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387 Study Matches

Transdiagnostic Cognitive Biomarkers

The overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. Completing behavioral paradigms with electrophysiology and TMS is a challenging frontier. This study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

David Darrow
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04864080
STUDY00011759
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Arm 1, healthy controls:
Inclusion Criteria:

• Have access to the online study platform.
Exclusion Criteria:

• under 18, non-English speaking Arm 2: pain and depression:
Inclusion Criteria:

• Pain or depression
Exclusion Criteria:

• pregnant women
Behavioral: Computer game/task, Behavioral: Health surveys online
Pain, Depression
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Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit

This study explores the relationship between ultrasound measurements of muscle and adipose tissue and clinical, metabolic, and neurodevelopment outcomes in preterm infants.

Sara Ramel
All
2 Years to 4 Years old
Pilot
This study is NOT accepting healthy volunteers
NCT03479515
STUDY00008341
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Inclusion Criteria:

• toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
• written consent obtained from a parent before or at time of visit
Exclusion Criteria:

• toddlers who require medical support that prevents them from having ADP measurements taken
• those with an inability to sit in a supported seat for 5 minutes
• those weighing less than 10 kg
Device: Ultrasound
Prematurity
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A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families

This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.

Rebekah Hudock
NA
PEDS-2021-30175
STUDY00013507
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R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis

This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis, and to compare those with healthy controls.

Maneesh Bhargava
18 Years and over
NA
This study is also accepting healthy volunteers
PACCS-2021-30089
STUDY00013734
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Inclusion Criteria:

Healthy volunteers
ages 18-80
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:
Healthy Controls:
• History/Current use of cigarette, e-cigarette, vaping or marijuana smoking
• History/Current use of nicotine products
• Presence of underlying chronic condition
• Inability to undergo procedure using IV sedation
• Weight < 110 lbs. & BMI > 35 kg/m2
• Pregnant and/or breast feeding
• History/Current use of chronic immunosuppressive medications
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Clinics and Surgery Center (CSC), Lung, Pulmonary, Sarcoidosis
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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

This study will evaluate the clinical activity/efficacy of MRTX849 in cohorts of patients having selected solid tumor malignancies with KRAS G12C mutation.

Amit Kulkarni
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03785249
STUDY00009695
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Inclusion Criteria:

• Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
• Unresectable or metastatic disease
• Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
• Adequate organ function
Exclusion Criteria:

• History of intestinal disease or major gastric surgery or inability to swallow oral medications
• Other active cancer
Drug: MRTX849, Drug: Pembrolizumab, Drug: Cetuximab, Drug: Afatinib
Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Adagrasib, STK11 mutation, KRAS G12C, Clinics and Surgery Center (CSC), Phase I Clinic
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Improving Spinal Cord Stimulation with ECAP

The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.

David Darrow
All
22 Years and over
Early Feasibility
This study is NOT accepting healthy volunteers
NCT04938245
STUDY00013100
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Inclusion Criteria:

• Medically stable as determined by the principal investigator
• Scheduled to undergo externalization of spinal cord stimulation
• English-speaking
Exclusion Criteria:

• Scheduled for permanent implantation only without trial
• Have pacemakers or other neurostimulators
• Pregnancy
Device: Spinal Cord Stimulation
Chronic Pain
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RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)

We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.

Joanne Billings
All
12 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03161808
1702M07621
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Inclusion Criteria:

• Male or female ≥ 12 years of age at time of consent
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with CF and one or more of the following criteria (1. Sweat chloride ≥ 60 milliequivalents/Liter (mEq/L) by quantitative pilocarpineiontophoresis test (QPIT) OR upon permission of the RARE Investigator- Sponsors, 2. Two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene,
• Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproterenol of lessthan -6.6 mV)
• Confirmed genotype of the current recruitment focus for certain target rare mutations. The initial recruitment focus will be CF patients who are homozygous for pre-mature stop codons. Operations Memos will detail any future current genotype targets.
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability to comply with the requirements of the study.
• Willing to travel (if needed) to a regional study site for cell collection.
Exclusion Criteria:

