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596 Study Matches

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In Vivo Development of Sodium Magnetic Resonance Imaging Technology

Sodium MRI Pilot

Timothy Kline
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
0000-123006-H01-RST
19-012099
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Inclusion Criteria:

  • Men and women.
  • Ages ≥ 18 to ≤ 65 years old.
  • Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
  • Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).


Exclusion Criteria:

  • No contraindication to MRI.
  • No implanted devices within the body (shunts, clips, plates, etc.).
  • No dental braces or retainer wires.
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Mayo Clinic — Rochester, MN

The Use of Virtual Reality Modules to Reduce Pre-Operative Anxiety in a Cardiac Surgery Inpatient Population

Healium Virtual Reality Protocol

Jordan Miller
All
21 years to 80 years old
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
0000-123015-H01-RST
19-012262
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Inclusion Criteria:

  • Able to understand the goals of the study and provide informed consent.
  • Any hospitalized patient scheduled for a first time sternotomy under the care of Mayo Clinic cardiovascular inpatient service or thoracic inpatient service admitted after 1 February 2020, who is not excluded due to criteria listed below.
  • Between the ages of 21 and 80 years old.
  • English speaking.


Exclusion Criteria:

  • Unable to consent to study due to cognitive difficulty.
  • Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of virtual reality (VR) hardware and software.
  • Sensitivity to flashing light or motion.
  • Patients who received anxiolytic drugs or sedatives within the preceding 24 hours.
  • Recent stroke.
  • Post-transplant patient, or pre-transplant patient with severe illness.
  • At the time of in-room virtual reality (VR) administration, patient on ventilator, is receiving BiPAP or CPAP, or other breathing assistance equipment.
  • Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face).
  • Non-English speaking.
Behavioral, Device
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Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (EPAS)

A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

Brian Lundstrom
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123016-P01-RST
19-012307
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Inclusion Criteria:

  • Focal (partial) onset seizures that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video electroencephalogram (EEG) that captured at least one ictal event.
  • Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase.
  • Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness.
  • Age 18 or older at the time of enrollment.
  • Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff.
  • Able to use the Patient Programmer with or without the assistance of a caregiver.
  • Ability of the subject or legal representative to understand and provide signed consent for participating in the study.
  • Willing and available to attend visits as scheduled and to comply with the study protocol.


Exclusion Criteria:

  • Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification).
  • Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary.
  • Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit.
  • Previous diagnosis of psychogenic/non-epileptic seizures.
  • Surgical candidate for and willing to undergo resective surgery.
  • Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas).
  • Diagnosed with a progressive or degenerative neurological disorder affecting the brain.
  • Significant medical condition that may impact study participation in the opinion of the investigator.
  • Presence of any of the following within 1 year prior to the Enrollment Visit:
    • psychiatric illness hospitalization;
    • suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state;
    • a post-ictal state or a medication.
  • Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas).
  • Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators (VNS) are allowed if the subject agrees to have the device turned off for at least 30 days after signing the informed consent and prior to the Enrollment Visit assessments. The VNS generator needs to be explanted prior to or at the time of the DBS neurostimulator implant.
  • Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. This includes administration of any antiplatelet or anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use, chronic aspirin use of greater than 325 mg/day, and any participant with a history of hemorrhagic stroke.
  • History of drug or alcohol abuse within the past year.
  • Condition or disease that is known to require repeat magnetic resonance imaging (MRIs).
  • Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team.

Implant Criteria:

To continue to implant, the data at the end of the CMM Phase must demonstrate that the subject meets these additional inclusion criteria, in addition to verifying the initial eligibility criteria above:

  • Experienced an average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 days between seizures.
  • Completed at least 70 days of diary information during CMM phase.
  • Completed 3-month CMM visit.
  • Has Beck Depression Inventory II (BDI-II) score < 20 at 3-month CMM visit and no suicide attempt or other self-harm behaviors within past year (assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) at 3-month CMM visit).
  • If female, has a negative pregnancy test and if sexually active continues using a reliable form of birth control, is surgically sterile, or is at least 2 years post-menopausal.
Device, Deep brain stimulation
Epilepsy, Seizure
Deep brain stimulation, Localization-related epilepsy, Nervous system, Tonic-clonic epilepsy
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Mayo Clinic — Rochester, MN

Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery - ENCASE II (ENCASE II)

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE II)

Jamie VanGompel
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123018-P01-RST
19-012327
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Inclusion Criteria
•Pre-operative:

  • Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
  • Subjects who are ≥ 18 years old.
  • Subjects who are able to comply with the follow-up or other study requirements.
  • Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
  • Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.

Inclusion Criteria
•Intra-operative:

  • Subjects with surgical wound classification Class I/Clean.
  • Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria
•Pre-operative:

  • Female subjects who are pregnant or breastfeeding.
  • Subjects with an assumed impaired coagulation due to medication or otherwise.
  • Subjects suspected of an infection requiring antibiotics.
  • Subjects with any type of dural diseases in planned dural closure area.
  • Subjects requiring re-opening of planned surgical area within 90 days after surgery.
  • Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
  • Subjects who previously received a LIQOSEAL®.
  • Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
  • Subjects with a presence of hydrocephalus.
  • Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g., knee replacement].

Exclusion Criteria
•Intra-operative:

  • Subjects in whom elevation of PEEP has a potential detrimental effect.
  • Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
  • Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
  • Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
  • Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
  • Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

Eligibility last updated 9/27/21. Questions regarding updates should be directed to the study team contact.

Device
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Prospective Assessment of Changes in Plasma Biomarkers in Patients with Gliomas Receiving Standard Therapy

A Study to Assess Metabolic Changes in the Blood with Standard Treatment in Patients with Gliomas

Sani Kizilbash
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123035-H01-RST
19-012496
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Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Patients with histopathologic or molecular confirmation of either IDH-mutant diffuse astrocytoma or IDH-mutant anaplastic astrocytoma.
  • Patients who will be proceeding to receive routine standard of care treatment (radiation with concurrent oral temozolomide) at Mayo Clinic, Rochester.


