Search Results
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.
Adult
Mentally impaired
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.
English speaking/reading
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
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
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 eosinophilic phenotype
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
PSCI 21-064: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer.
A study designed to evaluate the efficacy and safety of BGB-A1217 + tislelizumab compared with that of pembrolizumab in patients with PD-L1-selected NSCLC who have locally advanced or recurrent disease that is unresectable or not amenable to radiotherapy, with or without chemoradiotherapy, or previously untreated metastatic disease, and whose tumors do not harbor EGFR-sensitizing mutations or ALK translocations. The efficacy and safety of tislelizumab alone will be explored in a small cohort of the same patient population.
You will have the following exams, tests, or procedures done: Measurement of your height, weight, and vital signs (blood pressure, respiratory rate, pulse, and temperature) Complete physical exam Blood sample collection for the following tests: Safety laboratory tests. This may include routine tests and special blood chemistries, blood clotting, and blood counts to evaluate your overall health and thyroid, liver, pancreas, and kidney, and heart functions. Additional blood samples may be collected to perform routine blood tests, if your study doctor thinks it is necessary. Enzymes tests to check your muscle and heart function (Creatine kinase [CK] and creatine kinase muscle/brain [CK MB] isoenzyme or Troponin I or Troponin T) You will be tested for HIV, Hepatitis B virus and hepatitis C virus to check whether you are infected with these viruses. If a test shows that you have an active hepatitis B or C infection or HIV, you will have follow-up counselling and medical advice provided by the study doctor or study staff. If your test results are positive, you will be notified and the study doctor will be required by law to notify government health authorities. Signing this consent form means that you agree to have this testing. Urine sample collection for routine safety tests. If you are a woman and are able to become pregnant, you will have a urine or serum pregnancy test (must be negative to enter the study). An electrocardiogram (ECG) to look at the electrical activity of your heart. Pulmonary function test to check how your lungs are working and completion of questionnaires about your general health, well-being, and overall quality of life. Imaging to assess your tumor before starting treatment. A computerized series of x-rays (CT scan or Computed Tomography) will be performed. A series of pictures of the inside of your body created by magnetic energy (MRI scan or magnetic resonance imaging) may be done if a CT scan is not available or if this is considered a more appropriate test for your cancer by the study doctor. In addition, an MRI or CT of the head will be done to determine if there is any spread of the cancer to your brain. A type of imaging that uses a radioactive substance called tracer to look at your body (whole-body positron emission tomography (PET)/CT scan) or a bone scan may also be performed if your study doctor decides to do so. Rarely, color photography may be used to document skin metastases if you have any.
Age ≥ 18 years on the day of signing the informed consent form
Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic nonsquamous or squamous NSCLC.
ECOG Performance Status ≤ 1.
At least 1 measurable lesion as defined per RECIST v1.1.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis
Patients with active hepatitis C.
Known history of HIV infection.
A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE)
This study involves the use of a new medicine known as ISIS 721744 as a new treatment for Hereditary Angioedema, which is designed to lower the amount of a protein, known as prekallikrein (PKK), which is made by your liver. When PKK is made by the liver and released into your blood stream, it can lead to Hereditary Angioedema attacks. Therefore, the purpose of this study is to assess if reducing the amount of PKK can reduce your HAE attacks and to see how safe ISIS 721744 is for patients with HAE.
There will be 11 in-person visits over 11 months that you will need to come to where there will be blood drawn, as well as other assesments. You will receive and injection of the study drug once a month.
Must have a documented diagnosis of Hereditary Angioedema Type 1 or 2
Experience a minimum of 2 attacks during the screening period
Females must refrain from becoming pregnant for the duration of the study
A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II
This research study will test an investigational medication called KVD900, a new oral drug being developed to treat hereditary angioedema, the same condition you have. This study is being done to understand how well one or two doses of KVD900 300mg or KVD900 600mg works against placebo to bring relief from an attack of HAE.
If you decide to take part in the study, you will come to the site for 2 visits, and you will have 4 televisits, which may be done by phone or video. Your participation in the study will be approximately 25 weeks. You will need to complete a study e-diary that will use an app that will be downloaded onto your personal mobile device, or on a mobile device provided to you for the purpose of this study. We will perform vital signs, a physical exam, an electrocardiogram (ECG), pregnancy test, and blood collection. In this study every patient will treat one attack with 300mg of study drug, one attack with 600mg of study drug, and one attack with placebo. If after 3 hours following your first dose of study drug you do not experience the needed relief, your assigned kit includes a second dose of study drug that you may take for the attack. The second dose is the same treatment as the first dose. If after 1 hour of your second dose of study drug you do not experience the needed relief, you may dose with your conventional medication.
