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366 Study Matches

Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients undergoing Sevoflurane Anesthesia

Study is to investigate the relationship between Bispectral Index (BIS) values including EEG profile and anesthetic agents in the pediatric population.

Benjamin Kloesel
up to 18 Years old
Pivotal
ANES-2021-30290
STUDY00014663
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Inclusion Criteria:
-Pediatric Subjects aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
Exclusion Criteria:
-severe contact allergies -Known neurological disorder -Severe developmental delay -Airway abnormalities -Pregnancy -Taking psychoactive medications
• Taking any medications that may have an impact on the Central Nervous System
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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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Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.

Karina Quevedo
up to 18 Years old
NA
This study is NOT accepting healthy volunteers
PSYCH-2020-29400
STUDY00012895
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Inclusion Criteria:
Targeted Sex: Both female and male (at birth). Gender identity = any.; Age group: 11-17 years old; Inclusion: past suicide attempt and/or current suicide ideation.
Exclusion Criteria:
Autism/ Asperger/autism Spectrum Disorder; Cognitive Developmental Delay (IQ < 75 i.e. Mental Retardation); Schizophrenia
Brain & Nervous System, Children's Health, Mental Health & Addiction
adolescents, mental health, self-harm, suicidal, suicide attempt, suicide ideation, teen brain train
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Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Melanie Nicol
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03218085
1610M98383
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Inclusion Criteria:

• Female, or transgender female with a cervix, age 18 years or older
• HIV-positive
• Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
• Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
• Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
• Willing and able to give signed informed consent.
Drug: Tenofovir, Drug: Emtricitabine
HIV/AIDS, Menopause, Inflammation Vagina
tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation, pharmacology
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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:

• Age 18-80
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:

• 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
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Clinics and Surgery Center (CSC), Lung, Pulmonary, Sarcoidosis
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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
18 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, Bone, Joint & Muscle, Brain & Nervous System
Pain, Spinal Cord Stimulation
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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 10^3/µL ii. Hemoglobin < 10 gm/dL iii. Hematocrit < 30% iv. WBC > 20 x 10^3/µL v. Neutropenia (ANC < 1.5 x 10^3/µL) vi. Lymphopenia (absolute lymphocyte count < 1.5 x 10^3/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 or patients who have developed a new lesion following one of these prior locoregional treatments:
• Liver resection with negative pathologic margins, no microvascular invasion, and no recurrence at resection margins for at least 6 months post-treatment and no new lesions within 6 months of liver resection
• Ablation of a single ≤3cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment
• 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 ≥1 cm in diameter (long axis) measured according to mRECIST criteria by CT or MRI
• Child-Pugh score of A5 or A6 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
• 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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NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries (EXPEDE)

This study will investigate how safe and how effective or well the investigation drug, NEXAGON, is for healing corneal persistent epithelial defects or PEDs

All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT04081103
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Inclusion Criteria:

• Male and female of any age.
• The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
• The PED is non-responsive to current standard of care for at least 14 days from injury.
• The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
• Providing written informed consent and ability to comply with the visit and dosing schedule.
Exclusion Criteria:

• Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
• Have active ocular infection.
• Subjects with corneal perforation or impending corneal perforation.
• Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
• Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
• Subjects being treated with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days prior to Day 1.
• Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
• Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
• Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Drug: Nexagon® (lufepirsen) High Dose Concentration, Drug: Nexagon® (lufepirsen) Low Dose Concentration, Drug: Vehicle, Drug: Open-label Nexagon® (lufepirsen)
Corneal Persistent Epithelial Defect
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Prescribing Interventions for Chronic Pain via the Electronic Health Record (PRINCE) (PRINCE)

A clinic-randomized study of behavioral economics-inspired "nudges" build into the the electronic health record system, with the goal of improving opioid prescribing decisions.

Ezra Golberstein
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601506
STUDY00006522
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

Regular participation in physical activity helps maintain a healthy weight, improves energy levels and overall health. Children and teenagers who have received treatment for cancer are often less active, may gain weight and have more health problems as compared to children and teenagers who have not received treatment for cancer. This study looks at physical activity and its effect on your health. This study will use a variety of interventions to see if they affect how active you are over time.

Lucie Turcotte
All
8 Years to 16 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03223753
STUDY00004806
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Inclusion Criteria:

• All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission
• Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 months at a Childrens Oncology Group (COG) institution
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age
• At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week
• Patient and at least one parent/guardian are able to read and write English, Spanish, and/or French; at least 1 parent/guardian must be able to read and write English, Spanish, and/or French in order to assist the patient with using their physical activity tracking device account
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with previous hematopoietic stem cell transplant (HSCT)
• Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
• Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test
• Female patient who is postmenarcheal and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation
• Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g. unresolved posterior fossa syndrome) are not eligible
Other: Educational Intervention, Other: Internet-Based Intervention, Other: Internet-Based Intervention, Other: Laboratory Biomarker Analysis, Device: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
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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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MT2021-29: Evaluation of intravenous laronidase pharmacokinetics before and after hematopoietic cell transplantation in patients with mucopolysaccharidosis type IH.

