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
- 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
- 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
Advanced Heart Failure Epidemiology and Outcomes Part 2: Burden of Treatment and Illness
A Study to Evaluate the Burden of Treatment and Illness in Advanced Heart Failure Patients
- Advanced heart failure.
- Southeastern Minnesota resident
- None.
ALSENLITE: An Open-label Pilot Study of Senolytics for Alzheimer's Disease (ALSENLITE)
ALSENLITE: Senolytics for Alzheimer's Disease
1. Men and women of age 55 years and older at the time of enrollment
2. Clinical diagnosis of symptomatic probable AD (MMSE 26 to 15 or Short Test of Mental
Status 31 to 15 inclusive and/or Clinical Dementia Rating Scale/CDR = 0.5 to 2,
inclusive)
3. Not on cholinesterase inhibitors or memantine; or if on cholinesterase inhibitors
and/or memantine, on a stable dose for at least three months
4. Body Mass Index (BMI) within range of 19
•50 kg/ m2
5. Participants must be accompanied by a LAR designated to sign informed consent and to
provide study partner reported outcomes at all visits
6. Participants must have no plans to travel over the ~3 months between Visits 3 and 14
that interfere with study visits
7. Tau positivity by brain PET imaging
8. Adequate blood counts i.e. platelets > 50,000 per microliter; HB > 9/dL, and ANC >
1000 per microliter
9. Availability and consent from a LAR.
1. Unwilling or unable to give informed consent
2. Pregnancy
3. QTc > 450 msec on baseline ECG
4. MRI contraindications
5. Presence of uncontrolled psychiatric disorder (as per clinical judgment)
6. Presence of uncontrolled systemic lupus erythematosus (as per clinical judgment)
7. Substance or alcohol abuse (current alcohol use > 3 alcoholic beverage/day or > 21 per
week and as per clinical judgment)
8. Hearing, vision, or motor deficits despite corrective devices (as per clinical
judgment)
9. Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6
months
10. Chronic heart failure (as per clinical judgment)
11. Neurologic, musculoskeletal, or other condition that limits subject's ability to
complete study physical assessments (as per clinical judgment)
12. Positive SARS-CoV-2 test within 30 days prior to enrollment
13. AST/ALT > 2.5x upper limit normal
14. Presence of significant liver disease with total bilirubin > 2X upper limit or as per
clinical judgment
15. Inability to tolerate oral medication (as per clinical judgment)
16. Abnormality in any of the screening laboratory studies (see section 6.21.2) or as per
clinical judgment
17. Malabsorption (as per clinical judgment)
18. Known human immunodeficiency virus infection (as per clinical judgment)
19. Known active hepatitis B or C infection
20. Invasive fungal or viral infection (as per clinical judgment)
21. Known hypersensitivity or allergy to D or Q
22. Uncontrolled pleural/pericardial effusions or ascites (as per clinical judgment)
23. New/active invasive cancer except non-melanoma skin cancers
24. Inability to tolerate oral medications (as per clinical judgment)
25. Currently taking AND unable to safely hold any of the medications listed in Appendix 1
during the days IP is administered and for 36 hours after IP administration.
26. Uncontrolled diabetes (defined as HbA1c > 7% or as per clinical judgment).
27. Gastric bypass/reduction
28. Crohn's disease
29. Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase
or ESR) (as per clinical judgment)
30. eGFR < 10 ml/ min/ 1.73 m2
31. Creatinine clearance < 60 mL/min/1.73 m2
32. Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low
molecular weight heparin, factor Xa inhibitors, etc.)
33. On antiplatelet agents (e.g., full dose Aspirin, Clopidogrel etc.). Baby aspirin (81
mg), if absolutely necessary from cardiac perspective, will be allowed
34. Presence of any condition that the Investigator believes would put the subject at risk
or would preclude the patient from successfully completing all aspects of the trial
Involvement of special vulnerable populations: We will not involve special vulnerable
populations, such as fetuses, neonates, pregnant women, children, prisoners,
institutionalized individuals, or others who may be considered vulnerable populations
except for patients with dementia. Therefore, availability and consent from a LAR is an
inclusion criterion.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.