Exclusion Criteria:
 

  • Patients who have previously received any adjuvant therapy (radiation, chemotherapy, investigational) directed towards the glioma.
  • Patients who have been previously treated with Gliadel wafers.
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A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban

PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Alberto Pochettino
All
18 years and over
Phase 3, Feasibility
This study is NOT accepting healthy volunteers
0000-123036-P01-RST
19-012512
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Inclusion Criteria:

  • Male or female at least 18 years of age at the time of giving informed consent.
  • Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
  • Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
  • Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
  • Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (e.g., barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
  • Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.


Exclusion Criteria:

  • Mechanical valve in any position other than aortic valve.
  • Any cardiac surgery in the three months (90 days) prior to enrollment.
  • Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
  • Known hypersensitivity or other contraindication to apixaban.
  • On dialysis or a creatinine clearance < 25 mL/min.
  • Ischemic stroke or intracranial hemorrhage within 3 months.
  • Active pathological bleeding at the time of screening for enrollment.
  • Active endocarditis at the time of screening for enrollment.
  • Pregnant, plan to become pregnant, or are breast feeding.
  • On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
  • History of non-compliance with recommended monthly INR testing.
Device, Drug, Radiation, Coagulation factor Xa inhibitor prophylaxis, Drug therapy
Aortic valve disease, Aortic valve stenosis, Heart valve disease
Aortic valve prosthesis, Aortic valve repair and replacement, Apixaban, Cardiovascular system, Heart valve surgery, Prosthetic heart valve in situ, apixaban
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Transplant Caregiver (CG) Research Registry

Caregiver Registry

Cassie Kennedy
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123038-H01-RST
19-012536
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Inclusion Criteria:

  • Solid organ transplant candidates (18 years or older) on deferred, active, or inactive transplant waiting lists.
  • Nominated adult caregivers (18 years or older) of solid organ transplant patients listed for deceased donor solid organ transplantation.
  • CG identified in the electronic medical record.


Exclusion Criteria:

  • Individuals unwilling to provide consent.
  • Patients or CG unable to complete questionnaires or consents due to limited English proficiency.
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Development and Validation of Innovative Hybrid Molecular Imaging, 68Ga-PSMA-dual Contrast PET/MRI and 68Ga-PSMA PET/CT, to Transform the Care of Patients with Hepatocellular Carcinoma

A Study to Develop and Validate Hybrid Molecular Imaging to Transform the Care of Hepatocellular Carcinoma Patients

Ajit Goenka
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123040-P01-RST
19-012563
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Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC.
  • Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy.
  • No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm).
  • For the systemic therapy arm, patients who have had unequivocal progression after prior LRT and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.


Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC.
  • Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to PET/MRI).
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
  • Subjects with higher than the weight/size limitations of PET/MRI or PET/CT scanner.
  • Subjects with contraindication to MRI (relevant to PET/MRI):
    • Subjects who have a heart pacemaker;
    • Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain;
    • Subjects who have implanted devices with magnets;
    • Subjects who have other implanted electronic devices;
    • Subjects who have deep brain stimulator;
    • Subjects who have vagal nerve stimulator;
    • Subjects with cochlear (ear) or auditory implants.
Administration of antineoplastic agent, Biopsy of liver lesion, Liver excision, Nuclear medicine procedure, PET CT of whole body, Radiation, Excision of liver
Cancer, Hepatocellular carcinoma, Liver cancer
Cancer treatment, Chemoembolization for liver cancer, Digestive system, Gadobutrol, Gadoxetic acid [INN], Gallium Ga-68, Gallium Ga-68 gozetotide, Liver cell carcinoma, Liver transplant, Liver tumor ablation, Medical Oncology, Radioembolization for liver cancer, gadobutrol, gadoxetate, gallium, Liver resection, Gallium Ga 68 gozetotide [USAN]
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A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients with Celiac Disease

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients

Joseph Murray
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-123041-P01-RST
19-012571
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Inclusion Criteria:

  • Adults aged 18 to 80 years, inclusive.
  • Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
  • Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
  • Has followed a GFD for > 12 months immediately prior to study entry.
  • Negative for tTG and negative or weak positive for DGP-IgA/IgG during screening.
  • Male or female, and using at least 2 acceptable birth control methods or who are sterile or postmenopausal.
  • Capable of understanding and complying with protocol requirements.
  • Patient understands and has signed the informed consent form.


Exclusion Criteria:

  • Refractory celiac disease.
  • Selective IgA deficiency.
  • Positive for HLA-DQ8 (DQA1*03, DQB1*0302).
  • Previous treatment with tolerance-inducing therapies for celiac disease.
  • Known wheat allergy.
  • Part B only: History of hyperacute or prolonged symptoms following gluten exposure.
  • Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation.
  • History of dermatitis herpetiformis.
  • Pregnant or breastfeeding.
Drug, Drug therapy
Celiac disease
Celiac disease, Digestive system
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Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Molly Jeffery
All
15 years and over
This study is NOT accepting healthy volunteers
0000-123046-P01-RST
19-012615
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Inclusion Criteria:

  • Age 15 and over (15+ will only occur in dental setting).
  • English- or Spanish-speaking.
  • Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed.
  • Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone.
    • We do not anticipate many opioid-naïve people receiving an opioid analgesic for acute pain will receive the following drugs, however, we will not exclude otherwise eligible patients who receive one of the following drugs: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol.
    • All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
  • Opioid naive (no use of prescribed opioids or illicit opioids, including medical or non-medical use, in the past 6 months) by self-report.
  • Willing and able to give consent and participate in study.
  • Able to access a mobile device (smartphone or tablet) with web access every day to complete study surveys.
  • Willing to connect Fitbit to a device that can regularly link to Hugo for data transfer.
  • Willing to use the health data sharing platform.
  • Released/discharged to home after their visit.


