Clinical trials

The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The primary aim of the study is to quantify volume change of the lower face rea over time after injection of filler. The secondary aim is to collect patient related outcomes (PROs) via FACE-Q. Participants will receive hyaluronic acid filler injections (Restylane Lyft(for contouring of the chin. Each patient will receive FDA approved dosages of filler to the lower face region to treat chin regression or chin contouring, as per FDA approved indications. Prior to injections patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 moths for re-imaging.

This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.

This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.

Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

Patients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH. Subjects will be asked to attend a baseline visit where the following will be performed: * Measure your vital signs * Undergo a research blood draw, less than 4 tablespoons * Provide a urine pregnancy test (if applicable) * Review demographics, personal history, and medical history * Review current PAH medications * Complete questionnaires on how your PAH affects you * Complete a test of physical performance * Complete a grip strength test * Undergo an echocardiogram (Echo) * Complete a six-minute walk test * Undergo a Chest CT Scan * Undergo a scan of your body composition (DXA scan) * Obtain a weight and body composition measurement on the InBody Scale Subjects will also complete activity moniotring, two 24-hour diet recalls, and participate in remote follow-up visits every 6 months

Elexacaftor/Tezacaftor/Ivacaftor or Trikafta improves lung health in people with cystic fibrosis (CF), including decreased cough and mucous production. Diagnosing lung infections has become more challenging due to the decrease in sputum and rise of telehealth services. While the option of collecting sputum samples at home and sending them by mail may be feasible, uncertainty remains about how the collection of samples outside of clinic and delays in testing while in the mail impact infection detection. This study will compare bacterial cultures using sputum samples collected at home versus samples collected in clinic (saline-induced sputum and throat swab). This study seeks to shed light on how valuable home collected samples can be and help us better understand the usefulness of home-collected sputum samples for both clinical and research purposes.

This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy. Microvascular flow will be assessed by quantitative angiography before and after the intra-arterial drug administration in order to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging, final infarct volume will be quantified 72 hours following treatment, and functional outcome will be assessed in the short-term by the NIHSS and in the long-term by the 90-day modified Rankin Scale.

This study is a prospective, randomized, crossover clinical investigation designed to evaluate the accuracy, efficiency, and usability of the Vision Trainer software for subjective refraction. The study compares software-guided refraction, implemented using both Jackson Cross Cylinder (JCC) and Non-JCC workflows, against standard unassisted manual refraction performed by trained examiners

The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools. STEP-UP is an innovative model for PrEP delivery that positions community-based organizations (CBOs) as hubs for PrEP access. STEP-UP builds on the established trust, community expertise, and comprehensive services of CBOs serving individuals who could benefit from HIV prevention tools, integrating telehealth PrEP delivery into their existing infrastructure through partnership with a local telehealth PrEP program. By enabling CBOs to offer telePrEP navigation within their array of health and social services, STEP-UP creates accessible, comprehensive care centers that address barriers to PrEP access faced by individuals who could benefit from HIV prevention tools. The main questions it aims to answer are: 1. Is STEP-UP acceptable and feasible to implement in community settings? 2. Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model? Researchers will compare people who receive telehealth PrEP services through STEP-UP at community-based organizations to those who access telehealth PrEP through the existing direct-to-consumer telehealth model. Some participants will: 1. Complete surveys about their experiences with the program 2. Participate in an interview to share their perspectives and feedback about the program.

Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.

This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes. The objectives are: 1. To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness. 2. To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care. Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.

Electronic consultations, or e-consults, let a primary care doctor request medical advice from a specialist without requiring the patient to attend a separate visit. Artificial intelligence (AI) systems may be able to provide this type of advice, potentially making e-consults faster and less costly. However, whether AI-based e-consults are acceptable may depend on how patients and clinicians weigh factors such as who provides the advice, how quickly it is received, its cost, and its quality. The purpose of this study is to examine how older adult patients and primary care clinicians weigh these factors when comparing e-consults produced by a human specialist with those produced by an AI system. In the study, participants will complete a one-time survey in which they compare sets of two hypothetical e-consults. Each e-consult will include a different combination of features, such as whether the advice comes from a human or AI, the expected wait time, the cost, and the quality of the advice. This study will estimate how much patients and clinicians value each feature in an e-consult. The findings will inform the potential future AI e-consults, so they better reflect patient and clinician preferences.