This is a prospective, observational multicenter study to collect blood from patients with mucopolysaccharidosis type IH (MPS-IH) undergoing laronidase therapy and a stem cell transplant.

Paul Orchard
NA
NCT05634512
STUDY00016560
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (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
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT05197920
STUDY00013389
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Inclusion Criteria:

• Diagnosis of acute pancreatitis (AP) 0-90 days prior to enrollment date
• Participant fully understands and is able to participate in all aspects of the study, including providing informed consent, completion of case report forms (CRFs), telephone interviews, metabolic testing, and planned longitudinal follow-ups
Exclusion Criteria:

• Diagnosis of definite chronic pancreatitis (CP) at enrollment based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP): (a) Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular); (b) Intraductal filling defects suggestive of calcifications on MRI and/or MRCP
• Potential participants with post-endoscopic retrograde cholangiopancreatography (post- ERCP) AP who are hospitalized for <48 hours.
• Prior (i.e., before enrollment) direct endoscopic necrosectomy of the pancreas or percutaneous necrosectomy or drainage of necrotic collection(s). Participants who require this during follow-up will remain in the study
• Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis
• Confirmed or suspected cystic tumor associated with main pancreatic duct dilation, or believed to be the cause of AP (in the site-PI's judgement)
• Prior pancreatic surgery, including, but not limited to: distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, Frey procedure
• Use of disallowed concomitant medications within 30 days prior to enrollment. A comprehensive list of disallowed medications will be included and routinely updated in the study's Manual of Procedures
• Severe systemic illness that in the judgement of the investigative team will confound outcome assessments of DM and immunological outcomes or pose additional risk for harms, including: history of solid organ transplant, acquired immunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with estimate glomerular filtration rate (eGFR) < 30 or on dialysis prior to AP, and cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of <12 months.
• Known pregnancy at the time of enrollment. Participants who become pregnant during follow-up will remain in the study, but may have modified study assessments for safety
• Incarceration
• Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study
Acute Pancreatitis, Diabetes & Endocrine, Digestive & Liver Health
Diabetes
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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
18 Years and over
NA
This study is NOT accepting healthy volunteers
PEDS-2021-29897
STUDY00013389
Diabetes & Endocrine, Digestive & Liver Health
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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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Biomechanical Mechanisms of Soft Tissue Deformation during the Volleyball Spike

No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.

Paula Ludewig
18 Years and over
NA
This study is also accepting healthy volunteers
PMR-2022-30925
STUDY00015763
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Inclusion Criteria:
between 18-35 years of age; play competitive volleyball at the club level (committed to collegiate participation) or NCAA D3 level or above; fluent in English; have no shoulder pain that limits volleyball participation; have a negative clinical screening exam; able to provide informed consent
Exclusion Criteria:
any injuries, impairments, or pain of the dominant (hitting) upper extremity that limit participation in volleyball; shoulder pain found to be related to the cervical spine; have a history of trauma and/or surgery of the hitting shoulder; or are currently pregnant.
Bone, Joint & Muscle
Volleyball, athlete, shoulder, spike mechanics
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Dissecting the role of acetaldehyde in oral carcinogenesis

The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, in order to identify DNA damage that might be crucial to cancer formation.

Silvia Balbo
18 Years and over
NA
This study is also accepting healthy volunteers
SPH-2021-29712
STUDY00012972
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Inclusion Criteria:

• 21 years of age or older
• occasional or regular alcohol drinker
• Experiences flushing (reddening or warming of face) when you drink OR have Fanconi Anemia
Exclusion Criteria:

• Tobacco or nicotine users
Alcohol, Fanconi Anemia, drinking
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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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Traveling-wave Transcranial Electric Stimulation (TravelingTES)

This is a non-invasive brain stimulation study in healthy, adult volunteers that will examine the electrophysiological and behavioral effects of dual-site transcranial alternating current stimulation (TACS).

All
18 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT05399381
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Inclusion Criteria:

• Age between 18 and 45 years old.
• Confident level of English language.
Exclusion Criteria:

• History or evidence of chronic neurological or mental disorder.
• Metal or electric implant in the head, neck, or chest area.
• History of head injuries with loss of consciousness.
• Any acute or chronic medical condition that requires ongoing pharmacological treatment.
• Pregnancy or breast-feeding.
• Alcohol or drug addiction.
Device: Transcranial alternating current stimulation (tACS)
Working Memory
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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
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03021031
1611M00822
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Inclusion Criteria:

• Age 18 years and older
• 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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The efficacy of incobotulinum toxin A injections for treatment of tinnitus: a randomized controlled trial

This study is a double blinded crossover clinical trial evaluating the safety and effectiveness of incobotulinum toxin A or a placebo (before crossover) injections for the treatment of tinnitus.

Stephanie Standal
Phase II
PMR-2021-29462
STUDY00011665
Ear, Nose & Throat
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