Exclusion Criteria:
 

  • Pain thought to be caused by a systemic disease very likely to progress to chronic pain (e.g., sickle cell disease, fibromyalgia, lupus, multiple sclerosis, etc.).
  • Cancer or end-of-life pain.
  • Unable to give consent and be enrolled within 3 days of their visit.

 

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Assessment of Traumatic Brain Injury with Multiparametric Magnetic Resonance Elastography

Assessment of Traumatic Brain Injury with Multiparametric Magnetic Resonance Elastography

Ziying Yin
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-123048-H01-RST
19-012651
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We propose recruiting a total of 150 subjects with ages ranging from 18 to 99 including 3 groups: (1) mTBI+/RHI+: 50 patients with diagnosed mild traumatic brain injury (mTBI) and with the history of organized contact-sports; (2) mTBI-/RHI+: 50 age (by decades) /sex-matched participants that has a history of organized contact-sports but without diagnosed mTBI; (3) mTBI-/RHI-: 50 age (by decades)/sex-matched control participants with no history of organized contact-sports and no diagnosis of mTBI. It is not anticipated that these subjects will have mild cognitive impairment (MCI) from the TBI. MCI is a syndrome defined as a cognitive decline greater than expected for an individual’s age and education level but that does not interfere with activities of daily living.

Group 1 recruitment mTBI+/RHI+:

Residents of Olmsted County, Minnesota who were diagnosed with mTBI will be identified by using the medical-records linkage system of the Rochester Epidemiology Project (REP) between 2017 and 2020. The REP indexes all medical information of individuals residing and receiving care in Olmsted County, Minnesota. Individuals will be identified if they had a diagnostic code in the medical records suggestive of a potential head injury (Table 1),then the medical records will be reviewed for the dates of the specific codes and determined whether a mTBI occurred based on the Mayo Classification System for TBI severity (Definite, Probable, and Possible). By this definition, a “Definite” TBI had to have at least one of the following: loss of conscious of ≥30 minutes, post-traumatic anterograde amnesia of ≥24 hours, intracerebral hematoma, subdural hematoma, epidural hematoma, cerebral contusion, hemorrhagic contusion, penetrating TBI (dura penetrated) or subarachnoid hemorrhage; a “Probable” TBI had to have at least one of the following: loss of consciousness of momentary to <30 minutes, post-traumatic anterograde amnesia of momentary to <24 hours, or depressed, basilar, or linear skull fracture; a “Possible” TBI had to have at least two of the following: blurred vision, confusion (mental state changes), dazed, dizziness, focal neurologic symptoms, headache, or nausea.

If the “Probably” or “Possible” TBI criteria apply to the trauma event, the event will be considered as a mTBI.

The participation of organized contact-sport will be self-reported. Potential participants will be approached with the phone script and/or the letter. If the patient expresses willingness to participate, we will send him/her the follow-up letter or email with a tentative study visit date according to his/her preference. The consent form will be enclosed with the letter/email for his/her review. The questionnaire about the history of contact-sports play will also be enclosed.

Table 1- Codes for traumatic brain injury-related emergency department visits and hospitalizations as recommended by Center for Disease Control and Prevention

Description

ICD-9-CM Codes

Concussion

850

Cerebral laceration and contusion

851

Intracranial injury of other and unspecified nature

854

Injury to optic nerve and pathways

950.1-950.3

Head injury, unspecified

959.01

Inclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Possible” or “Probably” TBI as defined above.
  2. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

 

Exclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Definite” TBI as defined above.
  2. A history of chronic neurological disease;
  3. Pregnancy or breastfeeding;
  4. Inability to provide consent.

 

Group 2 and Group 3 recruitment:

Recruitment of these paid, groups 2 and 3 participants will be conducted (1) through established Mayo Clinic Rochester research study advertisements, and (2) through Mayo Clinic Study of Aging (MCSA) that provides a list of Olmsted County, MN residents who enrolled in MCSA, from whom matched control will be drawn. The participation of organized contact-sport will be self-reported.

Inclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

Inclusion Criteria for Group 3 (mTBI-/RHI-):

  1. No history of participating in any organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 3 (mTBI-/RHI-):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

 

The 3 groups will be age- (by decades) and sex-matched. We will start by recruiting the 3 groups together for the efficiency of data collection. During the recruitment process, if we notice a certain age range or sex is lacking, we will focus on targeting this particular age group or sex group to ensure the maximum matching. For example, if we particularly looking for 18-25-year-old male volunteers with no history of contact-sports participation in group 3, we will have a 2nd advertisement focusing on this particular age group and/or sex group.

 

Remuneration of $75 will be provided for each participant. If the participant were asked to return for additional imaging, remuneration of $75 will be provided for each visit.

 

All subjects will be carefully screened by MRI personnel to be certain that they do not have any contraindication to an MRI exam such as foreign bodies in the brain or eye or an incompatible device such as a cardiac pacemaker. This safety screening is part of the routine clinical practice and is performed before any subject is permitted to enter the scanning room. The patients and parents will be given the option of withdrawing from the study at any point in the project without jeopardizing their medical care at Mayo Clinic. Patients requiring sedation to complete the MRI will be excluded from the study.

 

Pregnant or nursing women are not eligible to participate in this study.  If the participant wishes to participate with the study she will be asked about her pregnancy status.  If she thinks she may be pregnant or if she is unsure of her pregnancy status, she will be offered a no-charge urine pregnancy test before proceeding with any study visit imaging.

 

We will attempt to recruit an equal number of men and women, but the final proportions will be dependent upon the available subjects in the disease group. Although we will make every effort to include minority subjects, most of the subjects enrolled in Rochester will be of Caucasian background which is a reflection of the regional demographics.

