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VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment
To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for Acute Respiratory Distress Syndrome (ARDS) and mortality.
Vit. D deficiency
blood Calcium levels > 10.2
known kidney stone in past 1 year
Do Not Rescusitate orders (DNR)
A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.
Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.
You will receive either study drug or placebo, undergo research-related tests and procedures, and questionnaires. You will need to visit the study center up to 18 times over a period of 15 months. You will have different tests and procedures throughout the study. The aim is to check on your health andsymptoms, check on your response to treatment and any side effects, and assess the study drug.This study will compare the study drug with either mepolizumab or benralizumab, known as the comparator medications. The effects of the drugs, both good and bad, will be compared. Study participants will be divided into 2 groups to receive:Study drug (once every 26 weeks) + placebo (once every 4 or 8 weeks) OR,Mepolizumab (once every 4 weeks) or benralizumab (once every 8 weeks) + placebo (once every 26 weeks).All participants will receive an active treatment. You will be assigned to receive either the study drug or comparator (mepolizumab or benralizumab) you were taking before the study. No participant previouslytaking mepolizumab will be assigned to benralizumab, and no participant previously taking benralizumab will be assigned to mepolizumab.
Have a documented diagnosis of asthma for 2 or more years.
Receiving either mepolizumab or benralizumab for 12 or more months prior to screening.
A well-documented requirement for regular treatment with medium to high dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroid.
Current treatment with at least one additional controller medication, besides an inhaled corticosteroids.
Current or former smokers with a smoking history of 10 or more years.
Active COVID-19 infection
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
A phase 3 clinical trial to investigate the effectiveness and safety of a study drug in subjects in Idiopathic Pulmonary Fibrosis
You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.
Diagnosed with Idiopathic Pulmonary Fibrosis
Female participants who are pregnant or lactating
Receiving more than 10 L/min of oxygen supplementation at rest
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.
Participants from Europe or European Union (EU)
Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey
The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.
Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.
Depends on study
Current tobacco user
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.
Books a medical appointment for upper respiratory tract infection
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
Translational Studies on Electronic Cigarette-derived Oxidants and their Long-term Cardiopulmonary Effects
This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD
You will be asked to reduce your cigarette smoking and use study-provided e-cigarettes for 3 months. You will be asked to attend 2 in-person visits at the Hershey Medical Center and participate in 4 telephone visits. Throughout the study you will be asked to complete questionnaires, have heart rate, blood pressure and pulse oximetry taken, electrocardiograms (ECGs), height and weight measured, provide medical history, perform pulmonary function tests, complete a 6-minute walk, have your exhaled carbon monoxide measured, provide urine specimen and have blood drawn.
current use of other tobacco products
allergic to vegetable glycerin and/or propylene glycol
chronic drug and/or alcohol abuse
A 52-week, randomised, double-blind, placebo-controlled, parallel group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilicphenotype
Placebo-controlled efficacy and safety study of GSK3511294 in participants with severe asthma with an eosinophilic phenotype
There will be 19 in person visits over the course of 15 months where blood, EKGs, and other assessments will occur. You will receive the study drug every 26 weeks.
Have, or a high likelihood of having eosinophilic asthma
Have at least 2 asthma attacks requiring steroids in the past 12 months
Take daily inhaled corticosteroids
Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within the last 12 months
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within last 130 days prior
Current smoker or history of smoking
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis
This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis
-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety andEfficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 Clinical Trial to assess whether study drug DWN12088 is safe and effective in Patients With Idiopathic Pulmonary Fibrosis
During this study, you will be asked to come to in-person visits at the Hershey Medical Center over a period of 6 months During that time you will visit the study center 8 times and have various tests done including: signing informed consent, providing demographics, having a chest CT scan, reviewing medical history, having a physical exam done, having vital signs and an ECG taken, having bloodwork done, receiving study drug, receiving patient diaries, having study drug administered, performing lung function tests (spirometry, DLCO and 6-minute walk test), and completing questionnaires.
Diagnosed with idiopathic pulmonary fibrosis in the past 5 years
Able to walk 150 meters (492 feet) in 6 minutes
Lower respiratory tract infections requiring antibiotics in the last 4 weeks
Female participants who are pregnant or nursing
Use of investigational drugs for idiopathic pulmonary fibrosis in the last 4 weeks
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
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
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