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Search Results Within Category "Infectious Diseases & Immune System"

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19 Study Matches

Visceral Pain Sensation and Nav1.8

We wish to investigate the role of a specific gene in visceral pain sensation and perception. This gene, Nav1.8 has a known change present in 10% of the population which may affect the way we feel inflammatory pain in the gut. This is an important symptom in inflammatory bowel disease (IBD). Some patients feel high levels of pain we would like to control, other patients feel little to no pain in the presence of very active disease, which can lead to dangerously under-treated disease. In this study, we will use healthy volunteers as well as IBD patients, and test their sensitivity using rectal balloon dilation.Research subjects will be asked to fast, skipping solid foods and opaque liquids for 6 hours before the testing. Usually this means skipping 1 meal. At the beginning of the study visit. they will use an over the counter enema to clear their rectum of any stool. Healthy control subjects that have never had a colonoscopy before and all IBD patients will undergo a very brief proctoscopy to either verify rectal health or check for any IBD disease activity. Healthy controls that have had a prior colonoscopy within the last 5 years will skip that prior step. Then a trained physician on the research team will insert a thin, lubricated tube into the rectum, which will be inflated to specific pressures. Most of these tests will be designed to measure any change in sensation, then the need to use the toilet, followed by urgent need or discomfort, and lastly the lower threshold of pain. Test subjects will be able to stop testing at any time, should they become too uncomfortable. The testing takes between 1 and 1 and a half hours, and volunteers are compensated $200 for their time.

To simulate abdominal pain, we use a thin tube placed in the rectum that inflates a small balloon to very precise and safe pressures. Our bodies interpret these pressures (in ascending order) as the need to go to the bathroom; first just a little, then with increasing urgency and eventually discomfort and pain. During these experiments, we only measure the lower threshold of pain, and stop immediately when you tell us to stop. We have significant experience using this approach and we have found it consistently informative while causing the least amount of discomfort possible. The whole thing takes about an hour and we’re paying volunteers $200 for participating. We'll ask that you skip a meal before the study visit, and perform an over-the-counter enema at the start of the visit.

$200

Yes
 

Matthew Coates
August Stuart - at astuart@pennstatehealth.psu.edu or 717-531-0003, ext=281928
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010688
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Inclusion Criteria:
Have a diagnosis of ulcerative colitis, Crohn's disease, or no lower GI diseases (healthy control)
UC and Crohn's patients: be willing to undergo a brief proctoscopy the day of the testing visit
Healthy controls: have had a colonoscopy in the last 5 years OR be willing to undergo a brief proctoscopy the day of the testing visit

Exclusion Criteria:
UC and Crohn's patients: moderate to severe disease activity on your recent colonoscopy
Healthy control: any diagnosed lower GI disease (such as IBS or active diverticulitis) or significant abdominal pain in the last 12 months.
Any peripheral neuropathy or neuromodulating/opioid medications
Any Autoimmune disease (except Crohn's disease or ulcerative colitis)
Infectious Diseases & Immune System, Digestive Systems & Liver Disease, Pain Management
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Hershey, PA ,
State College, PA ,

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Restrictive (vs liberal) fluid treatment strategy during the first 24 hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital mortality.

Yes
 

Lawrence Kass
Nancy Campbell RN - at ncampbell1@pennstatehealth.psu.edu or 717-531-1707, ext=3
Emergency Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00343402
SITE00000005
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Inclusion Criteria:
Age > 18 years
Suspected or confirmed infection
Sepsis induced hypotension

Exclusion Criteria:
> 4 hours from start of hypotension
> 3 L intravenous fluids
Pregnancy
Severe volume depletion
Immediate surgical intervention planned
Infectious Diseases & Immune System, Heart & Vascular
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Hershey, PA ,

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.

Yes
 

DAVID INGRAM
David Ingram - at dingram@pennstatehealth.psu.edu or 717-531-8881
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011530
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Inclusion Criteria:
Healthy
18 years or older

Exclusion Criteria:
Active Cancer
History of having your spleen removed
History of liver or kidney disease
HIV
Diabetes
Infectious Diseases & Immune System
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Hershey, PA ,
Reading, PA ,
Wilkes-Barre/Scranton Area, PA ,

Understanding healthcare workers perception and knowledge of dysphagia

The purpose of this study is to gain a greater understanding of healthcare workers’ knowledge of and perception of dysphagia in older adults. Study participants will fill out a survey/questionnaire in a single study session. This is expected to take 15-20 minutes.