To assess the potential effects of our multi-level implementation strategies for increasing SBIRT for alcohol use among cancer patients and to refine our methods, the investigators are conducting a pilot-trial with 4 clinics and will be doing interviews with patients and clinicians. The investigators will use a pragmatic, randomized clinical trial design, with 2 clinics randomized to our multi-level implementation strategies and 2 clinics randomized to usual care (prescreening assessment of alcohol use and patient information about alcohol use). Clinicians will include physicians as well as nurses and nurse practitioners who complete patient visits. Patients will include those diagnosed with cancer who have completed the alcohol use prescreening at a visit within the previous 30 days; the investigators will not deliver implementation strategies until at least 7 days following the initial prescreening given the informatics need to deliver messages to eligible patients at the point of care. Patients in the usual care arm will receive the prescreening and information about alcohol use and cancer outcomes and who to contact for further assessment integrated into their "After Visit Summary"; clinicians in the usual care sites will receive information about alcohol as a determinant of cancer outcomes and who to contact for referrals for screening at the outset of the pilot trial. Each patient who completes the subsequent clinic visit where the patient and clinician directed nudges are delivered (in the multi-level intervention arm) or not (usual care) will be tracked for 6 months to determine if SBIRT for alcohol use was completed (the primary outcome variable). Lastly, 10 patients and 10 clinicians will be invited to complete key informant interviews to provide feedback about their experiences with the implementation strategies.

This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.

The right dorsolateral prefrontal cortex (dlPFC) is increasingly being targeted with transcranial magnetic stimulation (TMS) to reduce anxiety expression; however, there is little mechanistic evidence supporting an optimized treatment protocol. Thus, the objective of the current project is to develop an interleaved TMS/fMRI that can assess the effect of neuromodulatory (potentially therapeutic) TMS protocols on neural and behavioral measures related to anxiety expression. PUBLIC HEALTH RELEVANCE: These results will yield direct evidence that 1 Hz and cTBS modulate brain activity associated with anxiety expression and regulation, thus informing novel TMS based anxiety treatments.

This proposal will determine if a Disparities in Labor Outcomes dashboard can be used as an implementation strategy to increase compliance to an evidence-based set of interventions for labor induction in a two-site difference-in-differences study design.

DE-RESTRICT is a pilot study testing whether a strategy to reduce the use of activity restriction and bedrest in pregnancy is acceptable, appropriate, and feasible for prenatal care providers, and whether it changes how often activity restriction is recommended. Activity restriction and bedrest are commonly advised to try to prevent preterm birth, but they do not prevent it and may cause harm, and national guidelines recommend against them. The study takes place at two prenatal care settings within one health system and unfolds across four periods. In the pre-deimplementation period the study team develops a local clinical guideline and measures baseline outcomes. In the run-in period most provider education is delivered through interactive sessions with feedback, and audit and feedback begins. In the maintenance period audit and feedback continues. In the post-deimplementation period audit and feedback continues and outcomes are measured again. The study measures provider acceptability, appropriateness, and feasibility, the rate of activity restriction recommendations, patient-reported wellbeing and care experience, and the preterm birth rate.

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

This study aims to investigate the impairing effects of known central nervous system (CNS) stressors in a controlled environment in order to predict and mitigate analogous risks in spaceflight. Up to 56 healthy individuals aged 25-60 will spend approx. 110 hours in a laboratory, where they will be exposed to 27 hours of sleep deprivation and will consume alcohol to reach a BAC of 0.08 on a separate day. They will perform cognitive and sensorimotor tasks and undergo MRIs and blood draws.

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Aim 1: Measure local shifts in cortical spectral dynamics following aiTBS. Aim 2: Measure network-specific shifts in task performance following aiTBS. Exploratory aim: Evaluate changes to resting state spectral dynamics in absence of stimulation after aiTBS.

Aim 1: Active cTBS to IPS will disrupt arousal-dependent temporal memory, reflected in reduced relative order discrimination accuracy and expanded temporal distance estimates, relative to sham. Aim 2: Active iTBS to IPS will enhance arousal-dependent temporal memory, reflected in improved relative order discrimination accuracy and compressed temporal distance estimates, relative to sham. Aim 3: Baseline physiological arousal, trait anxiety (STAI), Beck Anxiety Inventory (BAI), trauma symptoms (PCL-5), and individualized E-field strength will predict the magnitude of TBS-induced behavioral changes in temporal memory.

This is a multicenter non-randomized prospective open label trial of partial enteral nutrition (PEN) among patients with active Crohn's disease (CD) starting standard of care advanced therapy. Our central hypothesis is that combination therapy of PEN and pharmacologic therapy is more efficacious than pharmacologic therapy alone and can be well-tolerated for patients. Participants will choose to either include PEN along with starting their advanced therapy or will choose not to include PEN. 80 participants will be recruited from 15 sites across the United States.

The project will be performed over a period of approximately two years. In the first year the \[18F\]FTHA tracer will be developed, optimized, and tested on normal volunteers. During the second year, the tracer will be investigated on patients with suspected obstruction of the thoracic duct (TD).

The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +/- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.