Search Results
Augmented Reality: Perceptions, Performance, and Language Enhancement
This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication.Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.
Participants and their caregivers will complete a single visit at the Hershey Medical Center lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.
$25
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
ALL ALS-ASSESS
This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.
Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites.During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months.Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.
Up to $350
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
ALL ALS-PREVENT
The primary purpose of this study is to collect samples and health information from individuals who are genetically at risk for ALS to better understand ALS and how the disease progresses.
Study visits will be conducted both in an in-clinic setting and remotely with 14 visits over the course of 36 months (3 years). Participants will complete a total of 10 visits over the course of 36 months (3 years). There will be a screening visit onsite in the clinic; 3 in-person onsite clinic visits once a year; and 6 remote visits once every 4 months. Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study.Biospecimens will be collected alongside COA to support biofluid biomarker analyses. Biospecimens will include plasma, serum, RNA, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF) via lumbar puncture (LP). To supplement annual in-person visits, participants will undergo additional biofluid collection (plasma, serum and whole blood) which will be remotely collected through home phlebotomy.
Up to $780
Capable of providing informed consent and willing to follow study procedures.
First-degree relative of known carrier of ALS gene OR First-degree relative of individual with ALS and/or FTD in a family with a “compelling family history” of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members.
Access to a smartphone, computer, or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Genetic Testing Sub-Study: Currently enrolled in the PREVENT ALS Study
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant, unstable medical condition that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.
Optional Lumbar Puncture: Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Genetic Testing Sub-Study: Presence of unstable psychiatric illness (psychosis, active suicidal ideation, suicide attempt, or untreated major depression) in whom predictive genetic testing would confer a high risk of harm.
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma
We are asking you to take part in this voluntary research study because you have a brain tumor (glioblastoma) that has gotten worse despite first treatment.The purpose of this voluntary research study is to is to learn if the SonoCloud-9 (SC9) implantable device can be used in combination with Carboplatin chemotherapy to help control glioblastoma at recurrence. Neither Sonocloud-9 (SC9) in combination with Carboplatin chemotherapy is not FDA approved.
As part of your routine care, you will be asked to undergo surgery to remove the tumor that has come back. You will be randomized into one of the treatment groups. If you are in the study drug group the surgeon will insert the SonoCloud-9 device (SC9) implant into the skull bone at the end of the tumor resection surgery. If you are in the routine treatment group, the surgeon will close the wound without implanting the SC9 device.The treatment itself will start within 12 to 21 days after the randomization.-If you are in the study drug group you will receive up to 7 doses (every 3 weeks) of Carboplatin at the same time the SonoCloud-9 device is being activated. Further details on the procedures are described below. A brain MRI (Magnetic Resonance Imaging) scan will be performed after the first cycle as part of the research to evaluate opening of the BBB (blood-brain barrier). -If you are in the routine treatment group, you will receive up to 4 doses of Lomustine (every 6 weeks), or, if considered as best appropriate, up to 6 doses of Temozolomide (every 4 weeks). Additional in-person hospital visits or telehealth consultations by video or phone will be performed at regular intervals.
Received prior first line therapy
First disease progression
Proven glioblastoma
At least 18 years old
Medical need to be on continued anti-platelet aggregation therapy or coagulation
Peripheral neuropathy
Uncontrolled epilepsy
Known sensitivity/allergy to gadolinium
Stepping and Balance in Young and Older Healthy Adults Walking on Winding Paths
As we walk, we have to stay balanced to avoid falling while also being able to maneuver along various paths that are most often not straight. This study will test younger and older healthy adults walking on paths of varying complexity and difficulty to determine how they negotiate achieving these various task goals. We predict that older adults will have greater difficulty successfully completing these tasks and will use different motor control strategies to do so.
There will be one in-person visit (easy free parking is available). This visit should last no more than 2 hours total.We will ask you to complete a health history questionnaire, do some basic visual assessments, and physical assessments. Your height, weight, and blood pressure will also be taken. After screening, you will walk on a treadmill in a virtual reality environment. We will ask you to walk on various different paths. Your task will be to stay on a path that may be windy and/or difficult to see. Treadmill walking will take less than an hour and you can take rest breaks as needed.
$30.00
No medications or health conditions that significantly impair your walking ability.
