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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.

3802 Study Matches

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The Effect of Pars Plana Vitrectomy on Ocular Biomechanics and Aqueous Humor Dynamics

Pars Plana Vitrectomy Effect on Ocular Biomechanics and Aqueous Humor Dynamics

Arthur Sit
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309588-H01-RST
22-009830
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Inclusion Criteria:
 

  • ≥ 18 years of age.
  • Status post unilateral uncomplicated pars plana vitrectomy for epiretinal membrane or internal limiting membrane peel (i.e. for epiretinal membrane, vitreomacular traction, lamellar or macular hole).
  • The same phakic status in the fellow eye.


Exclusion Criteria:
 

  • Prior diagnosis of glaucoma, glaucoma suspect, or ocular hypertension.
  • Difference in lens status between the two eyes (phakic, pseudophakic, or aphakic).
  • Preoperative anisometropia greater than 2.5 diopters.
  • Current use of topical, oral, inhaled, injected, or other corticosteroids.
  • Abnormalities of the iridocorneal angle, including neovascular glaucoma, ICE syndrome, peripheral anterior synechiae, and plateau iris, among others.
  • Monocular status (fellow eye with visual acuity less than 20/100, or phthisical or enucleated/eviscerated fellow eye).
  • History of prior vitreoretinal surgery in either eye.
  • Pregnancy.
  • Inability to remain supine for the duration of testing.

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

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Bedside Echo in Hypoxemic Respiratory Failure and ARDS for the Evaluation of Right Ventricular Function (BEEHYVE)

A Study to Evaluate the Use of Bedside Echo for the Assessment of Right Ventricular Function in Hypoxemic Respiratory Failure and ARDS

Richard Oeckler
All
18 years and over
This study is NOT accepting healthy volunteers
0000-118812-H01-RST
16-005959
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Inclusion Criteria

  • For initial focused echocardiography (all must be yes )
    • ≥18 years of age
    • Is in ICU of MB6B/G at SMH or 10-3/10-4 at RMH
    • Meets the criteria of respiratory failure as above
  • For follow-up focused echocardiography (all must be yes )
    • Has undergone the initial focused echocardiography
    • Has had different modality of mechanical ventilation initiated and/or major changes were made to the current modality

Exclusion Criteria

  • For initial focused echocardiography (all must be no )
    • Hospitalized primarily for trauma
    • Underwent a thoracic surgical procedure within 48 hours of onset of dyspnea
    • Previously included in the study
    • Was transferred from an outside medical center for the treatment of respiratory failure ( the onset of the respiratory failure is not clear)
    • Has refused use of medical records for research purposes
    • Family members declined patient’s inclusion in the study
ARDS, Hypoxemia, Respiratory failure
Transthoracic echocardiogram, Acute respiratory distress syndrome, Echocardiogram, Hypoxemic respiratory failure, Mechanical ventilation, Respiratory system
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Mayo Clinic — Rochester, MN

The Underserved Population in Olmsted County and Integrative Health: A Survey (ZVHC)

A Study to Survey The Underserved Population in Olmsted County and Integrative Health

Brent Bauer
All
18 years and over
This study is NOT accepting healthy volunteers
2020-301211-H01-RST
20-006621
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Inclusion Criteria:

  • Undergoing an appointment at Zumbro Valley Health Center.
  • Willing and able to participate in the survey.
  • Able to speak, read, and understand English lanuguage.


Exclusion Criteria:

  • Decline to participate in the survey.
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Mayo Clinic — Rochester, MN

Exposure to C. Albicans during Early Life Predisposes Individuals to Atopy

C. Albicans during Early Life Predisposes Individuals to Atopy

Avni Joshi
All
up to 1 years old
This study is NOT accepting healthy volunteers
2022-309078-H01-RST
22-008236
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Inclusion Criteria:

  • Infants born via vaginal delivery at Mayo Clinic Rochester.
  • Infants must be followed by the Division of Pediatrics with follow-up routine prenatal care to be completed at Baldwin Building.
  • 25 infants will be at high risk for development of atopic dermatitis. High risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) of one of the following: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
  • 25 infants will be at low risk for development of atopic dermatitis. Low risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) without the presence of any of the following medical conditions: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
  • No underlying medical conditions at birth including underlying congenital medical conditions.


