The objective of this study is to evaluate the performance of the Truvian System with clinical specimens. Blood samples from enrolled patients will be tested in one or more of three study arms to generate data demonstrating the clinical performance of the Truvian System:Study Arm 1: Method Comparison Assesses the degree of agreement between Truvian System s results and an FDA-cleared comparator method for each analyte.Study Arm 2: Whole Blood Precision Assesses the precision performance of the Truvian System, incorporating sources of variation including sites, operators, samples (normal and abnormal), and instruments.Study Arm 3: WBC Flagging Assesses the degree of agreement between Truvian System s WBC Flagging compared to the reference method (manual WBC differential).THIS STUDY IS ENROLLING BY INVITATION ONLY -   Participants will be recruited and enrolled four or more point-of-care clinical sites. Subjects will be 18 years or older and include apparently healthy individuals with normal test results for the TruWellness Panel™ analytes as well as individuals with comorbidities/disease states associated with abnormal test results for one or more of theTruWellness Panel™ analytes. Study sites will include primary, urgent care, and emergency care clinics at community and academic medical centers. Clinical Sites will recruit individuals to collect samples to fill the reference range for each laboratory test that is on the Truvian System. Once enough samples have been collected for a specific condition and that reference range is filled, enrollment for that population will cease.

This prospective, observational study characterizes prevalence of food insecurity and other social determinants of health in families of neonates admitted to the level 3 and level 4 NICU. We aim to assess correlation of food insecurity with breastmilk provision at discharge. Other aims include correlation of food insecurity with maternal complications and neonatal complications.THIS STUDY IS ENROLLING BY INVITATION ONLY - Study team will review admissions to Riley NICUs and EHR will be scanned for the minimum needed data by to identify admitted neonates with mothers who meet study eligibility requirements. The mother will be approached by medical or research team to see if they would be interested in participating. 

This phase II/III trial tests the safety, side effects, and best dose of the drugbozantinib in combination with standard chemotherapy, and to compare the effect of addingbozantinib to standard chemotherapy alone in treating patients with newly diagnosed. Cabozantinib is in a class of medications called kinase inhibitors which blockgnals affecting new blood vessel formation and the ability to activate growthgnaling pathways. This may help slow the growth of tumor cells. The drugs used in standardhemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexateking DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing org the growth of tumor cells in the body. Cisplatin is in a class of medications knownum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma. THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.  Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632

The cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator elexacaftor/tezacaftor/ivacaftor (ETI) has been life changing for many persons with CF (PwCF) by reducing CF exacerbations. Although ETI has shown benefit for many PwCF, adverse events (AEs) have been reported. The objective of this proposal is to, generate key preliminary data that can be used to design a prospective multicenter clinical trial that aims to define mechanisms driving AEs following CFTR restoration. The rationale for the proposed research is that ETI blood concentrations have high patient variability, yet we do not understand if drug concentrations correlate with AEs. To answer questions that are necessary to inform a large clinical trial, we will conduct the following specific aims: Examine the feasibility of evaluating ETI associated AEs based on a pharmacokinetic (PK) study of PwCF and; Determine if ETI-associated AEs are concentration dependent. We anticipate at the completion of this study will determine if ETI blood concentrations correlate with AEs and determine the value of proceeding with a large-scale trial.THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be identified by either the CF clinical teams or trained clinical research team members. Once prescreening confirmation has been received from the potential participant’s primary clinical team, a research team member will approach eligible participants to discuss the study at a clinic appointment or by telephone.

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.THIS STUDY IS ENROLLING BY INVITATION ONLY

The objective of this study is to pilot test a multi-level intervention designed to address patient- and system-level social and structural determinants of health (SSDOH) variables and facilitate access to curative hepatocellular carcinoma (HCC) therapies, including liver transplantation and resection, in a cohort of Black patients with Barcelona Clinic Liver Cancer prognosis stage 0, A and downstaged B disease. The main aim of this study is to estimate the effect of the HCC-EduLink intervention on the time to receipt of curative therapies and HCC related knowledge in Black patients with HCC.THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.  Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632