Body Mass Index (BMI) more than 18 and less than 30
Normal corrected vision (≥ 20/40)
Able to walk un-assisted for at least 5 minutes without shortness of breath, chest pain, or joint pain in the legs, neck, or back
Feasibility Study of a Training/Certification Program to Improve Health Care Outcomes for Individuals with Autism
This feasibility study will examine interest and attitudes in a possible training/certification program relating to health care outcomes for individuals with autism. The study will utilize a survey distributed to staff in health care settings. The survey will explore staff preferences regarding training formats and training incentives as well as current accommodations offered to patients with autism. The data from the survey answers will guide researchers to the most effective type of training modules to support health care professionals in providing health care to individuals with autism. In addition, the survey answers will provide researchers with the tools needed to offer support to medical professionals and other office staff members to provide purposeful accommodations with patients with autism.
Participants will be asked to complete an online survey.
English as primary language
Work in a licensed health care setting
Have direct contact with patients
English is not the primary spoken language
Do not work in a licensed health care setting
Do not have direct contact with patients
A Phase 2 Long-Term Open-Label Trial to Assess the Safety andEfficacy of Repeat Dosing of STAR-0215 in Adult Patients withHereditary Angioedema (The ALPHA-SOLAR Trial)
The purpose of this study is to collect long-term safety data and to assess the efficacy of STAR-0215 in subjects with Type I or Type II Hereditary Angioedema (HAE).
Participants will answer questions about your health, provide blood samples, undergo routine urine laboratory tests, receive the study drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide Hereditary Angioedema (HAE) attack information. Participants in this study will have 17, 18, or 23 in person visits and 4 or 9 remote visits (phone contacts) depending on the Dosing Regimen.
AT least 2 HAE attacks during the Run-In Period between Screening and the Treatment Period.
Agree not to receive a dose of any vaccine within 7 days before or after study medication administration.
Diagnosis of another form of chronic angioedema besides HAE.
Active cancers except for basal cell skin cancer.
Clinical Decision Making
This study investigates how clinicians (medical students) assess pain during simulated patient interactions. Participants will watch videos depicting patients with varying pain levels, while their brain activity is monitored using functional Magnetic Resonance Imaging (fMRI). The research aims to understand the neurological and behavioral responses in clinical decision making enhancing our knowledge of clinical practices and patient care.
Participants will complete pre-visit questionnaires at home, engage in simulated clinical interactions during a single lab visit fMRI session, and fill out post-visit questionnaires immediately after the MRI. This study is designed to assess their clinical decision-making in response to pain scenarios.
250-400
2.Currently enrolled as either 4th-year medical students at Hershey Medical Campus or University Park, or pre-medical students who have been accepted into a medical program for the 2024 academic year.
3.No reported substance abuse within the past year.
4.Capable of performing experimental tasks, including speaking and reading English, following instructions, and tolerating an fMRI scan.
5.Fluent or native English speakers.
2.Inability to tolerate scanning procedures, including claustrophobia.
3.Presence of metal in the body or a history of working with metal fragments that pose a risk in MRI environments.
4.Contraindications for MRI examination, such as metallic implants, pacemakers, surgical aneurysm clips, nicotine patches, or known metal fragments in the body.
5.History of neurological or systemic disorder that could impair cognitive function.
A PHASE 2, SINGLE ARM, OPEN LABEL EXTENSION STUDY, EVALUATING THE LONG-TERM SAFETY AND CLINICAL EFFICACY OF INBRX-101 IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA
The study will test INBRX-101 as an experimental drug to treat patients with Alpha-1 antitrypsin deficiency. “Experimental” means the drug has not been approved by any authority that regulates new medications, including the US Food and Drug Administration. Therefore, it can only be used in a research study. INBRX 101 is an artificial form of Alpha-1 antitrypsin that has been altered to last longer in the body. This means that INBRX-101 could be given less frequently than the currently approved augmentation therapies for this condition because it works for longer in the body. Its purpose is to understand the safety and therapeutic effects of INBRX-101 over 3 years. All patients in this study will receive only INBRX-101.
You will visit the study site for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion. Some visits may be completed with assistance from a home healthcare organization. The study will last approxiately 3 years.
Diagnosis of Alpha-1 Antitrypsin Deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Alpha-1 Antitrypsin Deficiency genotype of Pi*ZZ, Pi*ZNull, Pi*MaltonZ, Pi*NullNull, or Pi*Mheerlen.
On waiting list for lung or liver transplant
Active cancers or has a history of cancer within 5 years prior to screening
Current substance and/or alcohol abuse
PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER
This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.
Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.
The Association Between Head Cooling and Cognition, EEG Patterns, Neuroinflammatory Cytokines, and Mental Health
This research is being done to find out the effects of head cooling on cognition, brain activity as seen in EEG scans, inflammation of the brain, and mood in healthy subjects. What is specifically meant by healthy subjects in the context of this study is subjects who are not currently recovering from a traumatic brain injury.