Exclusion Criteria:

  • Infants born via cesarean section delivery.
  • Infants followed by the Division of Family Medicine with routine follow-up prenatal care to be completed outside of Baldwin Building.
  • Presence of underlying medical conditions at birth including congenital medical conditions.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Patient Preference for an Implantable Device to Treat Liver Ascites

Liver Ascites Patient Treatment Preferences of Implantable Devices

Jody Olson
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309308-P01-RST
22-009292
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Inclusion Criteria:
 

  • Patients aged 18 years or older
  • Cirrhosis of liver defined by histological and/or clinical, endoscopic, laboratory, and radiological criteria.
  • Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis.
  • Not a candidate for (refused, contraindicated) TIPS or previously implanted TIPS is permanently obstructed or nonfunctioning.
  • Life expectancy of at least 6 months.
  • Capable of giving written informed consent and able to understand and complete the survey in English In addition, the clinics were asked to recruit a small number of patients who had received an implanted pump and would have satisfied the eligibility criteria above before receiving the implanted pump. The inclusion criteria for the online survey will be exactly as indicated for the pretest interviews, with the additions described as follows:  Received paracentesis more than 1 time in the last 30 days, confirmed by physician and patient report.
  • Stage 0 hepatic encephalopathy, confirmed by physician report.
  • Ascites symptoms Stage 1, 2, or 3, confirmed by physician report.
  • Has a life expectancy of at least 6 months, confirmed by physician report 6 Therapeutic paracentesis is defined as removal of at least 1.5 L of ascitic fluid by means of percutaneous drainage with therapeutic intent in patients with symptoms related to fluid accumulation or clear evidence of ascites accumulation (weight gain, abdominal circumference), excluding patients receiving a puncture for diagnostic purpose only. Patient Preference for an Implantable Device to Treat Liver Ascites: Final Protocol 35.
  • At least half the sample will include patients who are not candidates for (refused, contraindicated) TIPS or in whom a previously implanted TIPS is permanently obstructed or nonfunctioning.


Exclusion Criteria:

  • Patients who have been enrolled to participate in the clinical trial for the alfapump, including people who have been enrolled but have not been implanted with an alfapump or are no longer implanted.

Eligibility last updated 8/29/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Cardiac MRI in Patients with Congenital Heart Disease

CMRI in CHD

Alexander Egbe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306664-H01-RST
21-012984
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Inclusion Criteria:

  • Individuals 18+ years of age.
  • Capable of consent.
  • Diagnosis of a Congenital Heart Disease.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Unable to consent.
  • Unable to undergo a cardiac MRI.

Eligibility last updated 12/21/21. Questions regarding updates should be directed to the study team contact.

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The Role of the Comprehensive Geriatric Assessment in Elderly Patients with Multiple Myeloma: a Single Center Prospective Study

The Impact of a Geriatric Assessment in Elderly Patients with Multiple Myeloma

Shaji Kumar
All
65 years and over
This study is NOT accepting healthy volunteers
2021-306137-P01-RST
21-010499
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Inclusion Criteria:

  • Age ≥ 65 years.
  • Diagnosis of MM based on IMWG diagnostic criteria 64.
  • Newly diagnosed or have received 1 prior line of treatment.
  • Planned to start a new treatment for MM within 30 days.
  • Transplant eligible or ineligible.
  • Fluent in English (all assessment tools are in English).
  • Able to provide written informed consent.


Exclusion Criteria:

  • Received > 1 prior line of treatment.
  • Patients included in an interventional therapeutic trial.
  • Not able to give informed consent.
  • Severe mental or cognitive disorder precluding geriatric assessment.

