Pennsylvania Paid Clinical Trials

The goal of the observational study is to learn how black and white patients with solid tumor cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological assessment through a smart phone app and surveys to assess patient-reported pain and other symptoms as to inform clinical practice and guidelines for underrepresented populations. Read Less

This Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM. Read Less

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2. Read Less

The purpose of the study is to analyze biological samples and genetic material for basic science research investigating the molecular and cellular characterization of skull base tumors. Read Less

This project will primarily evaluate the developmental/genetic basis of biliary atresia, the most common cause of liver failure at birth, and which accounts of half of all liver transplants performed worldwide in children. Read Less

The objective of this study is to evaluate whether certain proteins, expressed in biological tissues can indict a better understanding of the effect of drugs that are used to treat rejection, and of processes leading to rejection and rejection-free outcomes. Read Less

Chronic kidney disease (CKD) affects approximately 26 million Americans and disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD have significant morbidity and reduced life expectancy. In addition to excessive suffering and lost productivity, the cost of managing this epidemic has reached $40 billion annually. The recognition that CKD is a major public health problem is reflected in the fourteen objectives outlined in Healthy People 2020 to begin to address the disease burden. Advancement in approaches to halt CKD progression has been slow despite growing global awareness of disease burden. This O'Brien Kidney Research Core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. It will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. C-PROBE is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen BioBank which will store blood, urine and kidney tissue samples. A key component of C-PROBE is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina. This mechanism will feed the other Cores and provide biomedical investigators with approved projects the access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research. Read Less

Cancer is amongst the leading causes of disease-related morbidity and mortality. A major challenge in cancer treatment is the development of biology-informed, personalised treatment strategies. Recent advances in artificial intelligence (AI) and next-generation sequencing (NGS) technologies have shed further insights into disease biology and treatment pathways, thus identifying new, precision medicine-based therapeutic opportunities. The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules. Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines, chemokines and other factors. This reprogramming of the tumour microenvironment (TME) is critical for cancer progression, invasion, and metastasis. Moreover, there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME. Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment, including immunotherapy (IO) and targeted therapies. Spatially resolved-Omics is an emerging field that characterises cell types by gene/protein expressions within their spatial context in the tissue organisation. Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME. The MOSAIC study, a collaborative initiative across industry and top oncology hospitals, proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities (3 essential mandatory modalities: Clinical Data, Hematoxylin and Eosin (H\&E) microscopic image, Spatial transcriptomics; up to 3 high priority data modalities depending on technical feasibility and sample size: bulk Ribonucleic Acid Sequencing (RNAseq), bulk Whole Exome Sequencing (WES), Single-cell transcriptomics; and potentially other optional data modalities and follow-up experiments such as single-cell omics, immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules) on a minimum of 2,000 tumour samples across a different cancer indications. This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients, integrated with clinical data, at an unprecedented scale and resolution. This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection is available within their local pathology archive or their affiliate centers archives. The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery, identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms. Read Less

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months. Read Less

The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents. The specific aims are to: Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \>35% underserved youth). H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates \> 80% and imHere4U engagement \> 70%. H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period. Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \> 6. Read Less

The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery. Read Less

The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months. Read Less