Pilot Study of Circulating Cell Free Tumor DNA as a Biomarker in Sarcoma
A Study to Evaluate Circulating Cell Free Tumor DNA as a Biomarker in Sarcoma
Inclusion Criteria:
- Age 18 years old and older.
- Advanced or metastatic bone or soft tissue sarcoma with a known translocation.
- Evidence of disease progression or recurrence prior to initiation of systemic therapy.
- No systemic therapy or major surgery within the past 30 days.
- Willingness to provide blood and urine samples.
- The absence of a second active malignancy.
- An understanding of the protocol and its requirements, risks and discomforts.
- Ability and willingness to sign an informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to understand the informed consent.
Study to Evaluate the Effects of BKR-017 on Insulin Sensitivity and Triglycerides in Type 1 Diabetes Subjects
Butyrate Adjuvant Therapy for Type 1 Diabetes
1. All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and
<80 years of age recruited from the Mayo Clinic Endocrinology Clinic;
2. Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4.
1. Except for the use of insulin, no other treatments for T1D will be permitted.
2. Pregnancy
3. Inability or unwillingness of individual or legal guardian/representative to give
written informed consent.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 2/8/23. Questions regarding updates should be directed to the study team contact.
Insomnia in patients with metastatic non small cell lung cancer.
Metastatic Non-Small Cell Lung Cancer Insomnia
- Have a diagnosis of metastatic non small cell lung cancer.
- Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy.
- Subjects will be limited to older than 18 years old at the time of diagnosis.
- Have advanced terminal cancer, severe depression, or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing).
- Regular use of psychotropic medication other than hypnotics (e.g., antidepressants) per chart review.
Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.
A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache
A Study to Investigate Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache
- Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as
defined by the International Classification of Headache Disorders (ICHD-3).
- PTH onset 7-28 days prior to the time of enrollment
- Adults 18-70 years of age
- Willing to be randomized to either of the two clinical trial treatment arms
- Willing to maintain a headache diary
- Willing and able to return for follow-up visits
- 5 or more moderate or severe headache days during the 4-week run-in phase
- At least 80% compliant with diary keeping during the 4-week run-in phase (i.e.,
provides data on at least 80% of days)
- Episodic tension-type headache, migraine, or other headaches with at least 4 headache
days/month on average over the 6 months prior to the mTBI resulting in PTH
- Previous history of chronic headache (i.e., at least 15 headache days/month) including
PPTH, chronic migraine, medication overuse headache, new daily persistent headache,
hemicrania continua, chronic tension-type headache
- Diminished decision-making capacity that in the investigator's opinion would interfere
with the person's ability to provide informed consent and complete study procedures
- Current or prior use of preventive medications for migraine or other primary headache
disorder
- Use of onabotulinumtoxinA in the head, neck or face region within 12 months of
screening
- During the 6 months before screening, use of opioids or barbiturates on an average of
at least 4 days per month
- Subjects who underwent an intervention or used a device (e.g., nerve blocks,
transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal
nerve stimulation) for headache
- History of major psychiatric disorder such as schizophrenia and bipolar disorder
- History or evidence of any unstable or clinically significant medical condition, that
in the opinion of the investigator, would pose a risk to subject safety or interfere
with the study evaluation, procedures, or completion
- History of positive neuroimaging findings that indicate a moderate or severe TBI
- Contraindications to magnetic resonance imaging, including, but not limited to (only
an exclusion for patients participating in the brain MRI portion of this research):
1. Metal implants
2. Aneurysm clips
3. Severe claustrophobia
4. Implanted electronic device
5. Insulin or infusion pump
6. Cochlear/otologic/ear implant
7. Non-removable prosthesis
8. Implanted shunts/catheters
9. Certain intrauterine devices
10. Tattooed makeup
11. Body piercings that cannot be removed
12. Metal fragments
13. Wire sutures or metal staples
- Factors that reduce MR image quality and interpretability (only an exclusion for
patients participating in the brain MRI portion of this research):
1. Dental braces or other non-removable devices (e.g., retainers)
2. Prior brain surgery
3. Known brain MRI abnormality that in the investigator's opinion will significantly
impact MRI data
- Sensory disorders that in the investigator's opinion might affect perception of
cutaneous thermal stimuli (e.g., peripheral neuropathy) (only an exclusion for
patients participating in the neurophysiology studies)
- Pregnancy
- Breastfeeding
- History of myocardial infarction, stroke, transient ischemic attack, unstable angina,
coronary artery bypass surgery, or other revascularization procedures within 12 months
prior to screening.