Up to $1,050
Confirmed diagnosis of HAE type I or II at any time in the medical history.
Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative must also provide signed informed consent when required.
Patients must be able to swallow trial tablets whole.
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
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 one year. You will be asked to attend 5 in-person visits at the Hershey Medical Center and participate in 10 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.
mild-moderate COPD
current smoker
current use of other tobacco products
allergic to vegetable glycerin and/or propylene glycol
chronic drug and/or alcohol abuse
A Phase II, Double-blind, Placebo-controlled, Randomized, Dose ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II)
PHVS416 (PHA-022121 soft capsules) is being developed for the treatment of HAE. The main purpose of this research study is to test the effectiveness of different doses of study drug in preventing HAE attacks. Within this study, PHVS416 will be compared to a placebo.
Diagnosis of Heriditary Angioedema Type I or II
Must have had at least 3 HAE Attacks in 3 Months, or 2 HAE attacks in 2 months during screening period
Females must be willing to use highly effective contraception for the duration of the trial
Participation in any other clinical trial in the 30 days prior to enrollment
Currently receiving any other prophylactic treatment for HAE and unwillingly to stop current medication
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
This study is being done to study the efficacy of KVD824 as prophylaxis treatment for attacks of HAE (meaning whether or not it works to prevent the occurrence of attacks) in your body. KalVista has designed this study to understand the effect of KVD824 at 3 different dose levels and investigate more about how safe KVD824 is (to find out what effects - good and bad - KVD824 has) when compared with a placebo. Placebo looks like KVD824 but contains no active drug.
The study has a “Screening Period” that starts with a Screening Visit and follows with a “Run-In”-; a Randomization Visit; and a “Treatment period” ending with the End of Treatment Visit. You will have approximately 6 study appointments or “visits” where different procedures will take place such as blood draws, ekg's, and physical exams.
Confirmed diagnosis of HAE type I or II
Access and ability to use conventional treatment for HAE attacks
Subject is willing to cease any current medications being taken for HAE treatment
Female subjects must agree to use at least one highly effective contraception method from screening visit until end of trial
Use of ACE inhibitors after the Screening Visit or within 7 days prior to randomization.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) after the Screening Visit or within 7 days prior to randomization.
Any pregnant or breastfeeding subject.
Prevalence of Avoidant Restrictive Food Intake Disorder (ARFID) traits among children and adolescents with Food Allergy
This study looks at understanding eating behaviors and attitudes toward food in children/adolescents. More specifically the study's goal is to compare those with and without food allergies to gain a better understanding of a possible underlying factor towards certain behaviors. Children and their caregivers will complete a survey composed of a short section on the child's medical history regarding allergies followed with questions in commonly used clinical assessments.
Age 18 years or older
Intellectual disability preventing comprehension of questions
Child and/or caregiver unable to respond to English-language questionnaire
Site For VIOLET
Site For VIOLET
shock
sepsis
pancreatitis
Vit. D deficiency
blood Calcium levels > 10.2
known kidney stone in past 1 year
Do Not Rescusitate orders (DNR)
prisoner
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 and symptoms, 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 previously taking mepolizumab will be assigned to benralizumab, and no participant previously taking benralizumab will be assigned to mepolizumab.
$183.00
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.
Eosinophilic diseases
Pregnancy
Current or former smokers with a smoking history of 10 or more years.
Active COVID-19 infection
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 will 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
Presence of respiratory illness symptoms (cough, congestion, shortness of breath, runny nose)
Concurrent pneumonia (bacterial lung infection) at the time of enrollment
Ongoing use of steroids (inhaled or oral)
Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
A study to evaluate the effectiveness and safety of the study drug Pamrevlumab (FG-3019) in participants with Idiopathic Pulmonary Fibrosis (IPF)
During this study, you will be asked to come to in-person visits at the Hershey Medical Center every 3 weeks for a total of 48 weeks. 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, receive study drug infusions, have physical exams, perform pulmonary function tests, have blood drawn and get CT (computed tomography) scans.
Diagnosed with IPF in the past 7 years
Not currently taking pirfenidone or nintedanib
Smoking within 3 months of screening/unwilling to avoid smoking throughout the study
Female participants who are pregnant or nursing
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 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.
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
Active cancer, autoimmune, hematologic, cardiac, or renal diseases which require regular treatment
Long term use of attenuated androgens
using immunosuppressants including corticosteroids