Weeks 4, 8, 16, and 24/ET]oTest certain hormone levels [Regimen Screening, Week 4, 16, and 24/ET]oTest for a bleeding disorder prior to lumbar puncture [Regimen Screening if not done at Master Protocol Screening Visit, Week 16] oBiomarker (including RNA) testing [Baseline Visit, Week 8, 16, and 24/ET]oOver the course of the placebo-controlled portion of this research study, total blood draw volume for the samples listed above will be approximately 32mL or 2 tablespoons per visit •Collect a urine sample for:oRoutine safety testing [Baseline Visit, Week 4, Week 8, 16, and 24/ET]oBiomarker testing [Baseline Visit, Week 8, 16, and 24/ET]•Collect electrocardiogram (ECG) to assess for cardiovascular safety [Baseline Visit, Week 8, 16, and 24/ET]•Collect your vital signs (blood pressure, breathing & heart rate, blood oxygen level, and temperature)•Perform a lumbar Puncture to collect spinal fluid [Baseline and Week 24 Visit]•If you are a woman of childbearing potential, you will be asked to complete a Menstrual Cycle Questionnaire throughout the duration of this regimen
You will receive payment for the following: 1.stipend of $50 per on-site visit; 2.stipend of $100 per lumbar puncture (LP requested Weeks 28 and 52); 3.reimbursement for travel of $65 per on-site visit.
Age 18 years or older
Capable of providing informed consent and complying with study procedures, in the SI’s opinion
Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit
Abnormal adrenal function, defined as confirmed abnormal random cortisol (<5 μg/dL) or ACTH (>2x upper limit of normal) at Regimen Specific Screening.
Any clinically significant ECG abnormalities, including QT interval corrected for heart rate using Fridericia’s correction formula (QTcF) of > 450 msec for males or > 470 msec for females at Master Protocol Screening.
Evaluation of the Immune Response and Antigenic Signature of Patients with Babesia Infection in Pennsylvania with the Aim of Developing a Rapid Diagnostic Test
We are evaluating patients who have been infected with Babesia. Babesia is a blood parasite that is acquired from ticks. The number of cases seen in Pennsylvania every year has been increasing. We intend to evaluate the blood of patients acutely infected with Babesiosis and review for possible simultaneous co-infections. We will compare those infected patients with the blood of healthy individuals. The goal is to identify proteins in the blood of acutely infected patients that are specific for Babesia and also evaluate the prevalence of patient's who have contracted a co-infection from the tick vector that transmitted the Babesia infection. The identification of the specific bacterial/parasitic antigens could then be used to create rapid diagnostic tests and help clinicians increase awareness of these tick-borne diseases.
We will obtain basic demographic information and past medical history. We will obtain two 10ml samples of blood. The blood will then be stored and ultimately sent to Antigen Discovery, Inc for proteomic array screening.
18 years or older
History of having your spleen removed
History of liver or kidney disease
HIV
Diabetes
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Perception of English sentences in context
This study tracks the eye movements of 30 adults to gather information on how they process sentences when presented in a context.
native speaker of American English
grew up mainly in the US
not a native speaker of American English
did not grow up mainly in the US
Comparison of Two Methods of Genre-based (Research Article) Writing Instruction
The different effects of genre-based writing instruction and integration of technology use in genre-based writing instruction will be examined. The specific genre for this study is a research paper. Different patterns of instructor-learner interaction in both instructional situations will also be investigated.
There will be three in-person visits for instructions on academic writing. Pre- and Post-instructions questionnaires and reflective journals will be collected.
non-native English speakers
adults older than 18 years old
active student enrolled at University Park campus
living in the United States
younger than 18 years old
not living in the United States
Telehealth Navigation for Informed Prostate Cancer Screening in Black Men
This study is being conducted to determine whether patient navigation improves informed decision making for prostate cancer screening. Participants will be offered the opportunity to discuss and address issues related to PSA testing with a patient navigator over a one month period. Surveys at the beginning and end of this period will include health knowledge, opinions on telehealth, and barriers to health care. All sessions will be conducted virtually.