 

If there is a question on whether or not the subject has the capacity to provide informed consent, the investigator or a member of the study team will assess the patient by reviewing questions regarding the study such as:

  1. Can you tell me the purpose of this study?
  2. Do you have to be in this study?
  3. Can you tell me what will happen if you agree to take part in this study?
  4. What will happen to you if you choose not to be in the study?

 

If it is determined that the subject does not have the capacity to provide informed consent, the subject will then be excluded from the study.

 

The investigator or coordinator will meet with the potential participants in a private consult room to review and discuss the details of the study using the informed consent document as a guide. The discussion will include all of the elements of informed consent. Potential participants will be given an opportunity to ask questions and we be provided a copy of the informed consent document.

Concussion, Head injury, Sports injury, Traumatic brain injury, Traumatic injury
Concussion injury of brain, Injury while engaged in sports activity, MRI, Magnetic resonance elastography, Musculoskeletal system, Nervous system
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A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease (PIANO)

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Sunanda Kane
Female
0 years to 45 years old
This study is NOT accepting healthy volunteers
0000-123049-P01-RST
19-012655
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy.


Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age.
  • Confirmed multiple gestation.

Eligibility last updated 10/18/21. Questions regarding updates should be directed to the study team contact.

 

Inflammatory bowel disease
Complication occurring during pregnancy, Digestive system, Inflammatory bowel disease, Reproductive system
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Evaluation of 7T Magnetic Resonance Imaging in Multiple Sclerosis

A Study to Evaluate 7T Magnetic Resonance Imaging in Multiple Sclerosis

Padraig Morris
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123051-H01-RST
19-012681
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Capable of giving consent.
  • Established diagnosis of Multiple Sclerosis according to McDonald Criteria (2018). Patients may be diagnosed with any of the conventional phases of MS, primary progressive, relapsing remitting, secondary progressive etc.
  • Willing to participate in a 7T MRI examination within a few days of their clinical 3T or 1.5T examination.


Exclusion Criteria:

  • Age < 18 years old.
  • Any metallic implant, device implant, ventriculoperitoneal shunt, cardiac valve, pacemaker which would constitute a contraindication to 7T imaging.
  • Previous craniotomy.
  • Permanent facial makeup (for brain scanning).
  • Suffer from claustrophobia.
  • Pregnancy.
  • Fever / elevated temperature.

 

 

 

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Assessing the psychosocial and financial impact of CAR-T on survivors and caregivers (APFCART)

Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

Urshila Durani
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123053-H01-RST
19-012702
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Inclusion Criteria:

  • Age ≥ 18.
  • Lymphoma diagnosis.
  • Receiving a CAR-T product.
  • Able to complete a written questionnaire in English either at home or with assistance at an appointment.
  • Able to perform a verbal interview either in person or via phone teleconference.


Exclusion Criteria:

  • Severe cognitive deficit of neuropsychiatric condition that would prevent person from being able to provide informed consent or complete survey or interview questions.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients (Spire)

A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

Roberto Benzo
All
40 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-123059-H01-RST
19-012772
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Inclusion Criteria:

  • Adults, age ≥ 40 years old.
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • At least 10 pack years of smoking.


Exclusion Criteria:
 

  • Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
  • Unable to follow commands (cognitive impairment).
  • Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
  • Live in an area that does not have cellular service (Verizon).

Eligibility last updated 8/27/21. Questions regarding updates should be directed to the study team contact.

Behavioral
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ROR1903: Spatially Fractionated Radiation (GRID) Therapy for Tumors of the Head and Neck, Thorax, Abdomen, and Extremities (GRID)

A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors

Daniel Ma
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123063-H01-RST
19-012801
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Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
  • Histological confirmation of oncologic diagnosis.
  • Completed oncologic imaging (per discretion of treating physician).
  • ECOG Performance Status 0-3.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Provide informed written consent.


Exclusion Criteria:
 

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.  NOTE:  Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Radiation, Radiotherapy to abdomen, Radiotherapy to head, Radiotherapy to neck, Radiotherapy to pelvis, Radiotherapy to thorax
Cancer, Head and neck cancer, Lung cancer, Stomach cancer
Cancer treatment, Digestive system, Fractionated radiation therapy, Medical Oncology, Neoplasm of abdomen, Neoplasm of extremity, Neoplasm of head and neck, Neoplasm of pelvis, Neoplasm of thorax, Radiation therapy, Reproductive system, Respiratory system
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Gathering Evidence to Determine Whether Modifications are Necessary to the Kansas City Cardiomyopathy Questionnaire (KCCQ) to Address Possible Interpretation Differences by Men and Women

A Study to Evaluate if Modifications to the Kansas City Cardiomyopathy Questionnaire Are Needed to Address Interpretation Differences by Gender

Shannon Dunlay
All
22 years and over
This study is NOT accepting healthy volunteers
0000-123064-H01-RST
19-012802
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Inclusion Criteria:

  • Age ≥ 22 years old.
  • A clinician-diagnosed NYHA I-IV heart failure.
  • LVEF ≤ 40% on most recent cardiac imaging.
  • Ability to read, speak and understand English.
  • Access to a telephone for interviews or ability to meet study staff in person for an interview.
  • Ability and willingness to participate in all study related activities.
  • Provide informed written or verbal consent based on site IRB requirements.


Exclusion Criteria:
 

  • Clinically significant cognitive or memory impairment in the opinion of research staff (e.g., patient has trouble holding a conversation, patient exhibits signs of disorientation).
  • Currently hospitalized.
  • Individuals who have left ventricular assist device (LVAD) or are planning to have surgery to implant an LVAD within 2 weeks of screening.
  • Individuals who have received a cardiac transplant at any time prior to screening.
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Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Jad Sfeir
All
55 years and over
This study is NOT accepting healthy volunteers
2020-101784-P01-RST
19-007740
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Inclusion Criteria:

  • Adults self-referred or referred by their physicians starting a senotherapeutic intervention.
  • Any individual with senescence-associated medical conditions as defined above, refractory to current standards or care, or without known treatments.
  • Any individual taking senotherapeutic agents or performing dietary restriction for any reason.