• Presence of a medical condition, abnormality, or laboratory value(s) that in the opinion of the onsite principal investigator and/or collaborating gastroenterologist may compromise the quality of the data or place the subject at significant risk by undergoing the research related biopsy, including: Significantly diseased distal rectal/GI tissue that could place the participant at risk by participating in the study (as judged by the collaborating gastroenterologist, such as significant hemorrhoids, vascular abnormalities, colonic infection, radiation injury or history of radiation therapy to the rectum, prostate and/or pelvic area) Any of the following abnormal lab values at the study visit: i. Platelets < 50 x 103/µL ii. Hemoglobin < 10 gm/dL iii. Hematocrit < 30% iv. WBC > 20 x 103/µL v. Neutropenia (ANC < 1.5 x 103/µL) vi. Lymphopenia (absolute lymphocyte count < 1.5 x 103/µL) vii. PT/INR > 1.5 viii. Other bleeding diathesis
• Positive pregnancy test (for female of childbearing potential) at the study visit.
• Breastfeeding (if patient opts to use sedation).
• Current use of drugs with significant risks of compromising immunity (e.g. oral steroid use >20 mg/day) for >14 days prior to the rectal biopsy.
• History of organ transplant.
• Use of oral anticoagulant medications (e.g., chronic anticoagulant therapy such as warfarin or platelet inactivators such as aspirin) within seven days prior to rectal biopsy.
• Unable or unwilling to withhold use of oral anticoagulant medications (e.g., chronic anticoagulant therapy such as warfarin or platelet inactivators such as aspirin) within 7 days after rectal biopsy.
Cystic Fibrosis
Clinics and Surgery Center (CSC)
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Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (DOORwaY90)

The purpose of this research study is to see if SIR-Spheres® Y-90 resin microspheres (“SIR-Spheres”) can treat your hepatocellular carcinoma (a common type of liver cancer). SIR-Spheres are small, radioactive beads that are injected into the liver arteries feeding the tumors with blood. The beads travel through the blood flow to the tumor, where they get stuck. The radioactivity kills cancer cells. Treatment with SIR-Spheres is investigational for liver cancer in the U.S. It can only be used for liver cancer in the U.S. by doctors in research studies like this one, with permission from an independent institutional review board (IRB). Data gathered from this study will be used to support FDA approval to sell this product in the U.S. for liver cancer.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04736121
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Inclusion Criteria:

• Willing, able, and mentally competent to provide written informed consent
• Age 18 or older at the time of consent
• All tumors must be measurable by CT or MRI according to localized mRECIST
• Life expectancy ≥ 6 months (to allow for adequate completion of study procedures and collection of data)
• Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 4 or 5 or by histology
• Treatment-naïve patients, including no prior locoregional therapies in the liver and no systemic therapy for HCC
• BCLC stage A, B1, B2, and C with maximal single tumor size of ≤8 cm and sum of the maximal tumor dimensions of ≤12 cm with the entire tumor burden expected to be treatable within the perfused volume
• At least one lesion ≥2 cm in diameter (long axis) measured according to mRECIST criteria by CT or MRI
• Child-Pugh score of A5 or A6 at baseline
• Albumin-bilirubin (ALBI) grade = 1 or 2 at baseline
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline
• Adequate blood count, liver enzymes, and renal function at baseline
• Platelet count >50,000/microliter (patients may not receive a platelet transfusion or growth factors to increase the platelet count so that the patient may be eligible for the study)
• White Blood Cell (WBC) ≥ 3 x 10^9/L
• Hemoglobin > 8.5 g/dL
• Aspartate transaminase (AST) & Alanine transaminase (ALT) < 5 x upper limit normal
• Bilirubin ≤ 2.0 mg/dL
• Albumin > 3.0 g/dL
• Creatinine < 2.0 mg/dL
• International normalized ratio (INR) ≤ 2.0
• Glomerular filtration rate (GFR) > 50
• Negative serum pregnancy test at baseline
• Life expectancy of > 3 months without any active treatment
Exclusion Criteria:

• Patients eligible for ablation or resection for their malignancy, in the opinion of the investigator, at the time of screening
• Prior systemic anti-cancer therapy (including immunotherapy and/or targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC
• Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)
• Incompetent biliary duct system, prior biliary intervention or a compromised Ampulla of Vater
• Planned localized cancer treatment to the liver, other than the study treatment, throughout the duration of the study.
• Planned systemic cancer treatment throughout the duration of the study
• Patients with portal vein thrombosis
• Patients with extrahepatic disease
• Patients with contraindications to angiography and selective visceral catheterization
• Evidence of extrahepatic collateral supply to the tumor
• Evidence of potential delivery of mean radiation dose > 30 Gy to the lungs (single treatment)
• Evidence of any detectable 99m Tc-macroaggregated albumin (99m Tc-MAA) flow outside of the liver in the abdomen, after application of established angiographic techniques to stop or mitigate such flow (e.g., placing catheter distal to gastric vessels or coiling)
• Evidence that < 33% of the total liver volume is disease-free and will be spared SIR-Spheres treatment
• Prior liver resection and/or liver transplant
• Female patients who are pregnant, breastfeeding, or premenopausal and unwilling to use an effective method of contraception through the 1-year follow-up; males unwilling to use effective method of contraception for 30 days post-procedure
• Medical history of clotting disorders
• Underlying pulmonary disease requiring chronic oxygen therapy
• Evidence of portal hypertension with ascites as seen on cross-sectional imaging or any history of prior variceal bleeding within 6 months prior to screening
• Concurrently enrolled in another study unless it is an observational, noninterventional study
• Active infection (hepatitis B (HBV) infection with ongoing HBV treatment and successfully treated hepatitis C infection are allowed)
• History of other cancer with current active treatment
• Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator
• History of severe allergy or intolerance to contrast agents, narcotics, or sedatives
• Any condition that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
Device: Resin microspheres containing yttrium-90 (Y-90)
Unresectable Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma
Unresectable hepatocellular carcinoma, HCC, Unresectable metastatic liver tumor, SIR-Spheres microspheres, Y-90 resin microspheres, Barcelona Clinic Liver Cancer, BCLC, SIRT (Selective Internal Radiation Therapy), Liver cancer
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MT2017-45 :Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients with Hematologic Malignancies

This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. The study provides criteria for consistent treatment and management according to FDA labelling of CAR-T products and does not contain experimental components. Patients will be assigned to Arms A B and C based on age, CAR-T product and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arms A B and C separately.

Veronika Bachanova, MD
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT03642626
STUDY00004096
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ARM A: Kymriah for Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19
Inclusion Criteria:

• Age and Disease Status
• Must be age 0-25 years
• Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these:
• Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or
• Patients with persistent minimal residual disease (MRD >0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or
• Patients in 2nd or greater relapse of B-ALL or
• Patients with persistent CNS leukemia, or
• Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or
• Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory.
• Performance Status
• Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50% at screening
• ALC >500/uL at screening (prior to apheresis) and absolute lymphocyte count >/= 150/uL
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as: ** ALT ≤ 5 times the ULN for age (unless due to disease) ** Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤
• 5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Other Inclusion Criteria
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
• CNS 2A
• CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment.
• Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1 ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma
Inclusion Criteria:

• Age and Disease Status
• Adult patients (age ≥ 18 years)Patients must be ≥18 years of age
• One of the following histologies and expression of CD19 by tumor cells: ** diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or ** primary mediastinal large B-cell lymphoma, or ** high grade B-cell lymphoma, or ** DLBCL arising from follicular lymphoma
• Disease status: ** Chemotherapy refractory disease after ≥2 lines of chemotherapy, or ** Relapsed with no remission after ≥1 lines of salvage chemotherapy, or ** Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy
• Measurable disease at time of apheresis: Nodal lesions or extranodal lesion
• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Renal function defined as: ** A serum creatinine of ≤1.5 x ULN OR ** eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection (controlled HIV is permissible)
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe. ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma
Inclusion Criteria:

• Age and Disease Status
• Adult patients (age ≥ 18 years)
• with relapsed or refractory (r/r) large B-cell lymphoma, including
• diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
• high grade B-cell lymphoma
• and DLBCL arising from follicular lymphoma.
• Disease status:
• after two or more lines of systemic therapy or
• relapse after autologous HCT
• Performance Status
• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m^2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)
• Other Inclusion Criteria
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active or inactive HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma
Inclusion Criteria:

• Age and Disease Status * with relapsed or refractory (r/r) mantle cell lymphoma, including
• prior anthracycline or Bendamustine containing therapy
• prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb)
• not a candidate or relapse after autologous HCT
• active disease at enrollment
• Performance Status *ECOG performance status 0-1
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
• Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other
Inclusion Criteria:

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
• Patient has taken one of the prohibited concomitant medications within the timeframe
Drug: KYMRIAH, Drug: YESCARTA, Drug: Fludarabine 30mg/m2 4 doses, Drug: Cyclophosphamide 500 mg/m2, 2 doses, Drug: Fludarabine 30mg/m2 3 doses, Drug: Cyclophosphamide 500 mg/m2, 3 doses, Drug: Fludarabine 25mg/m2 3 days, Drug: Cyclophosphamide 250 mg/m2, 3 days, Drug: Tecartus
Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
ALL, CAR-T, CAR19-T, chimeric antigen receptor T cells, Clinics and Surgery Center (CSC)
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Characterization of Comorbid Post-traumatic Stress Disorder and Major Depressive Disorder Utilizing Ketamine as an Experimental Medicine Probe

Note: The Minneapolis Veterans Affairs (VA) Health Care Systems (MVAHCS) Institutional Review Board (IRB) will oversee this research study under the main protocol (#VAM-18-00364). This local protocol addendum addresses neuroimaging at the University of Minnesota Center for Magnetic Resonance Research (UMN CMRR). Please note that we have selected "No" to the Drugs question in ETHOS, as the VA IRB approval covers the Ketamine use; only neuroimaging at CMRR is included in the UMN IRB portion of this study.

Cristina Albott
NA
This study is also accepting healthy volunteers
NCT04032301
STUDY00007264
Major Depressive Disorder, Post-Traumatic Stress Disorders
adjuvants, anesthesia, analgesics, anesthetics, anesthetics, dissociative, anesthetics, general, anesthetics, intravenous, anxiety disorders, behavioral symptoms, central nervous system agents, central nervous system depressants, depression, depressive disorder, depressive disorder, treatment-resistant, excitatory amino acid agents, excitatory amino acid antagonists, hypnotics and sedatives, ketamine, mental disorders, molecular mechanisms of pharmacological action, mood disorders, neurotransmitter agents, peripheral nervous system agents, pharmacologic actions, physiological effects of drugs, psychotropic drugs, sensory system agents, stress disorders, post-traumatic, stress disorders, traumatic, therapeutic uses
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Ida-Arlaine Fonkoue
18 Years and over
NA
This study is also accepting healthy volunteers
PMR-2021-30243
STUDY00014457
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Inclusion Criteria:
In addition to age and sex, other key inclusionary criteria are pre-menopausal and must have experienced a past trauma with or without PTSD Diagnosis.
Exclusion Criteria:
In addition to age and sex criteria, other exclusionary criteria are pregnant or breastfeeding; severe traumatic brain injury, hypertension, diabetes, heart disease, or vascular disease; illicit drugs within the past 6-months prior to participation; and inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3.
Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison. Diabetes is a known complication of acute pancreatitis. Diabetes can last a few weeks after acute pancreatitis and get better. Diabetes may not improve after acute pancreatitis. It can also appear a year or more after acute pancreatitis. Little data is available on diabetes after acute pancreatitis. This study will help us better understand diabetes after acute pancreatitis and who is at increased risk of developing it, as well as the different types of diabetes. We are asking participants to take part in this research study who have recently had an acute pancreatitis attack. Participants may be on this study for up to 5 years. There is a screening/enrollment visit, a metabolic visit and 5 year follow-up period. If you had diabetes before your acute pancreatitis attack, your study participation will end after the enrollment visit. If you did not have diabetes before your acute pancreatitis attack, you will return to the clinic for up to 6 more visits. An additional two visits can be done either at the clinic or by phone. If you are diagnosed with diabetes during the follow-up period, you will be asked to come in for an additional visit.