This study includes an 8-day regimen of head cooling or rest at an average of 30 minutes per day, non-invasive cheek swabs used to collect saliva samples, and non-invasive brain activity testing and questionnaires.
$40
Currently NOT recovering from a brain injury
Currently recovering from a brain injury
Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients(Ages 2-11) with Hereditary Angioedema Type I or II
The purpose of this research study is to test the safety of the study drug, sebetralstat and to see if it can treat Hereditary Angioedema (HAE) at the time of an HAE attack and to determine how children's bodies absorbs, breaks down, and remove sebetralstat.
You and your child will be expected to attend all study visits, complete the HAE attack diaries to the best of your ability, and tell the study staff about changes to your child’s health, medications, and other medical treatments. Your child is expected to take the study medication as instructed and will allow study staff to draw blood.
Diagnosis of Hereditary Angioedema (HAE) Type 1 or Type 2
At least 1 HAE attack in the last year
Caregiver must be able to appropriately store and administer the study medication
Caregiver must be able to complete a paper diary about attack information
Child participated in a investigational clinical trial within 4 weeks prior to the screening visit
GLP-1R Agonist Treatment for Opioid Use Disorder - A Multi-Site Randomized Placebo-Controlled Trial
This is a multi-site, double-blind, placebo-controlled trial to determine if the study drug, semaglutide, will reduce illicit opioid use and craving in opioid-dependent patients receiving treatment for opioid use disorder. The study drug, semaglutide, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, but it is not specifically approved for the treatment of cravings and opioid use in patients with substance use disorders. Therefore, its use in this research should be considered “investigational.”
A screening visit will take place to see if you eligible to receive the research treatment, which will include urine (for drugs and pregnancy) and blood tests as well as questionnaires about your mental health and drug use. If you are eligible to continue in the research, we will randomize you to either the study medication or the placebo, which you will receive once a week for 12 weeks. During the 12 weeks of treatment, we collect your vital signs, perform a physical examination (first visit only), collect your medical history (first visit only), do a urine drug screen and pregnancy test, give you questionnaires about your mental health and drug use, and ask you about the other medications you are taking. We will then administer the study medication or placebo, depending on what group you were randomized to. You will also complete surveys at set times on your smartphone. After your last treatment visit, you will return to the site two more times for study visits without any study medication or placebo administration. A blood draw will also occur at the washout visit. The smartphone surveys will continue at set times until your final study visit. You will attend a total of 15 study visits over 19 weeks.
Maximum of $873.00
Body mass index (BMI) > 18
Current diagnosis of Opioid Use Disorder
Currently receiving outpatient treatment for OUD and at least 2 weeks on BUP or 4 weeks on methadone at the study site and/or at an associated clinic
Able to read and communicate in English to the level required to accept standard care and complete all study requirements
BMI <18
Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures
Current use of medications that help lower blood sugar levels and promote weight loss
Plans for travel outside of the local area over the 19 that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study
A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema
The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the treatment of HAE. Deucrictibant is designed to block the effects of bradykinin to avoid progression of attacks and lead to the resolution of attacks. In this study, the investigational drug is a soft capsule containing 20 mg of deucrictibant that you will take by mouth. There are already medicines available to treat the manifestations of HAE attacks, but these are injected either into a vein or under the skin. If you are currently on a stable dose of prophylactic treatment to prevent HAE attacks, you will be asked to continue using this at the same dose throughout the duration of the study.
You will need to come to the study site approximately four times. At two of these visits, you will have blood and urine collected. You will have vital signs collected, physical exams, vital signs, and EKG’s performed. You will need to treat two HAE attacks with the study drug, complete questionnaires on an electronic diary, and participate in telephone interviews with the study team.
Diagnosis of HAE-1/2
History of at least 2 HAE attacks in the last 3 months before screening.
Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
Capable of recording, without assistance, electronic HAE diary using an electronic device, as evidenced by the competency assessment conducted during the screening phase.
Any diagnosis of angioedema other than HAE-1/2.
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Use of attenuated androgens for short-term prophylaxis within the last 30 days before the time of randomization.
Prior gene therapy for any indication at any time.
PSCI 23-110 CA209-6K6 An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer
We are asking you to take part in this voluntary research study because you have lung cancer that will require surgery, chemotherapy, and possibly immunotherapy. The study involves chemotherapy and immunotherapy given during the 6 weeks prior to surgery.
In person visits for Screening, Treatment and Follow-up visits. Treatment is given monthly on day 1,22 & 43. Special test will be conducted at these time periods such as Physical Exam, Blood Draws and CT/Pet scans.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
Hemoglobin ≥ 9.0 g/dL
Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids
Patients with Grade ≥2 neuropathy
History of allogeneic organ transplant.
