Search Results
Exploratory Trial of Ruxolitinib 1.5% Cream for Early Stage Hidradenitis Suppurativa
Explore all stages of Hidradenitis Suppurativa with a topical medication.
There will be 7 in-person visits and 1 follow-up phone call over a 33 week period. Over the course of the study, the following study procedures will take place: medical history and medication history collection, ECG, lab tests (both blood and urine), photography, skin exams, physical exams, questionnaires, and skin biopsies.
Up to $350
Must have active HS in at least 1 area
Must have negative TB screening assessment
Certain medications can be continued if on stable dose; study coordinator will discuss further.
Pregnant (or considering becoming pregnant) or lactating females
Does not have reliable internet access for weekly electronic surveys
Implementation of a Transcutaneous CO2 Monitoring (ITCOM) Study in ALS
Amyotrophic lateral sclerosis (ALS) leads to respiratory failure due to chronic hypoventilation. The gold standard for measuring hypoventilationrequires an arterial blood gas, which is impractical in the outpatient setting due to invasiveness, pain, and need for specialized equipment. Recently, the Penn State Health Hershey ALS Clinic has implemented transcutaneous CO2 (TCO2) monitoring as standard of care clinical assessment. The overall goals of this study are to gather critical preliminary data for stakeholder-driven refinement of a TCO2 monitoring protocol within a busy ALS clinic and identify how TCO2 may enhance our understanding of standard respiratory measurements.
Participants will complete a survey related to their experience having their CO2 reading performed in the ALS Clinic.
$20 will be paid for every survey completed, for a maximum possible payment of $80 per person.
18 years of age or older.
Seated forced vital capacity (FVC) of less than 100% predicted normal.
Use of any type of non-invasive ventilation, except in the case of continuous positive airway pressure (CPAP) for obstructive sleep apnea
Use of diaphragm pacer
Use of a tracheostomy
In hospice or in active transition to hospice
Young Children’s Representations of Parent-Child Negotiation
The goal of this study is to learn how young children think and tell stories about challenges between parents and children. Children will play games and tell stories using toys while caregivers fill out surveys and talk to researchers. This will occur twice, about 6 months apart. Qualities of children's stories, their language and regulation skills, demographic information about children and caregivers, and parenting behaviors will be examined.
At least one caregiver of a child between ages 5 and 7
English-speaking
Middle income
Caregiver at least 18 years old
Children that are not fluent in English
Children who are unable to tell stories with a researcher due to developmental disability or language delay
Children who are younger than 5 or older than 7
Low or high income
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, willprospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatallythrough age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmfulas well as protective environmental factors. These include prenatal substance use, mental health, stress,sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is tounderstand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will befollowed for 10 years.
If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.
$1,350
Speaks English or Spanish
Does not speak English or Spanish
Exploring Parental Influence in Youth Disability Sport Participation
We are conducting an online survey study for parents of children with disabilities that explores their perceptions of participation in disability sport within their communities.
has a child that is enrolled in a disability or adapted sport program
has a child between the ages of 10 and 17
does not have a child with a disability between the ages of 10 and 17
does not have a child that plays a disability or adapted sport
Testing the Risk Preferences of Engineering Students under Conditions of Limited Information, Sleep, Optimism, and Time Constraints
This is a study that will examine how engineers make decisions under certain conditions and the factors that drive these decisions. The game will be used to simulate different engineering scenarios. All you need to do is play an online game with 3 different scenarios and choose what you feel is the better design based on the available information.
Over 18 years old
Speaks English
Graduate Students
Non-Engineering Majors
A Second Intermediate Expanded Access Protocol for AmyotrophicLateral Sclerosis with CNM-Au8
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 300 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 48-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Able to understand and give written informed consent.
Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.
Participant has a history of any clinically significant or unstable medical condition (other than ALS) that may interfere with assessment of safety or compromise the study objectives.
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Understanding the Well-being of Advanced Counseling Students of Color
The primary objective of this study is to increase our understanding of the ways in which perceived discrimination, coping strategies, competence, stress, social support, and self-efficacy in counselor education programs relate to overall well-being for advanced counseling students of color.