Melena Bellin
NA
PEDS-2021-29897
STUDY00013389
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Electronic Platform for Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long&#8208;Acting Growth Hormone Therapy (LAuGH TRACK UMN) (LAuGH TRACK)

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller, MD, PhD
All
up to 18 Years old
NA
This study is NOT accepting healthy volunteers
NCT04938466
STUDY00011784
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Inclusion Criteria:

• Girls must be between the ages of 2 and 11 years, and boys must be between the ages of 2 and 13 years
• Have established diagnosis of pediatric growth hormone deficiency (GHD). For the purposes of the study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of <10 ng/mL
• Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance
Exclusion Criteria:

• Any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
• Current treatment with long-acting growth hormone
• Currently pregnant or breastfeeding
Drug: Long-Acting Growth Hormone (LAGH)
Growth Hormone Deficiency, Growth Hormone Treatment, Children's Health, Diabetes & Endocrine
Growth Hormone Deficiency
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Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

Ian Ramsay
All
18 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02085421
1311M45305
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Inclusion Criteria:

• Meet diagnostic criteria for schizophrenia or schizoaffective disorder
• Are age 18-64
• Fluent in written and spoken English
• Have an outpatient status of at least 1 month prior to participation
• Has been on a stable dose of psychiatric medication for at least one month prior to participation
Exclusion Criteria:

• History of seizures or epilepsy
• Metallic cranial plates, screws, or implanted devices
• History of craniotomy
• History of stroke
• History of eczema on scalp
• Pre-existing sores or lesions at sites of tDCS electrode placement
• Non removable facial piercings
• Current or possibility of current pregnancy
• Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months
Device: tDCS
Psychosis
tdcs, neuromodulation, CRT, psychosis, schizophrenia
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Development of the upper limb motor scale Awareness of Functional tasks with Arm and hand in Stroke (AFAS) (AFAS)

There are 3 objectives in this study: • Reliability of AFAS • Impact of relaxation breathing and patient perception on spasticity and movement of the upper limb • Validity of AFAS

Ann Van de Winckel
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03328468
STUDY00000821
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Inclusion Criteria:

• Females and males ages 18-99 years of age
• People with stroke who are medically stable with one or more ischemic or
• hemorrhagic stroke(s)
• left or right hemiplegia
• willing and able to attend a one-time behavioral testing session
• willing and able to sign consent to participate
• able to hear, read and comprehend instructions given during the study
• English speaking (or willing to work with a (student) translator)
Exclusion Criteria:

• cognitive impairment (Mini-mental State Exam-brief version, <13/16)
• contractures in the tested arm that would hinder testing arm movements
• adults lacking capacity to consent
• severe neglect, aphasia, apraxia
• other medical conditions that preclude participation
Other: Breathing Exercise
Stroke
Stroke
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Effects of cystic fibrosis and cystic fibrosis related diabetes on brain structure and cognitive function

This is an observational cohort study in which patients with cystic fibrosis and healthy controls will undergo one research MRI to test cognitive function and map brain structures.

Amir Moheet
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03820349
STUDY00002606
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Inclusion Criteria:
patients with Cystic fibrosis
Exclusion Criteria:

• History of stroke
• History of epilepsy
• History of neurosurgical procedures
• Past or current history of severe psychiatric illness
• Pass or current history of alcohol or substance abuse
• Presence of metallic substances in body or inability to remove before imaging procedure
• History of claustrophobia or known inability to tolerate MRI
• Current pregnancy
• Inability to consent
Cystic Fibrosis
CFRD, Cystic fibrosis
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The use of hydradermabrasion in the scalp to improve scalp health and improve outcomes in androgenetic alopecia

This study aims to ovaluate the effect of hydradermabrasion for scalp health in patients with androgenetic alopecia, G1 to G4 according to Hamilton Norwood Classification with trichoscopic investigation.

Ronda Farah
18 Years and over
NA
This study is NOT accepting healthy volunteers
DERM-2021-30436
STUDY00014421
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Inclusion Criteria:
Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization Healthy men and women, ages 18 ? 45 years of age Participants who understand the study and can follow study instructions and are willing to attend the required study visits Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs. Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
Exclusion Criteria:
Participants who have an active or known skin inflammation or infection within the treatment area. Participants who have an active or known acute skin allergies Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy. Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. Immunosuppression Participants who are HIV+ / Hepatitis B + / Hepatitis C+ Participants who have been diagnosed or have a known history of any hematopathology disorders Participants who have been diagnosed or have a known history of haemostasis disorders Participants who have been diagnosed or have a known history of an autoimmune diseases Participants who are undergoing chemotherapy Participants with a history of any skin cancer on the scalp Participants who have had skin biopsy or procedure on scalp in last month Participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area Non-English speakers
Androgenetic Alopecia, Hair Loss, Hydradermabrasion, Male and Female Pattern Hair Loss, Scalp
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ExtracorPoreal FILtration of Subarachnoid Hemorrhage via SpinaL CAtheteR EXTension (PILLAR-XT)

