This multi-center study will compare multi-target DNA and quantitative FIT stool-based testing to colonoscopy in individuals with Cystic Fibrosis (CF) undergoing colon cancer screening with colonoscopy. The primary endpoint is detection of any adenomas, including advanced adenomas and CRC.

Prospective study to compare safety of upper versus lower extremity injection agitated saline (bubble study) using echocardiography of the heart.

Patients greater than or equal to 3 years of age and < 22 years of age with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma using reduced craniospinal radiotherapy.

The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.

The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome

This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).

TRACK-FA is a multi-site, international, prospective, observational neuroimaging study in Friedreich’s Ataxia. The objective is to obtain natural history MRI and MRS data over time in the brain and spinal cord in a large cohort of FRDA patients and healthy control. This will permit validation of neuroimaging biomarkers in FRDA for future clinical trials. In addition to neuroimaging data, the study will collect data from clinical, cognitive and mood assessments as well as blood samples to measure blood markers (frataxin and neurofilament light chain). The present IRB protocol covers only subjects enrolled at the University of Minnesota.

The study objectives are to compare the effect of 2 different physical activity programs on physical activity levels in adolescents and young adults who received and completed treatment for cancer and to measure lab tests associated with heart health and information collected from surveys to learn how changes in physical activity levels affect health and quality of life in participants.

The study consists of a Phase 1 dose-escalation portion (including both single and multi-dosing cohorts), a Cold Antibody Sub-Study, and a Phase 2. This is a Phase 1/2 clinical trial of a therapeutic investigational drug called [225Ac]-FPI-1434 to investigate safety, tolerability, pharmacokinetics, and anti-tumor activity. The study uses two additional investigational products: • [111In]-FPI-1547 Injection (imaging agent) • FPI-1175 Infusion (cold antibody)

This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 60 ml/min/1.73m2, or the patient is post renal transplantation.

Feasibility Study to Evaluate the Safety and Efficacy of Cellular Matrix BCT-HA Kit as a New Treatment Option for Dehydrated and Wrinkled Skin

Neuspera’s Implantable SNS System is indicated to treat subjects with UUI who have failed or could not tolerate more conservative treatments. A group of up to 170 subjects will be implanted with the Neuspera implantable neurostimulator and each subject will undergo a trial of the system for up to 21 days. The same number of hours of daily stimulation will be selected for use by all subjects depending on the results of Phase I and other considerations at the discretion of the sponsor. The objective of Phase II is to assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

The primary objective is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per investigator assessment.

The two primary aims of the study are: -To evaluate the efficacy of PEER and BWL on the target adolescent’s weight over the 18 months of the study, and -To evaluate the efficacy of PEER and BWL on the target adolescent’s emotion regulation skills and emotional eating over the 18-months of the study.

To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature

The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.

This is a multicenter, open-label extension study for eligible subjects who completed Study RIN-PH-304. The primary objective is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with PH-COPD.

This phase II trial studies OST31-164 as a single agent every 3 weeks for 48 weeks, with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until Week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria. Following treatment discontinuation, all patients will enter a 3-year survival follow-up period. The primary endpoints are disease control during the first 12 months after enrollment and safety assessments (adverse events [AEs], physical examinations, clinical laboratory tests, vital sign measurements, performance status, and tests to monitor for the persistence of Lm).

The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.

Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis

This is an open-label single arm trial of letermovir (LTV, Prevymis) for prevention of recurrent CMV infection in allogeneic hematopoietic cell transplantation (HCT) recipients with history of CMV infection. The study is being conducted at MSKCC and at the University of Minnesota. Thirty-six HCT recipients who are ≥12 years of age, had clinically significant CMV infection treated with CMV antivirals and are at high risk for recurrent CMV infection, defined as receiving a transplant from an HLA mismatched donor (including cord blood), acute or chronic graft versus host disease (GVHD) requiring either topical and/or systemic steroid treatment within 14 days prior to enrollment, or T cell-depleted (CD34+-selected) allograft, will be eligible to participate in the study.

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.

The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.

This phase I/II trial tests the safety, best dose, and whether BAY 1895344 (elimusertib) monotherapy works in treating patients (≥ 12 months and ≤ 30 years) with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

This is a multicenter, cross-sectional study to summarize the Lp(a) distribution in subjects with documented history of MI and/or PCI as defined by their medical history. Subjects will be eligible for the study if their Lp(a) value is unknown or is known to be greater or equal to 90 mg/dL (if measured in mass), or greater than or equal to 200 nmol/L (if measured in molar). For the subset of subjects with known Lp(a), historical values will be used. In cases where Lp(a)data are not available, blood sampling will be performed to analyze Lp(a) through local laboratories. Medical history and laboratory values for Lp(a) will be collected retrospectively, where available. One study visit is required for data collection and a blood draw to determine Lp(a), if required.

This is a multicenter, cross-sectional study to summarize the Lp(a) distribution in subjects with documented history of MI and/or PCI as defined by their medical history. Subjects will be eligible for the study if their Lp(a) value is unknown or is known to be greater or equal to 90 mg/dL (if measured in mass), or greater than or equal to 200 nmol/L (if measured in molar). For the subset of subjects with known Lp(a), historical values will be used. In cases where Lp(a)data are not available, blood sampling will be performed to analyze Lp(a) through local laboratories. Medical history and laboratory values for Lp(a) will be collected retrospectively, where available. One study visit is required for data collection and a blood draw to determine Lp(a), if required.

This is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in patients on an IPD maintenance flush schedule.