Exclusion Criteria:

  • Absolute contraindications to indicated senotherapeutic agents due to drug-drug or other interactions.
  • Pregnancy or breast-feeding.
  • Clinically significant dehydration, infection, renal or hepatic insufficiency.
  • Excessive acute or chronic alcohol use.
  • Acutely ill individuals requiring hospitalization, emergency, or urgent care.
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MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR (TIF vs LNF)

A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia

Barham Abu Dayyeh
All
22 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-300765-P01-RST
19-005226
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Inclusion Criteria:

  • 22
    •80 years of age.
  • Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
  • Pathologic reflux while off PPI based on Lyon criteria by either of the following:
    • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
    • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
  • Commitment to long-term study.
  • Ability to give consent individually or by a legally authorized representative.


Exclusion Criteria:

  • Hiatal hernia > 5 cm.
  • Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
  • Pregnancy (in females) at time of procedure.
  • Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
  • Subjects requiring mesh treatment at time of procedure.
  • Provider discretion.
  • BMI > 35.
Procedure/Surgery
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LS1981: Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL) or Histiocytic/Dendritic Cell Neoplasms

Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms

Jonas Paludo
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2020-300780-P01-RST
19-009349
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Inclusion Criteria
•Registration:

  • Age ≥ 18 years.
  • Non-Hodgkin lymphoma or histiocytic/dendritic cell neoplasm meeting one of the following criteria: 
    • Biopsy-proven relapsed and/or refractory Non-Hodgkin lymphoma . Relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted > 26 weeks. Refractory is no response (stable disease or progressive disease while on therapy) or relapse within 6 months. Refractoriness to autologous stem cell transplant will be defined as disease progression within 52 weeks following transplant.
    • Most recent tumor biopsy must be < 26 weeks prior to registration
    • Biopsy proven newly diagnosed histiocytic/dendritic cell neoplasm
    • Most recent tumor biopsy must be < 26 weeks prior to registration;
    • Biopsy-proven newly diagnosed histiocytic/dendritic cell neoplasms.
  • Measurable or assessable disease: Measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET/CT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥1.5 cm.
    • NOTE: Skin lesions can be used if the area is ≥ 1.5cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET/CT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic/dendritic cell neoplasms.
  • Patients with non-Hodgkin lymphoma must have previously been treated with at least 2 lines of therapy. This requirement does not apply to patients with histiocytic histiocytic/dendritic cell neoplasms.
  • ECOG Performance Status (PS) of 0, 1, or 2.
  • The following laboratory values obtained ≤ 21 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Hemoglobin ≥ 8.5 g/dL (may be transfused to reach criteria);
    • Total bilirubin < 2 x upper limit of normal (ULN) (or total bilirubin ≤ 3.0 x ULN with direct bilirubin ≤ 1.5 x ULN in patients with well-documented Gilbert’s Syndrome);
    • Aspartate transaminase (AST) ≤ 2.5 x ULN and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
    • Calculated creatinine clearance must be ≥ 35 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males = (140
      •age)(weight in kg)
    • ( 72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =  (140
      •age)(weight in kg)(0.85) ( 72)(serum creatinine in mg/dL).
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Female of childbearing potential (FCBP*) must commit to take highly effective contraceptive precautions** without interruption during the study and continue for at least 12 weeks after the last dose of selinexor and CS. FCBP must refrain from breastfeeding and donating oocytes during the course of the study.
  • Males must use an effective barrier method of contraception without interruption during the study and continue for at least 12 weeks after the last dose of selinexor and CS. They must refrain from donating sperm during the study participation.
  • * FCBP defined as sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (i.e., who have not menstruated at all) for at least 1 year.
  • ** Highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective forms of birth control include: hormonal contraceptives (oral, injectable, patch, and intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the patient.
    • NOTE: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willingness to provide mandatory blood specimens per protocol for PKs and banking, and mandatory tissue samples for correlative research.
    • NOTE: If an institution is not able to provide the tissue, it does not cause the patient to be ineligible; however, the collection of these tissues is strongly recommended.

Registration
•Exclusion Criteria

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women;
    • Nursing women.
  • Life expectancy of < 6 months.
  • Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.
  • Known intolerance to or contraindications for choline salicylate therapy. Patients with known allergy to ASA are not eligible.
  • Prior exposure to a SINE compound, including selinexor.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Active second malignancy requiring treatment that would interfere with the assessment of the response of the lymphoma to this protocol therapy. Patients with treated malignancies on hormonal therapy (for example breast or prostate cancer) are eligible.
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to registration.
    • NOTE: Exception: patients on any BTK inhibitor (ibrutinib, zanabrutinib, acalabrutinib, etc.), venetoclax, or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion. After the start of protocol therapy, corticosteroids can be used at  investigator’s discretion and tapered to lowest possible dose..
  • Active graft vs. host disease (after allogeneic stem cell transplantation) at registration.
  • Major surgery (including bowel resection) ≤ 3 weeks prior to registration.
  • Must not be currently eligible or have declined high-dose therapy with autologous stem cell transplantation rescue or CAR-T cell therapy.
  • Primary mediastinal (thymic) large B-cell lymphoma (PMBL).
  • Known active central nervous system (CNS) lymphoma. Patients with previous CNS involvement can enroll if the CNS component is inactive.
  • Patients who are on active anticoagulant therapy with direct oral anticoagulants (DOACs), aspirin or warfarin are not eligible due to potential bleeding. 
    • EXCEPTIONS: Patients who are on aspirin (81 mg) for primary prevention of cardiovascular disease can enroll, but the ASA needs to be held while on this protocol therapy. 
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Patients known to have active hepatitis B, or C infection, or known to be positive for HCV RNA or HBsAg (HBV surface antigen). Patients known to be HIV positive, except those with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL and on an established ART for at least twelve weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.