You will be asked to complete a single, brief survey. It will take no more than 15-20 minutes.

No
 

Aarthi Madhavan
Aarthi Madhavan - at aarthi@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00024236
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Inclusion Criteria:
Age 18 and older
Active healthcare workers or care providers for community dwelling older adults over 60 years old
Working with older adults
English proficiency at 8th grade level

Exclusion Criteria:
Never worked with older adults
Not working clinically currently
Diagnosed mild cognitive impairment or dementia
Infectious Diseases & Immune System, Food & Nutrition, Prevention
Not applicable
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Depressive Symptomatology and Inflammation

The purpose of this research is to investigate the associations between depressive symptoms and inflammation. The researchers are studying how specific symptoms of depression (such as fatigue, sadness, impaired concentration, and loss of pleasure) are related to markers of inflammation, which is a key component of our immune system. Volunteers with depressive symptoms, as well as volunteers without depressive symptoms are needed for this research study. This study includes an online survey to determine eligibility and one in-lab visit. Participants who are eligible will be scheduled for one in-lab visit (2.5-3h for participants with depressive symptoms & 1-2h for participants without depressive symptoms), where they will be asked to answer surveys with questions related to depressive symptoms and complete a number of tasks (using an iPad and a touch screen phone) that measure thinking skills including attention, memory and reaction time. Participants will also undergo a single blood draw to assess inflammatory markers.

Participation will require one in person visit at the CRC that takes from 1 to 1.5 hours total where they will have their blood drawn, fill out surveys about their mood, and complete cognitive tests.

30

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011171
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Inclusion Criteria:
Fluent in English
No history of depression
Free of chronic inflammatory or autoimmune disorders
If female, not pregnant or nursing

Exclusion Criteria:
Personal or family history (first-degree relatives) of major depressive disorder or major psychiatric illness
Taking non-steroidal anti-inflammatory agents or statins everyday within the past month
Taking antipsychotics or mood stabilizers
If female, are post-menopausal or pregnancy/lactation
Infectious Diseases & Immune System, Mental & Behavioral Health
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State College, PA ,

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

No
 

Erina Farrell
Erina Farrell - at elm26@psu.edu
Communication Arts and Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021922
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Inclusion Criteria:
18 years of age or older
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

Exclusion Criteria:
Less than 18 years of age
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
Infectious Diseases & Immune System
Not applicable
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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.

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 NOT accepting healthy volunteers
NCT05799378
SITE00001380
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Inclusion Criteria:
Have a diagnosis of systemic lupus
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares

Exclusion Criteria:
abnormal eye exam related to use of hydroxychloroquine
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Infectious Diseases & Immune System, Arthritis & Rheumatic Diseases
Not applicable
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Hershey, PA ,

A Phase 1/2, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of BMN 331, an Adeno-Associated Virus (AAV) Vector-Mediated Gene Transfer of Human SERPING1, in Subjects with Hereditary Angioedema (HAE) due to Human C1 Esterase Inhibitor (C1-INH) Deficiency

BMN 331 is an experimental drug that is being tested for the treatment of patients with HAE. This study is the first time BMN 331, which is a gene therapy, is being used in humans. BMN 331 is given only once during this research study and it is given as an infusion. The purpose of this study is to find out what effects, good and/or bad, the Study Drug has on you and your HAE.

You will have a total of 68 in person visits over 68 months where there will be blood drawn and other lab tests. You will have to travel to an off site location to receive the drug once and travel will be paid for by the sponsor of the trial.

Yes
 

Timothy Craig
Hunter Smith - at hsmith16@pennstatehealth.psu.edu
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05121376
STUDY00019539
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Inclusion Criteria:
Male or Female, 18 years of age or older
Have a diagnosis of Hereditary Angioedema type I or type II
Willing to abstain from alcohol consumption for 52 weeks after the infusion
Females of childbearing potential must be willing to use contraception

Exclusion Criteria:
Evidence of active or chronic infection, including Covid-19, or any immunosuppressive disorder
Active cancer, autoimmune, hematologic, cardiac, or renal diseases which require regular treatment
Long term use of attenuated androgens
using immunosuppressants including corticosteroids
Infectious Diseases & Immune System, Allergies
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Hershey, PA ,

Threat of infection, social decision-making, and the autonomic nervous system

The purpose of the study is to test how social decisions are affected by possible risk of infection. We aim to examine how choices in a risky social decision-making situation can influenced by viewing images of infection threat (e.g., person with runny nose) vs. images of neutral scenes or other threatening scenes.