Complete short on-line questionnairesComplete at least one telehealth session with the Patient Navigator
100
ages 45 to 70
spoken english language
ATHN 10: Leveraging the ATHNdataset to Document the State of RareCoagulation Disorders in the United States
This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).
One tube of blood will be collected during a routine clinic visit.
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset
Understanding experiences of international students with healthcare and antibiotics
This study examines the experiences of international students with regard to upper respiratory illnesses, healthcare, and use of antibiotics in their home countries and in the United States. The findings of the study will inform the development of training to improve healthcare providers’ communication skills for discussing antibiotics with international students.
Complete one online survey, which takes approximately 20 minutes.
10.00
College/university undergraduate or graduate student at a U.S. university
born and raised in and is currently a citizen of China, India, or South Korea
English speaking
lived in the United States for less than 7 years
Not a college or university student at a U.S. university
Not born or raised in and currently citizen of China, India, or South Korea
Not English speaking
Lived in the United States more than 7 years
Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model
This study will test the hypothesize that the combination of low-moderate to severe paresis and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.
There will be two evaluation sessions, 15 training sessions, and 3 post-test evaluation sessions
$2,100
Motor impairment in the arm
Had a stroke confirmed by neurology
Chronic stage of stroke
a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder)
hospital admission for substance abuse
peripheral disorders affecting sensation or movement of the arms,
currently taking prescription drugs with known sedative properties that interfere with sensory-motor function
A PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, NON-INFERIORITY, MULTI-CENTER STUDY OF THE EFFECTS OF STOPPING HYDROXYCHLOROQUINE IN ELDERLY LUPUS DISEASE
This trial will address the safety of withdrawing hydroxychloroquine (HCQ) in patients with systemic lupus erythematous who are 60 years of age or older. In this older population the benefits of HCQ are expected to decrease since disease activity decreases with advancing age. The study will test whether HCQ can be safely discontinued in stable/quiescent patients.
Participants will be in this study for about 1 year, during which time they will come to 7 visits in the research clinic. The first visit will take up to 2 hours and will include blood and urine sampling and completion of self-assessment questionnaires. Subsequent visits will take up to 1 hour. Participants will be randomized to receive either the active drug hydroxychloroquine or placebo. The treatment will be blinded to both the participant and the investigator. Diaries will be requested in which the participant keeps track of dosing of the study medication.
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Effects of heating on exercise pressor reflex in peripheral artery disease: Exercise Ability
To determine if the sympathetic and blood pressure (BP) responses to exercise will be attenuated during and after heat exposure in patients with peripheral artery disease (PAD).
There will be up to 6 visits at the Hershey Medical Center.The visits involve walking on a treadmill, sitting in a warm or neutral temperature bath, wearing a heat suit, and having one or both of your legs in a warm bath.
You will receive $25 per hour for your participation in this research study
all minorities and ethnicies included
free of acute or chronic medical conditions
over 21 years old
under 21 years old
Decisional impairment
PSCI 21-160: A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination with Venetoclax in Adult Patients with Acute Myeloid Leukemia
The purpose of the study is to evaluate the potential interaction between ASTX727 and venetoclax, the study drugs, evaluate the safety when the study drugs are taken together, and any potential benefits of taking the study drugs together.
The study is expected to last about 20 months. The amount of time you will be on study treatment or be followed up for health information as part of the study depends on how you respond to and tolerate the study treatment.Study assessments/procedures will occur during screening, a period in which your eligibility to enter the study is determined, while on treatment, at treatment discontinuation, when you decide to or are taken off the study treatment, and during the safety follow-up period. While in the study you must follow the directions given to you by the study staff. If you do not follow the directions given to you, you may not be able to continue taking part in the study. You must come to the study center for all visits, including the follow-up visit after your last dose of study treatment, unless you are told a telephone call is an acceptable option.