18 years of age or older
Capable of providing informed consent without the assistance of a legal guardian
Identify as a racial or ethnic minority
Able to understand written and spoken English at the time of the survey
Individuals who are not yet adults (infants, children, teenagers)
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC).
this is a phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with Primary Sclerosing Cholangitis (PSC), and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period (no placebo) to assess long-term safety and maintenance of effects of elafibranor.After the first dose of the study intervention on Day 1, the participants will have study visits every 4 weeks through Week 12 of the DBP to assess efficacy and safety. In the OLE period, the study visits for each participant will occur after 4 weeks of entering the OLE, then every 12 weeks up to Week 52, followed by every 22 weeks up to Week 96 which will be the end of treatment (EOT). All participants will have a safety follow-up 4 weeks after the last dose of study intervention.
There will be 2 screening visits followed by 4 visits during the double blind/placebo part of the trial, followed by visits every 3 months for the open label part of the study. All visits will be in person. Blood will be drawn at every visit. Urine will be collected at most visits. ECG's (recording of your heart activity) will be done on a regular basis. Additional procedures include fibroscans (scan of your liver to determine liver stiffness) and ultrasound exams of your abdomen and bladder. Multiple questionnaires will be competed throughout the trial period.
Elevated ALP
percutaneous drain or bile duct stent
cholangiocarcinoma
bacterial cholangitis within 60 days
hepatic decompensation
Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.
We are asking you to give permission for your doctor to send your stored tumor tissue sample for cancer genetic analysis. As part of your cancer care, your doctor may have already collected a tumor tissue biopsy sample (of your cancer tissue) in the past, recently, or being planned as part of standard medical care. Your doctor will ask for any of your stored or available tumor tissue sample collected elsewhere from previous doctors you may have seen in the past. We will not ask you to undergo a new tissue biopsy procedure for this testing however your treating physician may decide to do so as part of your standard of care.There is no required visit for this testing. Once you have signed this consent, your available tumor tissue sample from a prior biopsy or surgery along with the pathology report will be sent to an accredited and certified external genetic laboratory (such as Caris Life Sciences or Interpace Pharma Solutions) to test and understand your cancer’s genetic make-up. The use of your tumor tissue samples as described in this form is necessary for the genetic testing. Without your consent to test your samples, the genetic testing cannot be performed. Once you agree to provide your samples, they cannot be returned to your doctor’s clinic. If the genetic testing of your samples show you have c-MET genetic dysregulations in your cancer, your doctor will discuss your treatment options including clinical trials, such as the APL-101-01 SPARTA trial, with you. If you are interested in participating, you will be asked to review and sign another participant information and informed consent form for the clinical trial before undergoing further screening tests to confirm if you are eligible to participate. The genetic results could also be used to help your clinic doctor decide on an approved therapy, or other investigational therapies that may be right for your specific cancer genetic alterations.
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
PSCI 23-145 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
This trial is comparing two different therapies for the treatment of newly diagnosed multiple myeloma who are not having a bone marrow transplant.
Subjects will be required to keep all research visits, take medications as directed, report any new medication of side effects to the study team,
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
Patient must agree to register to the mandatory Celgene Revlimid REMS program and be willing and able to comply with the requirements of the Revlimid REMS program.
Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.31
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
Patient must not have peripheral neuropathy ≥ Grade 2 on clinical examination or grade 1 with pain
Testing the effect of ENDS flavors on Neurotransmission
Tobacco users will be randomized to use electronic cigarettes containing varying levels of nicotine and flavor during laboratory protocols to investigate the effects on the brain and behavior. Subjects will complete surveys, functional magnetic resonance imaging scans, and complete computerized tasks. Eligible participants include daily users of inhaled tobacco products who are at least 21 years old, able to read and write in English, and not planning to quit tobacco use within the next month. Exclusion criteria include: current substance use impairing participation, unstable or significant medical conditions, current use of smoking cessation medication, uncontrolled serious mental illness, and MRI safety or neurological contraindications.