Andrew Grande
All
18 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03607825
STUDY00004703
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Inclusion Criteria:

• Modified Fisher Grade 2, 3 or 4
• Hunt & Hess I-IV
• First aneurysmal SAH
• Patient is ≤ 48 hours post bleeding event
• World Federation of Neurosurgeons (WFNS) Grades I-IV
Exclusion Criteria:

• Pregnancy
• Patients with a SAH due to mycotic aneurysm or AV malformation
• Patients who present with an acute MI or unstable angina
• Imaging demonstrates supratentorial mass lesions > or = 15 cc
• Imaging demonstrates > or = 2 mm of mid-line-shift associated with infarction and or edema
• Effacement of the basilar cisterns
• Vasospasm on admission as defined by angiographic evidence
• Patients with a coagulopathy that cannot be reversed
• Thrombocytopenia def. platelet count < 100,000
• Patients on low molecular weight heparin such as Lovenox
• Non-communicating Obstructive hydrocephalus
• Existing hardware that prevents accurate CT imaging
• Pre-existing Lumbar Drain
• Local skin infections or eruptions over the puncture site
• Signs of CNS systemic infection, sepsis or pneumonia
Device: Neurapheresis System
Subarachnoid Hemorrhage
aneurysmal
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Scott Cooper
All
22 Years to 85 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03021031
1611M00822
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Inclusion Criteria:

• Age 22-85 years
• Diagnosis of Parkinson's disease
• Candidate for DBS
Exclusion Criteria:

• Other significant neurological disorder
• Diagnosis of dementia
• Prior history of stereotactic neurosurgery for treatment of Parkinson's disease, tremor, or dystonia.
• Pregnant women
Other: Observational
Parkinson Disease
Parkinson's Disease, Clinics and Surgery Center (CSC)
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Antiplatelet Removal and HemocompatIbility EventS with the HeartMate 3 Pump (ARIES HM3)

The clinical investigation objective is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS.

Rebecca Cogswell
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04069156
STUDY00009255
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Inclusion Criteria:

• Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
• Subject will receive the HeartMate 3 as their first durable VAD.
• Subject must provide written informed consent prior to any clinical investigation related procedure.
• In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
Exclusion Criteria:

• Post-implant additional temporary or permanent mechanical circulatory support (MCS).
• Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
• Patients who are nil per os (NPO) post-implant through day 7.
• Subjects with a known allergy to acetylsalicylic acid (aspirin).
• Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Device: LVAD Implant, Drug: Aspirin 100mg, Drug: Placebo oral tablet
Heart Failure
heart failure, ventricular assist device, LVAD, aspirin
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Randomized Clinical Evaluation of the AccuCinch? Ventricular&#13;&#10;Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Greg Helmer
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04331769
STUDY00013236
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Inclusion Criteria:

• Age 18-years or older
• Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
• LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
• Symptom Status:
• NYHA III,
• NYHA ambulatory IV, or
• NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
• Able to complete six-minute walk test with distance between 100 m and 450 m.
• Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.
• "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
• When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
• When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
• When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
• When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
• If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
• If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
• If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
• When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT
• Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule
Exclusion Criteria:
Cardiovascular
• Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization
• Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
• Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
• Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
• Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
• Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
• Active bacterial endocarditis
• Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
• Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
• History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke Valvular
• Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
• Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
• Prior mitral or aortic valve replacement
• Tricuspid regurgitation grade 4+ (severe)
• Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)
• Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural
• Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)
• Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
• Subjects in whom anticoagulation during the procedure is contraindicated
• Subjects in whom 90 days of antiplatelet therapy is contraindicated
• Known allergy to nitinol, polyester, or polyethylene
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure General
• Life expectancy <1 year due to non-cardiac conditions
• Currently participating in another interventional investigational study
• Subjects on high dose steroids or immunosuppressant therapy
• Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating
Device: AccuCinch Ventricular Restoration System, Drug: Guideline-Directed Medical Therapy
Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
Heart Failure, Reduced Ejection Fraction, Cardiomyopathy, Clinics and Surgery Center (CSC)
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Britt Erickson
Female
35 Years to 50 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04251052
STUDY00012693
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Inclusion Criteria:

• Women 35-50 years of age, inclusive
• Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
• At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and tube are present
• Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
• Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable. Concurrently planned hysterectomy with salpingectomy for the BS group or with BSO for the BSO group is permitted
• Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:

• Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
• Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
• Patients medically unfit for the planned surgical procedure
• Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
• An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
• An abnormal CA-125 is defined as a level > 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives
• Women who are currently pregnant or plan to become pregnant in the future
Procedure: Bilateral Salpingectomy, Procedure: Bilateral Salpingectomy with Oophorectomy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Ovarian Carcinoma
Clinics and Surgery Center (CSC)
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Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (DELIVER-MS) (DELIVER-MS)

The DELIVER-MS study seeks to answer the important question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.

William Schmalstieg
All
18 Years to 60 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT03535298
STUDY00004712
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Inclusion Criteria:

• Men and women aged 18 to 60 years.
• Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
• RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
• Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening [compared to a previous recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
• Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
• Participants must be eligible to receive at least one form of DMT within each treatment arm.
• EDSS at Baseline visit ≤ 6.5
Exclusion Criteria:

• Participants with contraindications to all forms of DMT in either of the treatment arms.
• Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
• Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
• Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
• Participants unable to provide informed consent.
• Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
• Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
Drug: Early Highly Effective Therapies Group, Drug: Escalation Therapies Group
Multiple Sclerosis, Relapsing-Remitting
Clinics and Surgery Center (CSC)
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Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting

A multi-center, prospective, randomized controlled study employing an adaptive design study for interim sample size re-estimation. Objectives: -Demonstrate that PCI guided by iFR Co-registration is associated with superior clinical outcomes compared to PCI guided by angiography alone -To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI strategy -To establish the relationship between physiological guidance and improvement in associated angina and quality of life scores -To examine the outcomes in patients in whom an optimized post-PCI iFR can versus cannot be achieved

Greg Helmer
NA
This study is NOT accepting healthy volunteers
NCT04451044
STUDY00013653
Coronary Artery Disease, Ischemic Heart Disease
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors&#13;&#10;for Stroke Prevention and Recovery (ASPIRE)

Oladi Bentho
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03907046
STUDY00008045
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Inclusion Criteria:

• Age at least 18 years
• Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
• Can be randomized within 14-180 days after ICH onset
• Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
• CHA2DS2-VASc score ≥ 2
• Provision of signed and dated informed consent form by patient or legally authorized representative
• For females of reproductive potential: use of highly effective contraception
Exclusion Criteria:

• Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
• History of earlier ICH within 12 months preceding index event
• Active infective endocarditis
• Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent MI).
• Previous or planned left atrial appendage closure
• Clinically significant bleeding diathesis
• Serum creatinine ≥2.5 mg/dL
• Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
• Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) that is chronic in the judgment of the investigator
• Pregnant or breastfeeding
• Known allergy to aspirin or apixaban
• Concomitant participation in a competing therapeutic trial
• Considered by the investigator to have a condition that precludes safe or active participation in the trial
• Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
Drug: Apixaban, Drug: Aspirin
Intracerebral Hemorrhage, Atrial Fibrillation
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Immunosuppression reduction in failed allograft guided by cfDNA

The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

Samy Riad
NA
This study is NOT accepting healthy volunteers
NCT04560582
STUDY00004458
Kidney Transplant Failure, Kidney Transplant Rejection, Kidney Transplant, Complications
Clinics and Surgery Center (CSC)
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MT2019-35: NeurotoxicityProphylaxis with Intrathecal Dexamethasone and Simvastatin in Adults Receiving AxicabtageneCiloleucel (Axi-Cel) Treatment

This study is designed to determine the feasibility of administration, safety and tolerability of IT dexamethasone and simvastatin therapy in patients receiving axi-cel therapy while providing preliminary estimates of efficacy.

