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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

602 Study Matches

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Quantitative Magnetization Transfer MRI for Evaluation of Renal Fibrosis

Quantitative Magnetization Transfer MRI for Evaluation of Renal Fibrosis

Lilach Lerman
All
40 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122550-H01-RST
19-008413
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Inclusion Criteria:


- Between ages 40 and 80 years old.

- Patients with hypertension (BP>140/90 mmHg) and/or requirement for two or more
antihypertensive medications for more than 4 weeks.

- Serum creatinine under 2.2 and 2.0 mg/dL for men and women, respectively (Caucasians).
Values for African-American subjects are slightly higher (2.4 mg/dL, males; 2.1 mg/dL
females).

- No contraindications to angiography: severe contrast allergy.

- No contraindications to no-contrast MR evaluations: e.g. pacemaker or magnetically
active metal fragments, claustrophobia.

- Patients have the ability to comply with protocol

- Patients are competent and able to provide written informed consent


Exclusion Criteria:


- Patient has serum creatinine >2.2 mg/dL for men and >2.0 mg/dL for women (Caucasians);
>2.4 mg/dL for men and >2.1 mg/dL for women (African American).

- RVD in a solitary kidney

- Patients have clinically significant medical conditions within the prior six months:
e.g. myocardial infarction, congestive heart failure, stroke, that would, in the
opinion of the investigators, compromise the safety of the patient.

- Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy).

- Diabetes requiring insulin or oral hypoglycemic medications.

- Evidence of hepatitis B or C, or HIV infection.

- Requirement for potentially nephrotoxic drugs; e.g., non-steroidal anti-inflammatory
drugs.

- Cardiac ejection fraction less than 30%.

- History of deep venous thrombosis within 3 months of enrollment.

- Kidney transplant.

- Pacemaker, implantable defibrillator or other contraindication to MRI

- Inability to comply with breath-hold for 20 seconds

- Any active malignancy and undergoing therapy

- Patients are pregnant.

- Kidney or ureteric stone

- Another known acute or chronic kidney disease

- Federal medical center inmates.

- Latex allergy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact

Other
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Mayo Clinic — Rochester, MN

Radiation and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita/Telomere Disease

A Study to Evaluate Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients with Dyskeratosis Congenita

William Hogan
All
up to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122554-P01-RST
19-008461
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Inclusion Criteria:

  • Bone marrow hypocellular for age.
  • Moderate or severe aplastic anemia defined by one of the following: peripheral blood neutrophils < 0.5 x 10^9/L; platelets < 30 x 10^9/L or platelet transfusion dependence; reticulocytes < 50 x 10^9/L in anemic patients or red cell transfusion dependence.
  • Diagnosis of dyskeratosis congenita based on clinical triad of abnormalities of skin pigmentation, nail dystrophy, oral leukoplakia; OR one of clinical triad and presence of two or more associated features; OR a pathogenic mutation in DKC1,TERC, TERT, NOP10, NHP2, TCAB1, TINF2, CTC1, PARN, RTEL1, or ACD as reported by a CLIA-approved laboratory; OR age-adjusted mean telomere length < 1%ile in peripheral blood lymphocytes as reported by a CLIA-approved laboratory; OR Hoyeraal-Hreidarsson syndrome; OR Revesz syndrome
  • Availability of a related or unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1.
  • Patient and/or legal guardian must be able to sign informed consent.
  • Donor must provide a marrow allograft.
  • Diagnosis of Fanconi anemia must be excluded by mitomycin C or diepoxybutane chromosomal breakage testing on peripheral blood at a CLIA-approved laboratory (not required for patients with a genetic mutation consistent with DC).
  • Adequate renal function with glomerular filtration rate equal to or greater than 30 ml/min/1.73 m2.