- Not willing to use a reliable form of contraception (for women of childbearing
potential) through 16 weeks after the last dose of erenumab. Acceptable methods of
birth control include not having intercourse, hormonal birth control methods,
intrauterine devices, surgical contraceptive methods, or two barrier methods (each
partner must use a barrier method) with spermicide. A reliable form of contraception
must be started prior to or at the time of starting the run-in phase. Not being of
childbearing potential is defined as any woman who is post-menopausal by history,
defined as:
1. At least 55 years of age with cessation of menses for 12 or more months; OR
2. Younger than 55 years of age but no spontaneous menses for at least 2 years; OR
3. Younger than 55 years of age and spontaneous menses within the past 1 year, but
currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with
postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating
hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5
ng/dL) or according to the definition of "postmenopausal range" for the
laboratory involved; OR
4. Underwent bilateral oophorectomy; OR
5. Underwent hysterectomy; OR
6. Underwent bilateral salpingectomy.
- Currently or within 90 days prior to screening: received treatment in another drug
study or an investigational device study
- Has previously received any CGRP ligand or receptor targeted monoclonal antibody
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/25/22. Questions regarding updates should be directed to the study team contact.
A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Key
Ovarian Cancer Cohorts Only:
- Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
- serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening);
- has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts);
- documented relapse or progression on or after the most recent line of therapy;
- no standard therapy options likely to convey clinical benefit.
2. Adequate organ and bone marrow function as defined in the protocol.
3. Life expectancy of at least 3 months.
4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the
protocol.
Endometrial Cancer Cohorts Only:
- histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
- MUC16 positivity of tumor cells ≥ 25% by immunohistochemistry (IHC);
- 1-2 prior lines of systemic therapy.
Key
- Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol.
- Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy.
- Prior treatment with a MUC16
•targeted therapy. - Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol.
- History and/or current cardiac findings as defined in the protocol.
- Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen.
Note: Other protocol Inclusion/Exclusion Criteria apply.
Eligibility last updated 1/2/24. Questions regarding updates should be directed to the study team contact.
A Qualitative Study of the Use of Cold Caps to Prevent Hair Loss During Chemotherapy
A Study of the Use of Cold Caps to Prevent Hair Loss in Chemotherapy Patients
- Patients who have used a cold cap at least once for purposes of hair loss prevention during chemotherapy treatment.
- None.
Long Term Evaluation of Thymoma Recurrence
A Study to Evaluate Thymoma Recurrence
- ≥ 18 years old.
- Previous thymectomy at Mayo Clinic.
-
Pathology other than thymoma or thymic carcinoma.
Intercept Somatic (Intercept Somatic)
Intercept Somatic
RETROSPECTIVE STUDY
•NO PARTICIPANT CONTACT
Patient Experience and Understanding of Genetic Testing in Ovarian Cancer
Patient Experience and Understanding of Genetic Testing in Ovarian Cancer
- Initial diagnosis of ovarian cancer.
- Patients undergoing primary debulking surgery followed by adjuvant chemotherapy.
- Non-English speaking.