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1. Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on Recovery (DISCOVERY)

   Rochester, Minn.

   The purpose o fthis study

   A total of 8,000 patients presenting to CPSs with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled within 6 weeks of stroke onset.

   All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.

   Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit: Tier 2 participants will also undergo MRI scanning, comprehensive cognitive assessment batteries and longitudinal blood collection; and Tier 3 participants will also complete amyloid- and tau-PET/CT scans.

2. A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

3. A Registry for Children Treated with Proton Radiation Therapy

   Rochester, Minn.

   The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.

4. Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

   Rochester, Minn.

   The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.

5. Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

   Rochester, Minn., Mankato, Minn., La Crosse, Wis., Jacksonville, Fla., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.

    

6. A Study of Demyelinating Lesions as a Cause of Progressive Motor Deterioration

   Rochester, Minn.

   The purpose of this study is a comprehensive review of the clinical and radiologic history in these patients as well as review of neuropathology in deceased patients, where available.  The goal of this research is to investigate the hypothesis that this presentation represents a spatially limited form of CNS inflammatory demyelinating disease.

7. A Study to Evaluate the Spectrum of Healthy Pediatric Inflammatory Responses to Vaccinations

   Rochester, Minn.

   The purpose of this study is to understand the role of systemic inflammation in the genesis of seizures in susceptible children by gaining a clearer understanding of the spectrum of inflammatory responses that occur in healthy children post-vaccinations.

8. Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE

   Rochester, Minn.

   The purpose of this study is to evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks. Also, to investigate the effect of NBI-921352 on long-term seizure control.

9. A Study to Clarify the Relationship Between Autonomic Nervous System Regulation and Cognitive Performance

   Rochester, Minn.

   The purpose of this study is to measure changes in autonomic nervous system functioning to show the impact of down-regulation techniques under cognitive stress.

10. Cerebral Spinal Fluid Evaluation in Individuals Who Have Idiopathic Normal Pressure Hydrocephalus (INPH)

    Rochester, Minn.

    The purpose of this study is to further characterize the serum and Cerebral Spinal Fluid (CSF) biomarker profile of idiopathic normal pressure hydrocephalus, both before and after VP shunt placement, and help differentiate this profile from Alzheimer’s disease.