Exclusion Criteria:

  • Clonal cytogenetic abnormalities associated with MDS or AML on bone marrow examination.
  • Karnofsky/Lansky performance status < 40.
  • Uncontrolled bacterial, viral or fungal infections.
  • Positive test for the human immunodeficiency virus (HIV).
  • Pregnancy or breastfeeding.
  • Known severe or life-threatening allergy or intolerance to fludarabine, alemtuzumab, cyclosporine, or mycophenolate mofetil.
  • Positive patient anti-donor HLA antibody, which is deemed clinically significant.
  • Prior allogeneic marrow or stem cell transplantation.
  • Prior solid organ transplantation.
Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

Stories for Change: Digital Storytelling for Diabetes Self-Management Among Somali Adults (S4C)

Stories for Change: Digital Storytelling for Diabetes Self-Management Among Somali Adults

Jane Njeru
All
18 years to 75 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122564-H01-RST
19-008588
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Inclusion Criteria:

  • Self-identifies as Somali.
  • Between 18 and 75 years of age.
  • Receives primary care at Mayo Clinic ECH.
  • Visited the primary care site at least once in the least twelve months.
  • Intention to continue receiving care at the clinic for the next six months.
  • Diagnosis of T2D in medical record.
  • T2D diagnosis for six months or longer.
  • Most recent hemoglobin A1c ≥ 8%.


Exclusion Criteria:

  • Not eligible if someone in the same household is participating in the study.
Behavioral, Assessment of readiness for self-management, Diabetic care management, Education about self management of diabetes, Promotion of self management of symptom, Provision of support for self-management, Support for self-management
Diabetes, Type 2 diabetes
Endocrine system, Type 2 diabetes mellitus
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Mayo Clinic — Rochester, MN

Utility of Advanced Ultrasound Techniques for Diagnosis of Giant Cell Arteritis

A Study to Evaluate Advanced Ultrasound Techniques for Diagnosis of Giant Cell Arteritis

Lilly Wagner
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122583-H01-RST
19-008794
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Inclusion Criteria:

  • Adult male and non-pregnant women 18 years old or older.
  • Subject has suspected temporal arteritis.
  • Subject is scheduled for TAB based on clinical diagnostic protocol.
  • Subject is able to understand the study procedure and provide informed consent.


Exclusion Criteria:

  • Subject has an established prior diagnosis of temporal arteritis/giant cell arteritis.
  • Subject is pregnant or breast feeding.
  • Subject is unable to provide informed consent.
Giant cell arteritis, Vasculitis
Circulatory system, Temporal arteritis, Ultrasound
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Mayo Clinic — Rochester, MN

Wellness Coaching for Caregivers of Thoracic Transplant Candidates

A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Cassie Kennedy
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122584-H01-RST
19-008807
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Inclusion Criteria:
 

  • Aged 18 or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester, MN and Jacksonville, FL.


Exclusion Criteria:
 

  • Individuals younger than 18.
  • Those who are non-English speaking, non-verbal, or extremely hard of hearing.
Pre-surgery evaluation, Behavioral, Caregiver support, Heart-lung transplant with recipient cardiectomy-pneumonectomy, Providing reassurance to caregiver, Transplant of lung, Transplantation of heart, Wellness promotion
Anxiety disorder, Depression
At risk for caregiver role strain, Caregiver of a person with chronic disease, Caregiver role strain, Heart transplant, Lung transplant, Seen by health coach, Awaiting transplantation of heart, Awaiting transplantation of lung, Integrative medicine, Resilience training, Stress management, Transplanted heart present, Transplanted lung present, Wellness coaching
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Mayo Clinic — Rochester, MN

Exercise and Hypoxic Responses to Isovolemic Hemodilution in Rare Hemoglobin Variant Humans

A Study to Evaluate Exercise and Hypoxic Responses to Isovolemic Hemodilution in Rare Hemoglobin Variant Humans

Michael Joyner
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122648-H01-RST
19-009290
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Inclusion Criteria:

  • Healthy adult (> 18) men and women of all races and ethnic backgrounds.
  • Recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities. 


Exclusion Criteria:

  • Children under the age of 18 years old.
Other
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Mayo Clinic — Rochester, MN

Manipulation Under Anesthesia After Bilateral Primary Total Knee Arthroplasty; Characterization of Genetic Profile

A Study to Evaluate Manipulation Under Anesthesia After Bilateral Primary Total Knee Arthroplasty

Matthew Abdel
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122655-H01-RST
19-009366
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Inclusion Criteria:

  • Age > 18 years old.
  • Primary total knee performed, 2000-2019.
  • Development of knee stiffness requiring manipulation under anesthesia.
  • Primary surgery and manipulation performed at Mayo Clinic Rochester, MN.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Pregnant women.

 

 

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Mayo Clinic — Rochester, MN

Whole Genome Sequencing of a Patient with Early Onset Osteoarthritis

A Study to Evaluate Early Onset Osteoarthritis

Christopher Evans
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122663-H01-RST
19-009386
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Inclusion Criteria:

  • Early-onset osteoarthritis diagnosis.