Subjects will taste test a variety of e-cigarette flavorings, answer questions and complete a single MRI.
50
No plan to quit tobacco use in the next month
Age 21 or older
Able to read and write in English
Unstable or Significant Medical Conditions
Uncontrolled serious mental illness
Current substance abuse
PSCI# 18-127 EA6174 Adjuvant MK-3475 to SOC
The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.
We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
The opioid epidemic among Pennsylvania immigrants: Insights from prescribers and rehabilitation professionals
We will interview prescribers and rehabilitation professionals who have provided services and treatment to immigrants in PA with a history of opioid abuse. The goal is to highlight best practices, resources needed, cultural awareness, and training needs to support the rehabilitation and recovery of this client group.
One 45-minute, recorded interview via Zoom
$50.00 Amazon gift card
Substance abuse treatment provider
Opiate pain medication prescriber
Service provider in PA
Provide services to immigrants (non-citizens)
No experience with immigrant patients/clients
No experience with opioid use disorder
Impact of fermented pulses on inflammation and the gut microbiota
The purpose of this study is to investigate whether fermenting pulse foods (e.g. beans, chickpeas, lentils, peas, etc.) changes their effects on the gut microbiome and inflammation. Participants will eat provided meals of either fermented or unfermented pulses, providing blood and fecal samples at the beginning of the study and after two weeks of eating meals containing each of the pulse types.
The study lasts 8 weeks. 2 weeks where you do not consume any of the test food (pulses such as chickpeas, lentils, peas or beans), 2 weeks of consuming the first type of the provided meals, 2 weeks without consuming any of the test foods, 2 weeks consuming the second type of provided meals. There will be five in person visits, one at the beginning to provide consent and then one at the end of each 2 week section. At three of these visits a fecal sample will be collected, blood will be drawn and a dietary survey completed.
300
18-65
BMI >24.9
Taking any medication for diabetes or weight management
Pregnant
Allergies to meal components
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)
This is a phase 2b clinical trial looking to see if the drug PLN-74809 (bexotegrast) is effective and safe in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
If you choose to participate in this study and meet all the study entry requirements, you will be randomly assigned (by chance; like the flip of a coin) to receive either bexotegrast or placebo for the whole study. Neither your study doctor nor you will know whether you are receiving bexotegrast or placebo. You will be required to visit the Hershey Medical Center on at least 8 separate occasions over an approximate 58-week period. Procedures that will be performed during your visits include, but are not limited to, physical exams, blood tests, ECGs, completing questionnaires, lung functions tests, and CT scans.
1200
IPF diagnosis ≤ 7 years prior to screening
If on Ofev or Esbriet, must be on stable dose for >/= 12 weeks
FVC >/=45% predicted
DLCO >/= 30% predicted and </= 90% predicted
Obstructive lung disease
Current smokers
Active infection
IPF exacerbation within the last 6 months
Identifying an Alternative to the Classic Presentation of Autism: The ISM Autism Presentation
This study aims to build upon a previous study that established a different presentation of autism called the ISM presentation by using a large sample size to either confirm or dispute this presentation as an alternative to classical autism.
Participants will be required to complete a survey expected to take no longer than an hour.
At least 18 years old
Either diagnosed with autism, suspected of having autism or typically developing
The effect of muscle shortening on the force-length characteristics of neighboring inactive muscles
We are trying to better understand the ways in which people contract their muscles. Specifically, we want to learn more about how connections between our muscles influence how they produce forces. Participants in this study will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.This research will help us to understand the underlying mechanical function of muscles in a more realistic context. This understanding may also have profound implications for current computer models of muscles, which most often ignore the connectivity between muscles.
There will be one in-person visit. At this visit, participants will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.
$50
heart condition
chest pain during exercise
balance or dizziness problems
prescribed drugs for blood pressure or heart condition
PSCI 21-191: CG-745-2-08
The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.
Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Cognitive Debriefing: Developing and instrument to measure Internalized Weight Bias among Adolescents
For many years, overweight and obesity has been highly stigmatized in society, and children are often bullied or teased for their weight. Over time, these experiences can cause adolescents to feel badly about themselves and view themselves as society views them. We call this process the internalization of weight bias or IWB. IWB can increase feelings of depression and anxiety and is associated with unhealthy eating behaviors. For this project, we wanted to create a questionnaire to measure this important topic, and get feedback from adolescents and professionals to make sure the questions are correct and easy to understand. We want to recruit 20 adolescents age 12-17 and medical professionals to review some questions and provide their feedback on these questions by participating in an interview. Participants will be compensated for their time.
We would like to interview teens and health professionals to review some survey questions and make sure that the questions we use to measure this concept are appropriate. These interviews will take 60-90 minutes over ZOOM.
30.00
Access to internet
Access to video conference
Permission from Parents
No internet or video conference
Adults
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
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation
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
Home telemonitoring of bulbar function by acoustic measurement of swallowing and speech sounds in ALS
Most individuals with ALS experience changes in speech and swallowing over the course of the disease. In some, these are their initial indication of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery. This is a longitudinal home study of ALS patients to assess speech and swallowing function through use of smartphone application. The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS. Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on their cellphone. Healthy controls will be enrolled to judge the intelligibility of speech samples provided by patients in the study.
Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on a cellphone.
340
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Have symptom onset within the last 6 years
Demonstrate changes in speech or swallowing as a result of ALS.
Possess a smartphone capable of running the study application or have home wireless internet service capable of transmitting study data from a study-issued smartphone.
Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
Collaborative Research: Enhancing Speech Science Training through Collaboration: Investigating Perception of a Variable Speech Signal
In this study, we will evaluate the factors that affect how well human listeners can perceive connected speech despite variability in the speech signal. Participants in the study will be asked to judge speech segments presented to you over headphphones. For instance, we may ask you to indicate whether the sound you hear a "pa" or "ba".
Knowledge of English (Native and non-native)
Normal or Corrected to normal Vision
Lack of Knowledge of English
Vision that is not normal and has not been corrected to normal.
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 Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion
In this study, we are trying to determine whether Vitamin B6 will help improve the exercise-induced cardiovascular response in healthy participants following a procedure by restricting and recovering the blood flow to the leg.
There will be 6 in-person visits over a month long supplementation of Vitamin B6. Three visits will include a blood draw. Half of the visits will include walking a treadmill and 3 will involve foot exercise (plantar flexion)
You will receive $25/hour for in-person visits and $50 for completing the B6 supplementation
All races and ethnicities welcome
Can speak and understand spoken English
Healthy status as defined by history and physical
Females may be on oral contraceptives, but will be excluded if they are pregnant or lactating
Current smoker
Known allergy or hypersensitivity to Vitamin B6
Use of recreational drugs in the past 6 months
Taking any medication containing B6 (including multivitamins)
A Phase 2, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)
The purpose of this clinical research study is to look at how safe the study drug, ONO-2808, is and whether it works when given to people with Multiple System Atrophy (MSA). The study will look at 3 different doses of the study drug, ONO-2808, compared to a placebo.
Screening Period (up to 6 weeks):The purpose of the Screening Period is to make sure the study is right for you. The Screening Period may be done over 2 days. This is to give you plenty of time to eat, rest and navigate through the study center/hospital at your own pace. Double-blind Treatment Period (24 weeks)The treatment period will consist of approximately 14 visits. Visit 1 (Baseline Visit), Visit 10 and Visit 13 will be done at the study center/hospital. Each visit may be done over 2 days. For the remaining visits, a nurse from IQVIA’s Research Nurse and Phlebotomy Solutions (RNPS) will come to your home to perform visit procedures. It is expected that these visits will take about 2 hours. All necessary safety measures will be taken during these visits. Your study medication may also need to be delivered to your home address. In this case, you or your caregiver will need to receive and sign for the study medication.You may be asked to come to the study center/hospital for extra visits (unscheduled), if the study doctor feels it is in your best interest.You may be allowed to continue taking medications to treat your MSA symptoms. Your study doctor will discuss this with you.After you complete the 24-week treatment period, you may be eligible to receive ONO-2808 in a separate study.Follow-up Period (4 weeks after last dose of study medication):You will have a follow-up visit about 4 weeks after your last dose of study medication. This visit will be done at your home in a similar way to your home visits during the Double-blind Treatment Period. It is expected that this visit will take about 2 hours.If you are eligible and volunteer to receive ONO-2808 after the 24-week treatment period, the follow-up visit will not be required.Early Termination Visit:If you stop the study early, you will be asked to come to the study center/hospital for an Early Termination Visit. This visit may be done over 2 days.Study visits include questionnaires; physical/neurological exams; vital signs and blood pressure measurements; ECGs; blood draws, including HIV and hepatitis testing; urine tests; and brain and liver MRIs. Pregnancy testing is required for female participants.