There will be one 90-minute in-person visit. Participants will be asked to have electrodes placed on their skin to record their physiological signals, answer questionnaires, and complete a decision-making task on the computer while looking at different images.

$30

Yes
 

Derek Spangler
Eva Li - at eql5351@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019072
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Inclusion Criteria:
Adult over 18 years of age
Student at Penn State University Park
English-speaking
No cardiovascular, metabolic, or neurological condition
No diagnosis of COVID-19 within the last 14 days

Exclusion Criteria:
Under the age of 18
Not a student at Penn State University Park
Does not speak English
Has cardiovascular, metabolic, or neurological condition
Has/had diagnosis of COVID-19 within the last 14 days
Infectious Diseases & Immune System, COVID-19, Heart & Vascular
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State College, PA ,

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROL, PARALLEL GROUP STUDY TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND SAFETY OF INBRX-101 COMPARED TO PLASMA DERIVED ALPHA1-PROTEINASE INHIBITOR (A1PI) AUGMENTATION THERAPY IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA

Voluntary research study is to test INBRX-101 as an experimental drug to treat patients with alpha-1 antitrypsin deficiency. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in AATD emphysema patients when compared with current approved AATD therapy with A1PI.

You will visit the study site up to a total of 37 times for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion.

Unknown at this time

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05856331
STUDY00022890
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Inclusion Criteria:
Males or females 18-80 years of age and Ability to understand and the willingness to sign a written informed consent document
Confirmed diagnosis of alpha-1 antitrypsin deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Available to participate for duration of study and willingness to commit to all requirements of the study, including study visits

Exclusion Criteria:
Known selective or severe Immunoglobulin A (IgA) deficiency
On waiting list for lung or liver transplant
Known or suspected diagnosis of type 1 diabetes or diagnosed uncontrolled type 2 diabetes
Active cancers or has a history of cancer within 5 years prior to screening
Females who are pregnant or breastfeeding or females of childbearing potential unwilling to practice highly effective contraception during the study
Infectious Diseases & Immune System, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

Study of Angelica gigas dietary supplements (Cogni.Q) and potential effects on human immune cells

This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. We had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.Approximately 40 men will take part in this research study at Hershey Medical Center.

Yes
 

Junxuan Lu
Deepkamal Karelia - at dkarelia@pennstatehealth.psu.edu or 717-531-0003, ext=285476
Pharmacology (HERSHEY)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00008009
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Inclusion Criteria:
Male subjects 21 to 65 years of age
Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19=< BMI >=30
Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR).
Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)

Exclusion Criteria:
Subjects positive for HIV, HBV and HCV (self-reported)
Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded.
Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study.
Non-English-speaking subjects
Infectious Diseases & Immune System, Blood Disorders, Food & Nutrition
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Hershey, PA ,

Effects of antibiotic use on fecal microbiome and resistome

This study will investigate the changes in the human fecal microbiomes and resistomes in response to antibiotic treatment.

No
 

Jasna Kovac
Jasna Kovac - at jzk303@psu.edu or 814-699-1680
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011756
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Inclusion Criteria:
over age 18
English speaking/reading
Books a medical appointment for upper respiratory tract infection

Exclusion Criteria:
Patient took antibiotics in the past week
Patient participated in STUDY00012891 previously
Reason for medical visit is not upper respiratory tract infection
Patient is pregnant
Patient has a medical history that includes diagnosis of any intestinal related disease
Infectious Diseases & Immune System, Lung Disease & Asthma
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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 ,

Saliva microRNA signatures in infants with wheezing associated respiratory illness

Wheezing is a common symptom of respiratory distress in infants and children. Infants who wheeze are at increased risk of being diagnosed with asthma, the most common chronic disease of childhood. This study aims to yield an objective measure of asthma risk using molecular markers obtained from saliva. Saliva miRNA (markers used in this study) levels will be measured using HiSeq technology. Refinement and validation of this measure in future large-scale studies could allow clinicians to accurately predict for families an infant’s risk of asthma and optimize medical management to prevent future hospitalizations.

If your child has a respiratory illness you will be asked to provide a saliva sample at one clinic visit. Six months after the initial encounter, you will be asked to do complete surveys designed to be done remotely at home.