Eligibility last updated 1/20/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Determining How Indoor Lighting Affects the Brain Health of Older Adults

Indoor Lighting's Affects on the Brain Health of Older Adults From

Ying Ying Chen
All
60 years and over
This study is NOT accepting healthy volunteers
2022-308283-P01-RST
22-005400
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Inclusion Criteria:

  • At least age 60.
  • Able to wear wearable devices throughout the study.
  • Willing to have their lighting in their kitchen and dining areas changed and controlled for the study.
  • Willing to have environmental sensors placed in their residence.
  • Able to provide informed consent.


Exclusion Criteria:

  • Have severe sleep disturbance (as diagnosed by a clinician or based on a sleep assessment such as the Berlin Questionnaire) unless partner is eligible and participating in this study.
  • Legally blind.
  • History of diagnosed moderate to severe cognitive impairment (as diagnosed by a physician or based on a cognitive assessment such as the Kokmen Short Test of Mental Status) unless partner is eligible and participating in this study.
  • Renovated their living units and no longer have the standard lighting installation offered by the Senior Living Facility.
  • Spend or plan to spend > 5 hours per day outside of their residence during the study.
  • Plan to be away from their residence for more than a week during the study.

Eligibility last updated 10/27/23. Questions regarding updates should be directed to the study team contact.

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Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Matthew Abdel
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308626-H01-RST
22-006739
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Inclusion Criteria:
 

  • Patients ≥ 18 years or older. 
  • Patients who speak English and are willing to sign the consent form
  • Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 3 months from surgery; symptoms < 3 weeks in duration) of a total knee or total hip arthroplasty, defined as:
    • A sinus communicating with the prosthesis OR
    • Two positive cultures obtained from the prosthesis OR
    • 4 of 5 criteria:
      • Elevated ESR (> 30mm/hr) and CRP (> 10mg/L);
      • Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on;
      • leukocyte esterase strip;
      • Elevated synovial neutrophil percentage (> 80%);
      • One positive culture;
      • Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high;
      • Power field in 5 high power fields x 400).
  • OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR


Exclusion Criteria:

  • Patients with a chronic PJI, defined as:
    • Presentation of symptoms > 4 weeks in duration.
  • Revision surgery or previous two-stage reimplantation.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

 

Drug, Procedure/Surgery
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Mayo Clinic — Rochester, MN

A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety and Tolerability of JK07 in Subjects With Heart Failure With Preserved Ejection Fraction (HFpEF)

Single-Ascending Dose Study of JK07 in Subjects With HFpEF

Atta Behfar
All
18 years to 85 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-309423-P01-RST
22-009548
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Inclusion Criteria:


1. Stable New Yok Heart Association (NYHA) Class II or III HF diagnosis, evident at least
6 months prior to enrollment as confirmed by medical history.

2. Documented prior objective evidence of heart failure as shown by 1 or more of the
following criteria:

1. Previous hospitalization for heart failure with documented radiographic evidence
of pulmonary congestion.

2. Elevated left ventricular (LV) end-diastolic pressure or pulmonary capillary
wedge pressure at rest (≥15 mm Hg) or with exercise (≥25 mm Hg).

3. Elevated level of NT-proBNP (>400 pg/mL) or brain natriuretic peptide (BNP) (>200
pg/mL).

4. Echocardiographic evidence of medial E/e' ratio ≥ 15 or Left Atrial Volume (LAV)
>58 mL in male patients or >52 mL in female patients.

3. Adequate acoustic windows on screening resting TTE

4. Documented structural abnormality consistent with HFpEF confirmed at the screening
visit by clearly interpretable echocardiography assessment.

5. Meets 1 or more of the following criteria at the initial screening measurement:

1. A hs-cTnI >99th percentile

2. NT-proBNP >300 pg/mL (if not in atrial fibrillation or atrial flutter) or >600
pg/mL (if in atrial fibrillation or atrial flutter), or if the screened
participant is either of African descent or has a body mass index ≥30.0 kg/m2, a
screening NT-proBNP >240 pg/mL (if not in atrial fibrillation or atrial flutter)
or >480 pg/mL (if in atrial fibrillation or atrial flutter).