750.00
Diagnosis of clinically-established or clinically-probable MSA-parkinsonian type or MSA-cerebellar type
Participants at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA: parkinsonism, ataxia, orthostatic hypotension and/or urinary dysfunction
Ability to take at least 10 steps, turn around, and walk at least another 10 steps without the assistance of another person. Assistive devices are allowed.
Ability to swallow oral medication
Regular use of neuroleptics within 6 months prior to the initial evaluation by the study team
Patients with documented liver diseases or cirrhosis
Inability to undergo MRIs
Understanding Shooter Dynamics with VR
We are trying to characterize the movement of a shooter in a VR environment.
The study consists of one visit lasting approximately 30-40 minutes: 10 minutes for VR setup, 15 minutes for simulated test, and 5-15 minutes for post-experiment survey. During the simulated test, participants will be asked to move around in the environment and shoot NPCs.
$20
Male.
Not prone to nausea when experiencing VR.
Do not identify as male.
Prone to nausea when experiencing VR.
Non-Hispanic Black Individuals and Vascular Function
This study will examine the impact of age, sex, and racial/ethnic background on vascular function.
There will be three (3) in-person visits: one screening, one experimental visit, and one visit to return equipment. Equipment includes a 24-hour Ambulatory Blood Pressure monitor and an 8-day accelerometer (physical activity tracker). Blood will be drawn at the screening and experimental visit. Participants will undergo tests for cardiovascular measures during the experimental visit.
$100
Male or Female
Identify as Non-Hispanic Black or Non-Hispanic White
Tobacco consumption (e.g., smoking) or Recreational drug use (e.g., marijuana)
Pregnant and/or breastfeeding
Taking blood pressure medication
Diagnosed with metabolic and/or cardiovascular disease(s)
Oxidative Stress and Harmful Constituent Levels Associated with Little Cigars
The propose of this voluntary research study is to look at the effect of little cigars on biomarkers of potential harm with a focus on oxidative stress and inflammation. The study is also interested the effect of flavors in little cigar.
Subjects will attend 7 study visits over 7 weeks. They will be sent home with a selection of little cigars to use during the first week. Starting at week 2, they will be asked to smoke a certain cigar each week for the next 6 weeks at their study visit. They will be asked to answer a series of questionnaires and to provide biosamples (Exhaled Carbon Monoxide, Exhaled Breath Condensate, Buccal Cells, Urine and Spirometry).
600
Daily tobacco smoker
No serious quit attempts in previous 30 days
Respiratory diseases
Substance Abuse
Understanding Suicide and Self-Harm Among Young Adults in Daily Life
This study explores participants mood and how it changes from day to day and how mood and other things like personality and relationships influence thoughts of suicide or self-harm. Participants will both track and be able to visualize their mood and other experiences on a daily basis from their own smartphones.
There will be a set of questionnaires to complete online that will last between 45 and 90 minutes. Then participants will complete very brief (about 2 minute) surveys a few times per day on their smartphone over 12 weeks.
$140
Undergraduate student at Penn State
Have thoughts of suicide or self-harm in the past 12 months
Own and use an Apple iOS or Android smartphone device
Not a Penn State undergraduate student
Does not own an Apple iOS or Android smartphone device
Unwilling/unable to download and utilize study smartphone app