$20.00

Yes
 

Steven Hicks
Courtney Byrnes-Rumbaugh - at cbyrnes@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: General Pediatrics (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00018136
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Inclusion Criteria:
Less than or equal to 12 months of age
Presence of respiratory illness symptoms (cough, congestion, shortness of breath, runny nose)

Exclusion Criteria:
Congenital lower respiratory tract malformation or anomalies
Concurrent pneumonia (bacterial lung infection) at the time of enrollment
Bronchopulmonary dysplasia
Concurrent bacterial infection requiring antibiotics (e.g. otitis media)
Infectious Diseases & Immune System, Children's Health, Allergies
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Hershey, PA ,

A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic

We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.

No
 

Pritish Mondal
Pritish Mondal - at pmondal@pennstatehealth.psu.edu or 717-897-0652
Pediatrics: Allergy and Immunology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015136
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Inclusion Criteria:
General population
Adult

Exclusion Criteria:
Age below 18 years
Mentally impaired
Participants from Europe or European Union (EU)
Infectious Diseases & Immune System, Prevention, Lung Disease & Asthma
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SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial

Adults recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, we are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load amongst adults.

At their home, participants will perform three nasal and oral rinses per day for 4 days and self-swab the nose and mouth before and after each morning rinse to collect specimens under the guidance of a zoom visit. On the morning of the 5th day participants will also self swab the nose and mouth for a final collection specimen. Participants will answer questions on an app and online platform.

100

Yes
 

Rena Kass
Dee Bagshaw - at ddm108@psu.edu or 814-863-7126
Surgery: General Surgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04802408
STUDY00016947
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Inclusion Criteria:
18 years of age or older
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation

Exclusion Criteria:
History of nasal or sinus surgery
Non-English speaking
Lack of electronic device (computer, mobile phone etc) on which to access an app for study data collection
Adults that need inpatient care for COVID-19 or any of its complications
Adults that give a history of being unable to tolerate gargles or nasal washes
Infectious Diseases & Immune System, COVID-19, Prevention
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Harrisburg, PA ,
Hershey, PA ,
State College, PA ,

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312(Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

This phase 3b study will evaluate long-term safety and efficacy ofCSL312 (also known as garadacimab) when administeredsubcutaneously (SC) once monthly for at least 12 months.Subjects entering CSL312_3002 will be from 3 sources:• Subjects who participated in Study CSL312_2001• Subjects who participated in Study CSL312_3001• CSL312-naïve HAE subjects who have not participated ineither of the above studies

During the study, you will be expected to self-administer the study medication by injection under the skin once a month, complete a daily diary, provide blood and urine samples, complete questionnaires, undergo physical exams and have your vital signs recorded.You will visit the site 12 times.

$80.00 plus travel reimbursement

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04739059
STUDY00017906
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Inclusion Criteria:
Able to understand and provide informed consent
Male or female
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening, as documented in the subject's medical record.
Aged ≥ 12 at the time of providing written informed consent or assent for minors

Exclusion Criteria:
Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period.
Use of mAbs such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects’ use of estrogen-containing medications with systemic absorption (eg, oral contraceptive or hormonal replacement therapy within 4 weeks prior to the Run-in Period).
Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 3 months after receipt of the last dose of CSL312.
Infectious Diseases & Immune System
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Hershey, PA ,

A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants with Hereditary Angioedema (The ALPHA-STAR Trial)

The main purpose of the study is to evaluate the safety and tolerability of an injection of the study drug in participants with Hereditary Angioedema. This study is open-label, which means that everyone in the study will receive the study drug and no participant will receive a placebo.

The study will last approximately for one year, with a total of approximately 11-16 study site visits. You will have your blood drawn at every study site visit, urine collected, pregnancy test if applicable, and receive study drug. You will also complete questionnaires and be contact weekly by the study site.

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
NCT05695248
STUDY00022131
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Inclusion Criteria:
At least 18 years of age.
Documented diagnosis of HAE type I or II.
Experienced at least 4 HAE attacks within the 12 months prior to screening.
Negative pregnancy test at screening visit
Experience at least 2 HAE attacks during the Run-In period.

Exclusion Criteria:
Any use of androgens
Active liver disease
History of drug or alcohol abuse in the 12 months prior to screening
Pregnant or breastfeeding
Use of medications prescribed for the prevention of HAE attacks prior to screening: lanadelumab within 90 days, berotralstat within 21 days, all other prophylactice therapies within 7 days.
Infectious Diseases & Immune System
Not applicable
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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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Study Locations

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Location Contacts
Hershey, PA ,