 

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CureGN: Cure Glomerulonephropathy Network

A Registry and Biospecimen Collection to Advance the Diagnosis and Care of Patients with Glomerular Diseases

Fernando Fervenza
All
Not specified
This study is NOT accepting healthy volunteers
2020-300830-P01-RST
19-012484
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Inclusion Criteria

  • Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
  • First diagnostic kidney biopsy within 5 years of study enrollment.
  • Access to first kidney biopsy report and/or slides.
  • All ages.
  • Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
  • Informed consent and, where age appropriate, informed assent.

 Exclusion Criteria

  • ESKD, defined as chronic dialysis or kidney transplant.
  • Institutionalized.
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
  • Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
    • Diabetes mellitus;
    • Histopathologic findings of diabetic glomerulosclerosis;
    • Systemic lupus erythematosus;
    • HIV infection;
    • Active malignancy, except for non-melanoma skin cancer;
    • Active Hepatitis B or C infection, defined as positive viral load.
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A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ

A Study to Evaluate Oral Tamoxifen vs. TamGel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ

Amy Degnim
Female
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2020-300972-P01-RST
19-011444
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Inclusion Criteria:

  • Willing to return to enrolling institution for follow-up.
  • Willing to complete required testing. 
  • Ability to complete questionnaire by themselves or with assistance.
  • Female (sex that was assigned at birth).
  • Ipsilateral intact breast with histology confirmation of atypical ductal or lobular  hyperplasia, or LCIS, within the last 12 months, whether surgically excised or not.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Willingness to agree to use ONE effective form of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for 2 months following the last dose of study medications. Effective birth control methods are:
    • copper IUD [intrauterine device];
    • diaphragm/cervical cap/shield;
    • spermicide;
    • contraceptive sponge;
    • condoms.
  • Women of childbearing potential must have a  negative pregnancy test within five days before starting study medications. Should a  participant become pregnant or suspect she is pregnant while participating in this study; the participant should inform the study physician immediately.
  • Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e., tanning beds) for the duration of the study.
  • Participants must have acceptable organ and marrow function as defined below within 30 days of randomization: judged by treating physician's evaluation of baseline laboratory data.
  • Negative urine pregnancy test, if of childbearing potential and / or FSH to verify menopausal status.  


Exclusion Criteria:

  • Clinically suspicious mass/lesions.
  • Breast cancer in the past 5 years.
  • Prior thromboembolism within last 5 years (history of varicose veins and superficial phlebitis is allowed).
  • Current pregnancy or lactation.
  • History of other prior breast cancer-specific therapy within the previous 2 years (chemotherapy, anti-HER2 agents,  endocrine agents, everolimus, CDK4-6 inhibitors).
  • Cytotoxic chemotherapy for any indication in last 2 years.
  • Prior use of SERMS or AIs including tamoxifen, raloxifene, anastrozole, letrozole, or exemestane for prevention or therapy within 5 years.
  • Exogenous sex steroid, including oral contraceptive pill use within 1 month prior to  research core needle biopsy (CNB).
  • Use of vaginally administered estrogens and hormone coated IUD such as Mirena is permitted.
  • History of any prior ipsilateral breast radiotherapy. Previous unilateral radiation of the contralateral side is allowed.
  • Skin lesions on the breast that disrupt the stratum corneum (e.g., eczema, ulceration).
  • History of endometrial neoplasia.
  • Current smoker. Cessation for at least 6 weeks.
  • Current users of potent inhibitors of tamoxifen metabolism. The potent inhibitors of tamoxifen metabolism are: bupropion, cinacalcet, fluoxetine, paroxetine, quinidine.
  • Participants may not be receiving any other investigational agents within 90 days of enrollment or during this study.
  • History of allergic reactions to tamoxifen.
  • Uncontrolled intercurrent illness that in the judgement of the treating physician  would make them unsuitable for study participation.
  • Anticoagulation meds and clinical concern for discontinuing meds for study research biopsy.  
  • Identification of a clinically suspicious mass on examination.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

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Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation

A Study to Evaluate Therapeutic and Side Effects of Brain Stimulation

Brian Lundstrom
All
1 years to 99 years old
This study is NOT accepting healthy volunteers
2020-302381-H01-RST
19-002063
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Key Inclusion Criteria:

  • Patients that receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes and brain tumors.

Key Exclusion Criteria

  • Patients that do not receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes, and brain tumors.

     

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2)

A Study to Assess the Effectiveness and Safety of Durvalumab Alone or Combined with Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

Sean Cleary
All
18 years to 150 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101020-P01-RST
19-005862
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Inclusion Criteria:
 