Exclusion Criteria:

  • Lack of early-onset osteoarthritis diagnosis.
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Mayo Clinic — Rochester, MN

Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression

A Study to Evaluate Stress Management and Resiliency Training vs. Treatment as Usual for Major Depression Treatment

Ashok Seshadri
All
25 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122674-H01-ALCL
19-009475
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Inclusion Criteria:

  • Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics at Rochester and Kasson, MN;, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin and Albert Lea, MN, with a diagnosis of major depression with a current moderate episode, with PHQ-9 scores 10-23.
  • Participants will be required to be between 25 and 80 years old.
  • Able to speak English.
  • Able to provide written informed consent to participate in the study.
  • Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013). 
  • Participants will continue taking any prescribed medications from their clinical treatment team. 
  • Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
  • Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
  • Participants are willing to use the Mayo Clinic Patient Portal for communication purposes during the study.


Exclusion Criteria:

  • Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
  • Participants with a severe major depressive episode- HAM-D scores ≥ 23.
  • Pregnant women – because of time duration of the study.
Behavioral
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Mayo Clinic Health System — Albert Lea, MN

Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression

A Study to Evaluate Stress Management and Resiliency Training vs. Treatment as Usual for Major Depression Treatment

Ashok Seshadri
All
25 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122674-H01-RST
19-009475
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Inclusion Criteria:

  • Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics at Rochester and Kasson, MN;, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin and Albert Lea, MN, with a diagnosis of major depression with a current moderate episode, with PHQ-9 scores 10-23.
  • Participants will be required to be between 25 and 80 years old.
  • Able to speak English.
  • Able to provide written informed consent to participate in the study.
  • Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013). 
  • Participants will continue taking any prescribed medications from their clinical treatment team. 
  • Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
  • Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
  • Participants are willing to use the Mayo Clinic Patient Portal for communication purposes during the study.


Exclusion Criteria:

  • Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
  • Participants with a severe major depressive episode- HAM-D scores ≥ 23.
  • Pregnant women – because of time duration of the study.
Behavioral
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Mayo Clinic — Rochester, MN

Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression

A Study to Evaluate Stress Management and Resiliency Training vs. Treatment as Usual for Major Depression Treatment

Ashok Seshadri
All
25 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122674-H01-AUAC
19-009475
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Inclusion Criteria:

  • Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics at Rochester and Kasson, MN;, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin and Albert Lea, MN, with a diagnosis of major depression with a current moderate episode, with PHQ-9 scores 10-23.
  • Participants will be required to be between 25 and 80 years old.
  • Able to speak English.
  • Able to provide written informed consent to participate in the study.
  • Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013). 
  • Participants will continue taking any prescribed medications from their clinical treatment team. 
  • Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
  • Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
  • Participants are willing to use the Mayo Clinic Patient Portal for communication purposes during the study.


Exclusion Criteria:

  • Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
  • Participants with a severe major depressive episode- HAM-D scores ≥ 23.
  • Pregnant women – because of time duration of the study.
Behavioral
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Mayo Clinic Health System — Austin, MN

Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression

A Study to Evaluate Stress Management and Resiliency Training vs. Treatment as Usual for Major Depression Treatment

Ashok Seshadri
All
25 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122674-H01-RWMC
19-009475
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Inclusion Criteria:

  • Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics at Rochester and Kasson, MN;, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin and Albert Lea, MN, with a diagnosis of major depression with a current moderate episode, with PHQ-9 scores 10-23.
  • Participants will be required to be between 25 and 80 years old.
  • Able to speak English.
  • Able to provide written informed consent to participate in the study.
  • Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013). 
  • Participants will continue taking any prescribed medications from their clinical treatment team. 
  • Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
  • Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
  • Participants are willing to use the Mayo Clinic Patient Portal for communication purposes during the study.


Exclusion Criteria:

  • Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
  • Participants with a severe major depressive episode- HAM-D scores ≥ 23.
  • Pregnant women – because of time duration of the study.
Behavioral
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Mayo Clinic Health System — Red Wing, MN

Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease (FLOW)

A Study to Evaluate How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease

Yogish Kudva
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122675-P01-RST
19-009477
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Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
    • Japan: Male or female, age above or equal to 20 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus.
  • HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol).
  • Renal impairment defined either by:
    • serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g; or 
    • serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g.
  • Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.