Joseph Maakaron
All
18 Years to 80 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04514029
STUDY00009175
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Inclusion Criteria:

• 18- 80 years of age
• One of the following histologies:
• Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
• Primary mediastinal B-cell lymphoma, or
• High grade B-cell lymphoma, or
• DLBCL arising from follicular lymphoma
• Disease status:
• Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
• Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
• Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy
• Performance Status
• ECOG performance status 0-2
• Adequate organ function defined as:
• Renal function defined as:
• eGFR ≥ 30 mL/min/1.73 m^2
• Liver function defined as:
• ALT and AST ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
• Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol.
• Able to provide written voluntary consent (or LAR consent for adults with diminished capacity) prior to the performance of any research related tests or procedures
• Availability of a certified practitioner to perform the lumbar punctures
Exclusion Criteria:

• Allergies, or intolerance to simvastatin or dexamethasone
• Already receiving a statin drug for hypercholesterolemia and unwilling to change medication to 40 mg/day of simvastatin
• Active uncontrolled CNS lymphoma. Patients with history of CNS lymphoma who have been adequately treated are eligible
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD).
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection
• Unstable angina and/or myocardial infarction
• Risk factors that preclude a safe lumbar puncture (high intracranial pressure, bleeding diathesis that cannot be reversed or corrected, need for uninterrupted anticoagulation, platelets < 50K that cannot be corrected with transfusional support
• Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration.
Drug: Simvastatin, Drug: Dexamethasone
Lymphoma
Lymphoma, CAR-T, Neurotoxicity, CRS, Dexamethasone, Simvastatin, Clinics and Surgery Center (CSC)
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MT2021-01: PTCy + Sirolimus/VIC-1911 as GVHD prophylaxis in myeloablative PBSC transplantation

The primary objective of this study is to determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.

Shernan Holtan
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05120570
STUDY00015049
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Inclusion Criteria:

• Diagnosis of
• acute leukemia in complete remission, or
• myelodysplasia with <5% blasts, or
• myeloproliferative neoplasm/myelofibrosis with <5% marrow or circulating blasts
• chemosensitive Hodgkin or non-Hodgkin lymphoma
• Age 18 years or older
• Performance status of ≥ 80% Karnofsky
• Adequate organ function within 28 days of study registration defined as:
• left ventricular ejection fraction ≥ 45%
• pulmonary function with FEV1, FVC, and DLCO ≥ 50% predicted
• AST and ALT < 2 times upper limit of normal
• Total bilirubin <1.5 times the upper limit of normal. If the patient is suspected of having Gilbert syndrome, they require prior approval of the medical monitor
• creatinine clearance ≥ 50cc/min
• no active/uncontrolled infection
• negative HIV, HBV and HCV
• ferritin < 2000 ng/ml
• Patients able to tolerate oral medication
• Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment through 60 days after the last treatment of VIC-1911 or sirolimus
• Able to provide written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:

• HCT-CI > 4 or unable to receive myeloablative TBI
• Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day +75 or later
• Patients with a history of hypersensitivity to any of the investigational products
• Pregnant or breastfeeding as agents used in this study are Pregnancy Category o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration.
• Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus
Drug: VIC- 1911
Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Lymphoma
VIC-1911, PTCy, Myeloablative, Allogeneic, Clinics and Surgery Center (CSC)
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Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'

The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.

Stephen Hecht, PhD
18 Years and over
NA
This study is also accepting healthy volunteers
2009NTLS059
0908M70881
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Inclusion Criteria:

• 21 years or older
• Daily user of tobacco or nicotine products
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Cancer, Community Health, Prevention & Wellness
nicotine, nicotine replacement, smokeless tobacco, smoker, smoking, tobacco, vaper, vaping
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Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

This study will examine the effects of non-invasive, transcranial electric stimulation (TES) on neural activity during a cognitive task or rest using invasive recordings in patients undergoing phase II epilepsy monitoring.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04680481
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Inclusion Criteria:

• the patient can consent for themselves;
• the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation;
• age 18+ years old;
Exclusion Criteria:

• diminished capacity to consent;
Device: Transcranial alternating current stimulation
Working Memory
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