  • Male and female.
  • Provision of signed and dated written informed consent form (ICF) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, EU Data Privacy Directive in the EU) obtained from the patient (or legal representative / impartial witness where mandated & allowed by local regulations) prior to any mandatory study-specific procedures, sampling, and analyses, including screening evaluations.
  • Age ≥ 18 years at the time of screening. For patients aged < 20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative. Patients aged < 21 years must not be enrolled in Egypt or Singapore.
  • Histologically or cytologically (or radiologically for patients undergoing curative ablation) confirmed HCC, newly diagnosed, and successfully completed curative therapy (resection or ablation). (a) Hepatic resection and have the following pathologic and/or radiologic findings from surgery: (i) Any size with microvascular invasion (clear pathologic assessment on microvascular invasion: Yes or No) and/or satellite tumor (ii) 3 or less tumors, with at least one > 5 cm (iii) 4 or more tumors, ≤ 5 cm each (b) Ablation (radiofrequency or microwave, cryoablation, or PEI per institutional standard. Embolisation (e.g., TACE/TAE) is acceptable so long as it is part of the local planned ablative process) where all curative procedures are completed within a 12 week window, and have the following radiologic findings prior to ablation: (i) Solitary tumor, 3 to 5 cm (ii) 2 to 4 tumors, ≤ 5 cm each (iii) Exclude patients with 5 or more tumors.
  • Patients must be randomized within 12 weeks of completion of curative hepatic resection, or final curative ablation procedure.
  • Imaging to confirm disease-free status within 28 days prior to randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 at enrollment.
  • Child-Pugh score of 5 or 6. 8 Patients with active HBV infection (as characterized by positive hepatitis B virus surface antigen [HBsAg] and/or anti-hepatitis B core antibodies (HBcAbs) with detectable HBV deoxyribonucleic acid (DNA) [≥10 IU/mL or above the limit of detection per local laboratory]) must receive antiviral therapy at least after enrollment (sign of ICF) per institutional practice. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Patients must show evidence of HBV stabilization or signs of viral response (e.g., reduction HBV DNA levels) prior to randomization. Patients who test positive for anti-HBcAb with undetectable HBV DNA (< 10 IU/mL or under the limit of detection per local laboratory) do not require antiviral therapy. These patients will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU/mL or above the limit of detection per local laboratory). Patients with detectable HBV DNA during the study must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment.
  • Patients with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid (RNA)) must be managed per local institutional practice for the study duration.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. A definition of post-menopausal.
  • Adequate organ and marrow function, as defined below. Criteria “a,” “b,” “c,” and “f” cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose:
    • Hemoglobin ≥ 9 g/dL;
    •  Absolute neutrophil count ≥ 1000/µL;
    • Platelet count ≥ 65000/µL;
    • Total bilirubin (TBL) ≤ 2.0 × upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) and ALT ≤ 5 × ULN;
    •  Albumin ≥ 2.8 g/dL;
    • International normalized ratio ≤ 1.6 (for patients receiving Warfarin, please consult with the study physician);
    • Urine protein 2+ or less;
    • Tested blood urea nitrogen or creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CL) ≥ 51 mL/min as determined by the Cockcroft-Gault formula (using actual WT) or 24-hour urine creatinine CL;
    • Males: Creatinine CL (mL/min)=WT (kg) × (140
      •Age) 72 × serum creatinine (mg/dL); Females:  Creatinine CL (mL/min) = WT (kg) × (140
      •Age) × 0.85 72 × serum creatinine (mg/dL).


Exclusion Criteria:
 

  • History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to randomization.
  • History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 3 months prior to study randomization.
  • History of GI perforation and/or fistulae within 6 months prior to randomization.
  • Any history of nephrotic or nephritic syndrome.
  • Evidence of symptomatic congestive heart failure (New York Heart Association II to IV) or symptomatic or poorly controlled cardiac arrhythmia.
  • History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
  • Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg despite standard medical management.
  • Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging undertaken at the screening visit, or within 6 months (24 weeks) of randomization.
  • Evidence of distant metastasis (except regional lymph node metastases related to the disease under study, per Appendix F), co-existing malignant disease or macrovascular invasion on baseline imaging.
  • History of hepatic encephalopathy within 12 months prior to randomization or requirement for medications to prevent or control encephalopathy (no lactulose, rifaximin, etc, if used for purposes of hepatic encephalopathy).
  • Evidence of portal vein thrombosis, visible on baseline/eligibility imaging, and patients with Vp1, Vp2, Vp3 and Vp4 (benign portal vein thrombosis is allowed, where not related to tumor thrombus, and anti-thrombotics may be used as needed).
  • Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control, within 6 months prior to the first dose of study treatment. (a) Patients with ascites who have required pharmacologic intervention (e.g., diuretics) and who have been on stable doses of diuretics for ascites for ≥ 2 months before randomization are eligible.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except for diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, and uveitis]). The following are exceptions to this criterion:
    • Patients with vitiligo or alopecia;
    • Patients with hypothyroidism (e.g., following Hashimoto syndrome), stable on hormone replacement;
    • Any chronic skin condition that does not require systemic therapy;
    • Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician;
    • Patients with celiac disease controlled by diet alone.
    • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs or compromise the ability of the patient to give written informed consent.
    • History of another primary malignancy except for the following:
      • Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a prior prostatectomy without biochemical recurrence and who, in the opinion of the Investigator, are not deemed to require active intervention, or patients with incidental histologic findings of prostate cancer that has not been treated prior to the study and who do not require specific therapy for prostate cancer beyond the surgery described in the Clinical Study Protocol and also are considered to be at low risk for recurrence per the Investigator;
      • Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment and of low potential risk for recurrence;
      • Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease;
      • Adequately treated carcinoma in situ without evidence of disease;
      • Patients with another primary malignancy that is not active or expected to be clinically relevant in the next 5 years may be considered further to discussion with the Study Physician.
  • Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) or human immunodeficiency virus (HIV; positive for HIV 1/2 antibodies).
  • Active co-infection with both HBV and hepatitis D virus.
  • Known allergy or hypersensitivity to any of the study treatments or any of the study treatment excipients.
  • History of aneurysm (Patients with a capped aneurysm may be included but only after consultation with the Study Physician).
  • Major surgery (as defined by the Investigator) within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization (biopsy from any type of surgery within 28 days is not an exclusion criteria, nor are procedures to treat varices).
  • Receipt of routine treatment for chronic condition with nonsteroidal anti-inflammatory agents (e.g., indomethacin, ibuprofen, naproxen, or similar agents) or other anti-platelet agents (e.g., clopidogrel, ticlopidine, dipyridamole, or anagrelide). Require minimum washout period of 5 days prior to randomization. Low dose aspirin (≤ 325 mg/day) is permitted. Prohibited concomitant medications with exceptions.
  • Receipt of prior systemic anticancer therapy for HCC.
  • History of allogeneic organ transplantation or those who are on a waiting list for liver transplantation.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
    • Note: Patients, if enrolled, should not receive live vaccine while receiving study treatment and up to 90 days after the last dose of study treatment.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. The following are exceptions to this criterion:
    • Intranasal, inhalational, topical steroids, or local steroid injections (e.g., intra-articular injection);
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;
    • Steroids as pre-medication for hypersensitivity reactions (e.g., CT-scan premedication).
  • Receipt of treatment with herbal medications labelled for the treatment of HCC (e.g., Huaier) within 14 days prior to first dose of study treatment.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient’s preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Involvement in the planning and/or conduct of the study for both AstraZeneca staff and/or staff at the study site.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Destruction of lesion of liver, Destructive procedure, Drug therapy, Immunotherapy for cancer, Removal of liver lesion
Cancer, Hepatocellular carcinoma, Liver cancer, Liver tumor
Ablation, At risk of malignancy, Bevacizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Durvalumab [USAN:INN], Liver cell carcinoma, Liver tumor ablation, Medical Oncology, bevacizumab, durvalumab
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Mayo Clinic — Rochester, MN