Exclusion Criteria:

  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
  • Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.
  • Presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Drug, Other
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Mayo Clinic — Rochester, MN

Monitoring Renal Transplant Rejection with Cell Free DNA

A Study to Monitor Renal Transplant Rejection with Cell Free DNA

Ann Moyer
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122677-H01-RST
19-009506
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Inclusion Criteria:

  • Adult patients, 18 years of age or older.
  • Renal transplant recipients undergoing renal biopsy to evaluate for graft function


Exclusion Criteria:
 

  • Patients under 18 years of age.

 

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Mayo Clinic — Rochester, MN

Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery (DoD FAI-2)

Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

Rafael Sierra
All
14 years to 40 years old
This study is NOT accepting healthy volunteers
0000-122678-P01-RST
19-009552
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Inclusion Criteria:

  • Age 14
    •40 years.
  • Skeletally Mature.
  • Failure of 6 weeks of conservative treatment.
  • Primary surgery (Hip Arthroscopic Treatment) a. Surgical treatment of FAI with hip arthroscopy.
  • Tonnis 0 -1 OA, with greater than 2 mm of joint space.
  • Clinical diagnosis of femoroacetabular impingement (FAI) (cam or combined; alpha > 50 degrees).


Exclusion Criteria:

  • Not a surgical candidate.
  • Skeletally Immature.
  • Acetabular Dysplasia (LCEA < 20).
  • Tonnis 2+ OA.
  • Previous ipsilateral hip surgery.
  • Previous major hip trauma (hip fractures, hip dislocations).
  • Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders).
  • Unable to consent due to mental faculty.
  • Pregnant women.
  • Non-English speaking patients.
  • Prisoners or other vulnerable populations.
Hip impingement, Hip pain
Arthroscopy, Femoral acetabular impingement, Hip arthroscopy, Musculoskeletal system
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Mayo Clinic — Rochester, MN

Biomarker Assessment of Patients with Osteonecrosis of the Femoral Head

A Study to Assess Biomarkers in Patients with Osteonecrosis of the Femoral Head

Rafael Sierra
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122687-H01-RST
19-009613
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Inclusion Criteria:

  • Subjects with target disease ONFH and OA.


Exclusion Criteria:
 

  • ONFH and OA subjects taking the medications statins, steroids, or TZDs will be excluded. 

 

Arthritis, Avascular necrosis, Osteoarthritis
Avascular necrosis of the head of femur, Musculoskeletal system, Osteoarthritis of hip
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Mayo Clinic — Rochester, MN

Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Michelle Lampman
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122694-H01-RST
19-009784
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Inclusion Criteria:

  • Discharged from hospital in the past 7 days or observation status.
  • Age ≥ 18 years.
  • LACE+ score ≥ 59 and at least two chronic conditions.
  • Index hospitalization with discharge directly to community dwelling (home, assisted living).
  • English speaking.
  • Discharge to home (residential dwelling) or assisted living, as appropriate and determined by the study coordinator.
  • Normal cognitive function. Mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment.
  • Mayo Clinic or Mayo Clinic Health System provider managing the patient’s care (e.g. primary care).  Patient is paneled to a Mayo Clinic MD/NP/PA.
  • Access to and ability to communicate via telephone and/or video (either patient or caregiver).


Exclusion Criteria:

  • Psychiatric hospital admission.
  • Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient’s clinic.
  • Untreated active substance or alcohol abuse.
  • Dementia or moderate to severe cognitive impairment.
  • Discharged to one of the following:
    • Rehabilitation unit;
    • Skilled nursing facility;
    • Assisted living memory unit;
    • Group home;
    • Transitional care unit.
  • Pregnancy.
  • Active treatment for cancer.
  • Receiving dialysis or transplant services.
  • Life expectancy < 6 months or enrolled in hospice or palliative care programs.
  • Patient is unwilling to sign a Release of Information (ROI) – (ROI allows those providing care, internal and external to be actively involved in patient’s care coordination).
  • Patients with active tuberculosis (TB).
  • Violent patient flag noted in Epic.
  • Patient is already enrolled in Remote Patient Monitoring or the Care Transitions Program (CTP), Palliative Care Homebound Program (PCHP), or Primary Care House Calls Program (PCHP), Advanced Care at Home (ACH) Program (NW WI).
  • Recent or active COVID patient (i.e., discharged from COVID admission, active COVID event)
  • Religious Sisterhood living at Mayo Clinic Hospital
    •St. Mary’s Campus or Assisi Heights (Rochester only).
  • Permanently living in a long-term care facility or a memory unit of an assisted living facility.
  • Chronic pain syndrome if chronic pain is the only diagnosis and no chronic medical condition exists.
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Mayo Clinic — Rochester, MN

The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 for Prevention of Proliferaivie Vitreoretinopathy (n/a)

The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

Raymond Iezzi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122697-P01-RST
19-009841
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Inclusion Criteria:

  • Subject is 18 years or older of any gender or race. 
  • Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury. 
  • Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits. 
  • Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial. 