Newly diagnosed AML by World Health Organization (WHO) 2016 criteria
For Phase 1, ECOG 0-2. For Phase 2, ECOG 0-3.
Projected life expectancy of at least 3 months.
Known active hepatitis B or C infection
Known human immunodeficiency virus (HIV) infection
Severe renal impairment
Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
This pilot study seeks to determine if formula feeding recommendations that are adjusted using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants.
There will be 5-7 visits, where you will record formula volumes on diary cards for a total of 6 days per visit, and be given formula volume recommendations if you are in the intervention group. All participants will complete surveys when their infants are 1 and 6 months of age.
$300
Term or Early term Infants (≥37 weeks)
Infant birthweight ≥50th percentile
Normalizing preteen HPV vaccination with practice-based communication strategies (Protect Them)
This study seeks to adapt and test a culturally-relevant, web-based game intervention to motivate Spanish-speaking preteens to initiate and complete human papillomavirus (HPV) vaccination. The present study will adapt an existing web-based game developed as an educational tool on HPV vaccination for English-speaking preteens in North Carolina. The study includes the recruitment of paired dyads (Spanish-speaking preteens and parents) to focus groups to evaluate the acceptability of cultural adaptations to the existing web-based game intervention. We will recruit up to 25 parents and preteens ages 11-12 who will receive a link to the Spanish game to play for 7-10 days in advance of the focus group discussions. The focus groups will ask participants about cultural and language adaptations to the existing game and how they react to a game that will serve as an interactive, educational tool on HPV vaccination. The focus groups will take place in Harrisburg, PA between January and March of 2018. No health information will be collected as part of this study.
Not vaccinated with the HPV vaccine
Have computer, tablet, or smartphone
CC-93538-EE-001 – A PHASE 3, MULTI-CENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS
The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction and inflammation in subjects with Eosinophilic esophagitis (EoE).The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. The phase 3 program will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance, and Open-Label Extension study.
The participants are required to sign the consent form. If you decide to participate, you will be required to attend study visits, follow doctor's instructions and take the study drug as instructed. You will be required to complete electronic questionnsires, and tell you doctor about any health problems, symptoms and drugs that you are taking. There are two visits during screening, including EGD procedure with biopsies. All the procedures during screening are done to determine if you are qualified to participate in the study. If the screening tests show that you can take part in this study, a computer program will make the assignment of which study drug you are to receive. You will be assigned to start the study by receiving either active drug (360 mg of CC-93538), or placebo. Both active drug and placebo will be given weekly by subcutaneous injection.You will be asked to have blood test done for serum and for biomarkers at most of your visits (except week 20). Physical exam and pregnancy's tests will be done at screening visit, and every visit during the induction after week 4. the ECG test will be done at screening. Similarly, the blood work and pregnancy's tests will be done at every visit during the maintenance. urinalysis and physical exam will also be done at some visits in the maintenance. Your vital signs will be monitored throughout the study.
$750 induction, $565 Maintenance max
Histologic evidence of EoE
Symptoms of dysphagia
Previous therapy with PPI medications, intolerant or inadequate corticosteroid response, or steroid responders/naive
Must agree to maintain stable diet
Liver function impairment, structural abnormality of esophagus
Receiving concurrent treatment with another IP, or the same drug previously
Currently is succesfully treated for EoE with dietary modifications
Currently receiving corticosteroids
Children’s reaction to multimodal cues in instructional materials
We aim to study how minoritized students perceive multimodal cues in instructional materials to improve STEM teaching for their STEM identity development.
To participate in the study at Penn State, students will be accompanied with their parent or a legal guardian. During the 40-minute session, participants will be asked to complete a brief survey and take part in an interview.
$50
English is understood by prospective subjects or representatives
English is not understood by prospective subjects or representatives