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy) (AALL1731)

A Study to Determine the Outcomes of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy

Mira Kohorst
All
365 days to 31 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101280-P01-RST
19-009277
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Inclusion Criteria:


- All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening
(Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement
for B-LLy patients. B-LLy patients may directly enroll on AALL1731.

- Age at diagnosis:

- Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).

- Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).

- Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or
without DS).

- B-ALL patients without DS must have an initial white blood cell count < 50,000/uL
(performed within 7 days prior to enrollment).

- B-ALL patients with DS are eligible regardless of the presenting white blood cell
count (WBC) (performed within 7 days prior to enrollment).

- Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on
a bone marrow (BM) aspirate;

- OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis
can be established by a pathologic diagnosis of B-ALL on a BM biopsy;

- OR a complete blood count (CBC) documenting the presence of at least 1,000/uL
circulating leukemic cells;

- OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without
Down syndrome.

- Note: For B-LLy patients with tissue available for flow cytometry, the criterion
for diagnosis should be analogous to B-ALL. For tissue processed by other means
(i.e., paraffin blocks), the methodology and criteria for immunophenotypic
analysis to establish the diagnosis of B-LLy defined by the submitting
institution will be accepted (diagnostic biopsy for B-LLy must be performed
within 14 days prior to enrollment).

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.

- All patients and/or their parents or legal guardians must sign a written informed
consent.


Exclusion Criteria:


- Patient must not have secondary ALL that developed after treatment of a prior
malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior
history of transient myeloproliferative disease (TMD) are not considered to have had a
prior malignancy. They would therefore be eligible whether or not the TMD was treated
with cytarabine.

- With the exception of steroid pretreatment or the administration of intrathecal
cytarabine, patients must not have received any prior cytotoxic chemotherapy for
either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to
initiation of protocol therapy on AALL1731.

- For patients receiving steroid pretreatment, the following additional exclusion
criteria apply:

- Non-DS B-ALL patients must not have received steroids for more than 24 hours in
the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to
initiation of the steroids.

- DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV
steroids within 4 weeks of diagnosis.

- Patients who have received > 72 hours of hydroxyurea within 1 week (7 days) prior to
the start of systemic protocol therapy.

- B-ALL patients who do not have sufficient diagnostic bone marrow submitted for
APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted
containing > 1,000/uL circulating leukemia cells.

- Patient must not have acute undifferentiated leukemia (AUL).

- Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be
known prior to enrollment).

- Note: DS patients with CNS3 disease are eligible but will be assigned to the
DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior
to administration of any systemic or intrathecal chemotherapy, except for steroid
pretreatment.

- Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular
disease are eligible but will be assigned to the DS-High B-ALL arm).

- For LLy patients, the following additional exclusion criteria apply:

- T-Lymphoblastic Lymphoma.

- Morphologically unclassifiable lymphoma.

- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma.

- CNS positive disease or testicular involvement.

- M2 (5%
•25% blasts) or M3 (> 25% blasts) marrow.

- Patients with known Charcot-Marie-Tooth disease.

- Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,
regardless of blast immunophenotype.

- Patients requiring radiation at diagnosis.

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential.

- Lactating females who plan to breastfeed their infants.

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Acute lymphocytic leukemia, Cancer, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
B-cell acute lymphoblastic leukemia, Biological therapy for cancer, Cancer treatment, Chemotherapy, Hematopoietic system, Medical Oncology
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Development of Technologies to Increase In-Seat Movement to Prevent Sitting Acquired Pressure Injuries in Wheelchair Users: AIM 3 Evaluation

Technologies to Increase In-Seat Movement to Prevent Sitting Acquired Pressure Injuries in Wheelchair Users

Susan Hallbeck
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122605-H01-RST
19-008916
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Inclusion Criteria:


- 18 years of age or older

- Be able to come to Mayo Clinic, UMN, or Georgia Tech campuses for study visits OR
participate in virtual video study visits

- Use a wheelchair for their primary form of mobility

- Use a skin protection and positioning wheelchair cushion

- Be able to perform weight shifts independently without assistance of another person (by moving themselves or using of power tilt)

- Own and are able to operate a smartphone with Apple or Android operating system

- Are willing to download and use the mobile apps on their phone


Exclusion Criteria:


- Are scheduled for flap surgery

- There is an active stage 3, 4, or unstageable pressure injury as defined by the National Pressure Injury Advisory Panel definitions anywhere on their sitting surface at time of enrollment

- Use of a custom molded wheelchair cushion or alternating air cushion

- Have/use the recline function on their power wheelchair

- Have/use the standing function on manual or power wheelchair

- Have a prescribed or limited sitting time of less than 5 hours per day

- Live in a long-term care facility or group home and require 24 hours/day assistance

- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Behavioral, Other
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Mayo Clinic — Rochester, MN