Exclusion Criteria:

  • History of severe non-proliferative or proliferative diabetic retinopathy. 
  • Other planned eye surgery during the course of the trial. 
  • Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment.
Drug, Other
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Mayo Clinic — Rochester, MN

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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Mayo Clinic — Rochester, MN

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
Phase 2
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, Diagnostic Test, Procedure/Surgery
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, Head and brain 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.
  • Blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma).
  • 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 6/3/22. 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

Dawn Owen
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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A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis

A Study to Evaluate MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with Amyotrophic Lateral Sclerosis (ALS)

Nathan Staff
All
18 years to 80 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122926-P01-RST
19-011368
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Inclusion Criteria:
 

  • Written or verbal informed consent is obtained.
  • Male or female subjects age 18 to 80 years, inclusive.
  • Diagnosis of familial or sporadic AL as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory supported].
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • ALS onset of ≤ 18 months from first clinical signs of weakness prior to screening.
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • If currently using edaravone, subject should have completed the first 14 days of their initial treatment cycle prior to initiating study drug.
  • Documented ALS history of location of disease onset (i.e., bulbar onset, limb onset).
  • A total ALSFRS-R score of at least 35 overall at screening and:
    • No more than one of the 12 ALSFRS-R individual component items have a score of 1 or less at screening;
    • For limb onset subjects, ALSFRS-R score of ≥ 3 on item #1 (speech), #2 (salivation) and #3 (swallowing).
  • ALSFRS-R progression rate from onset of the first symptom of weakness to the ALSFRS-R score at Screening of ≥ 0.3 points and ≤ 1 point per month calculated as:
    • ALSFRS-R score at onset of first symptom of weakness (assume 48) minus ALSFRS-R score at Screening divided by number of months since onset of first symptom of weakness.
  • Documented pulmonary function test (PFT) result within the last 6 months (i.e., slow vital capacity or forced vital capacity) must be ≥ 70% of predicted. If subject does not have a documented PFT result within the last 6 months, they will be administered a PFT.
  • Female subjects of childbearing potential must use one or more effective methods of contraception throughout the entire study period and for 30 days after study drug discontinuation.
  • Male subjects agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire study period and for 30 days after study drug discontinuation.
  • Able to swallow study medication capsules.
  • Willing and able to comply with the protocol assessments and visits, in the opinion of the Investigator.
  • No known allergies to the study drug or its excipients.
  • At clinical sites where the pneumococcal vaccine is available and administered as standard of care, has received pneumococcal vaccine within 6 years prior to starting clinical trial.

Exclusion Criteria;

  • Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT > 3 times the upper limit of normal).
  • Currently has a clinically significant psychiatric disorder or dementia which would preclude evaluation of symptoms.
  • Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic including clinically significant chronic hepatitis, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, central nervous system infection or other active infection including a history of HIV (human immunodeficiency virus) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
  • Female subject is lactating, pregnant or planning pregnancy at Screening or Baseline.
  • History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or repeated demonstration of a QTc interval of > 450 ms in males and > 470 ms in females.
  • Past or current use of ibudilast.
  • Current use or treated with parenteral (intravenous or intramuscular) high-dose (> 25 mg/week) vitamin B12 (i.e., methylcobalamin, hydroxylcobalamin, cyanocobalamin, adenosyl cobalamin) within 30 days prior to study drug administration.
  • History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
  • History of alcohol or substance abuse (DSM-5 criteria) ≤ 3 months prior to screening or alcohol or substance dependence (DSM-5 criteria) ≤ 12 months prior to screening.
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
  • Currently participating, or has participated in, a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent.
  • Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator.
  • Use of tracheostomy or > 22/24h ventilatory support.

Eligibility last updated 10/13/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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