History of hypersensitivity to nivolumab or any excipient
The Application of Mixed Methods and Social Network Analysis to Develop a Novel Measure of Social Connectedness for Adolescent/Young Adult Cancer Survivors (AYACS)
The purpose of this voluntary study is to evaluate adolescent and young adult cancer survivors’ (AYACS) social network changes over the first year after being diagnosed with cancer. This study is also exploring difference is AYACS’ social networks based on rurality. With this information, a better understanding on rural and non-rural AYACS’ social networks will be used to improve care and available resources.
As a study participant, you will complete two study visits—one after cancer diagnosis and the second one year after cancer diagnosis. Both visits should take up to about one hour and can be completed both in person and remotely. Each visit will entail the following activities: oA 30-minute interview over a secure video conference software (Microsoft Teams). The session will be audio and video recordedoSome of your contact and medical/demographic information will be collected via chart review and/or a survey. This includes but is not limited to phone number, email, race, gender, insurance, diagnosis, and other common demographic information.oNetwork Canvas social network analysis “interview” (the program’s term for a survey)oSurveys assessing social isolation and emotional support
$100.00
Within 120 days of cancer diagnosis
Participant receiving cancer treatment at Penn State Health
United States resident and English speaking
Access to computer or smartphone
Cognitive inability to participant in study
Play & Learning Across a Year
This study will record on video mothers and infants engaged in natural activities in their homes. The videos will be coded by experts in language, physical activity, emotion, and object interaction. The data will be shared with researchers via the web-based Databrary.org data library.
There will be one home visit lasting 2-3 hours. Video will be recorded of the child up to 2 years old and mother going about their day for 1 hour, play with specific toys, and survey questions for mom.
$50
primarily speak English
healthy volunteers
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF SIRNA GENE SILENCING FOR THE TREATMENT OFNON-ALCOHOLIC STEATOHEPATITIS (NASH) IN PARTICIPANTS WITH GENETIC RISK FACTORS
This is a Phase 2 drug study, using a precision medicine approach to treat a chronic liver disease called Non-Alcoholic Steatohepatitis (NASH) in individuals at increased genetic risk for this condition. The primary objective of the study is to evaluate the effect of the study drug, ALN-HSD, on the histopathologic (liver biopsy) assessment of liver fibrosis. The study has a screening period of up to 16 weeks (day -113 to -1),a double-blind placebo-controlled treatment period of 52 weeks (day 1 to 365), and an off-drug safety follow-up period of 32 weeks (day 366 to 589). In total, the study duration is approximately 100 weeks.The study drug, or placebo, would be administered subcutaneously (through a fine needle in the belly) every 4 weeks, for a total of 13 doses. During the course of the study, there will be approximately 20 visits, which will take place in the clinical research center of our hospital. At these visits, participants will receive the injections, and be evaluated for vital signs, have regular bloodwork, receive a physical, and answer questions about their well being.
There will be up to 20 in person visits. The screening visits will include bloodwork, vitals, body measurements, and some additional scans. After randomization, each visit will occur approximately every two weeks and will include blood work and a physical at each visit, in addition to the administration of the study drug.
$2000
A diagnosis of NASH with fibrosis (F) stage 2 or 3
Alcoholic liver disease
History of Type 1 diabetes
Comparison of skin menthol and other bioactive content with different commercially available topical analgesics
Menthol is the active ingredient in topical analgesics. Some manufacturers use special encapsulation techniques in order to prolong the effects of menthol. Our goal is to use intradermal microdialysis to assess how much menthol, along with other organic bioactives, are present in the skin following topical application of various commercially available topical analgesics. We also examine the affect of a menthol-based analgesic gel on the skin blood flow.
There will be a screening visit and then up to seven experiment visits where different topical analgesics will be applied to the forearm skin. We will use intradermal microdialysis and measure skin blood flow.
240
18-30 years old
Non-smokers
No use of nicotine containing compounds
No illegal/recreational drug use
Skin rash, skin disease, or disorders of pigmentation
Sensitivity to menthol
Pregnant
Breastfeeding
A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function (BalanceD-HF, D6402C00012))
The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization
Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.
up to $1,600
being treated for heart failure
undergoing treatment for decreased kidney function
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease
Alzheimer’s Network for Treatment andDiagnostics (ALZ-NET)
ALZ-NET will follow and record information about people’s health, safety, brain scans, and long-term health outcomes during their regular memory care.
At specific time points throughout your participation in ALZ-NET, your memory care provider or designated staff will transfer data about your health, diagnosis, treatment, and brain imaging that are related to your memory concerns to the ALZ-NET operations center.These time points include at a 6-month, 12-month, 18-month, and 24-month timepoint, and once per year after that until your participation ends.
Patient or patient’s legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand and provide signed and dated informed consent
Patient has a diagnosis of MCI or dementia with clinical suspicion of Alzheimer’s disease (AD)
If treatment is initiated at time of consent, the patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies
Patient’s treating clinician has made the decision to provide clinical care or treatment prior to patient consent and independently of the purpose of ALZ-NET
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women with Infertility Due to Polycystic Ovary Syndrome
This is a randomized trial whereby a study device will be used to remove tissue from the ovary via a transvaginal ultrasound procedure in order to promote/restore ovulation in women with infertility due to PCOS. Weekly serum blood draws will also be obtained to determine ovulation rates during the first 12 weeks of study enrollment. Those randomized to the control arm will have the option of crossing over to the device arm after 3 months.
Preliminary visit to assess eligibility followed by randomization into the Device or Control Arm. Device Arm requires May Health procedure (approximately 1 hour long, similar to ovarian drilling) followed by 12 weekly blood tests and 6 follow up clinic visits and follow up calls for up to 36 months after the procedur4e. Control Arm requires 12 weekly blood tests and the option to cross-over to the device arm after 3 months. If no cross-over occurs, the control arm will have one follow up visit at 3 months and can then exit the study. Both arms will complete questionnaires and log menstruation dates in an e-diary.
1220
Infertility associated with oligo or anovulation and ultrsonographic evidence of PCOS or evidence of hyperandrogenemia
At least one ovary with volume greater or equal to 10.0ml
Ovarian accessibility by transvaginal ultrasound transducer
Has not responded to first-line ovulation induction treatment
BMI greater than 40
Marked hyperandrogenism
Poor glycemic level control (greater than 6.5%)
Bleeding disorders
Interoception and eating behaviors in children
The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.
Child and parent will attend 2 visits at the Clinical Research Center, about 1-3 weeks apart.At visit 1 (~3 hours)- Your child's height and weight will be measured- Your child's percent body fat will be measured using an x-ray based technology- Your child will wear a heart rate monitor and will complete tasks where they are asked to notice or count their heartbeat- Your child will complete questionnaires via an interview with a researcher- Your child will be asked to drink several glasses of water to measure their stomach sensations- You will complete questionnairesAt visit 2 (~2.5 hours)- We will collect 4 saliva samples from your child- Your child will eat a meal and taste snacks- Your child will play brain games on an iPad- You will complete questionnaires
$100
Able to understand and answer questions in English
Any medical conditions impacting growth, eating, or heart function
Developmental delay
Autism/autism spectrum disorder
Taking medications that impact appetite
An exploratory analysis of commuting satisfaction and travel mode dissonance
The purpose of this research is to explore commuting mobility patterns and satisfaction levels among commuters in different regions and demographics. The study aims to identify barriers to current commuting practices, evaluate commuter opinions and intentions, and understand the implications of travel mode dissonance on commuter satisfaction and overall well-being. This research will also investigate how future commuting policies can incentivize sustainable commuting practices, ultimately aiming to reduce commuting emissions.
Participants will be required to complete an online survey, which will take approximately 10-15 minutes. All responses are anonymous, and participants may choose to skip any questions or exit the survey at any time without providing a reason.
Are over the age of 18
Are working or going to school (i.e., conducting a commute trip)
Use transportation systems
Children under 18 years
Individuals who do not work
PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor
this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.
Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
Locomotor Learning in Exoskeleton-Assisted Walking
The goal of this study is to explore how different ways of practicing, as well as paying attention, affect learning to walk while using an ankle exoskeleton. This pilot study will look at whether changing the settings of the exoskeleton and walking conditions frequently or not very often helps people walk better in follow-up tests. It will also examine if asking people to focus on their body (internal focus) or on their surroundings (external focus) improves their walking.
There will be three in-person visits over two days, walking in a lower limb exoskeleton will occur at all three visits.
$40.00
Normal ankle functionality
Age: 18-40 years old
Responsiveness: Subjects must be able to follow verbal instructions
Shoe size: Fit shoes sizes 6-10 (men) or 7-11 (women)
Previous or existing lower limb musculoskeletal injuries or conditions (e.g. joint replacement)
Currently using blood thinners, since this could increase the risk of bruising
Pregnant women
Subjects with femoral retroversion (duck feet posture) significant enough to cause exoskeleton collisions while walking
PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA
This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab
Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.
$202 for each visit completed
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).
The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.
Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.