6. Body mass index (BMI) ≥18 kg/m2 and ≤45 kg/m2

7. Screening hemoglobin ≥9.0 g/dL, platelets ≥100x109 /mL, absolute neutrophil count
(ANC) ≥1500/mL.

8. Sexually mature biological male subjects must agree to use a medically accepted method
of contraception throughout the study and be willing and able to continue
contraception until the end of the study (6-month time point).

9. Biological females of childbearing potential must present with a negative blood
pregnancy test, must not be lactating, and must agree to employ adequate birth control
measures for the duration of the study and be willing and able to continue
contraception until the end of the study (6-month time point).

10. Subject is capable of giving signed informed consent.

11. Subject is willing and able to comply with the requirements of the protocol.


Exclusion Criteria:


Cardiac-Related

1. Participating in any other study and have received any other investigational drug
within 30 days prior to screening or 5-half-lives, whichever is longer, or any other
investigational implanted device within 30 days prior to screening, or are taking part
in a nonmedication study which, in the opinion of the Investigator, would interfere
with study compliance or outcome assessments.

2. Any past participation in a study that has investigated the NRG-1 pathway (e.g.,
Neucardin, cimaglermin).

3. Has a prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or
storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry
disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation
result.

4. Has a history of syncope within the last 6 months or sustained ventricular tachycardia
with exercise within the past 6 months.

5. Has persistent or permanent atrial fibrillation and is not therapeutically
anticoagulated for at least the 4 weeks prior to the initial screening visit or is not
adequately rate controlled within 6 months prior to informed consent according to
investigator discretion.

6. Has known moderate or severe aortic valve stenosis, hemodynamically significant mitral
stenosis, or severe mitral or tricuspid regurgitation at informed consent.

7. Has severe chronic obstructive pulmonary disease, or other severe pulmonary disease,
requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy or
hospitalized for pulmonary decompensation within 12 months of informed consent.

8. Diagnosed with medically documented acute coronary syndrome within 3 months of
screening or a medically documented acute myocardial infarction within 6 months of
screening.

9. Cardiac surgery, coronary artery revascularization, percutaneous coronary
intervention, or valvuloplasty within 3 months prior to screening.

10. Any subject who has received an indication for coronary revascularization within 3
months prior to screening.

11. Any of the following confirmed by duplicate seated determinations on at least 3
consecutive readings (in clinic/office) following informed consent and prior to
randomization:

1. Systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP)
>100 mmHg

2. Sustained SBP <90 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension

3. Sustained resting heart rate (HR) <50 or ≥100 bpm or >110 bpm if chronic AF at
Screening (Visit 1) or prior to randomization for >15 minutes in two episodes
separated by one hour of observation

12. Cerebrovascular accident or hospitalizations for cardiovascular (CV) causes other than
routine percutaneous procedures (such as device, battery, generator changes or
pacemaker lead insertion/replacement), including HF, chest pain, stroke, transient
ischemic attack, or arrhythmias within 3 months prior to screening.

13. Symptomatic carotid stenosis or transient ischemic attack or stroke within 60 days
prior to informed consent.

14. Has a history of resuscitated sudden cardiac arrest or a known history of appropriate
implantable cardioverter-defibrillator (ICD) discharge for life-threatening
ventricular arrhythmia. (Note: history of anti-tachycardia pacing (ATP) is allowed.)

15. Subjects at screening have an abnormal or clinically significant 12-lead ECG
abnormality, that, in the opinion of the Investigator, would affect efficacy or safety
evaluation or place the subject at risk.

16. History or evidence of clinically significant arrhythmias uncontrolled by drug therapy
or use of an implantable defibrillator, long QT syndrome, or evidence of QT
prolongation with QTcF >450 ms for males or QTcF >470 ms for females during screening
and/or prior to randomization.

Non-Cardiac Co-Morbidity

17. Clinically significant renal dysfunction as measured by the estimated glomerular
filtration rate of <45 mL/min/1.73m2 as calculated by local laboratory standards
(Cockcroft-Gault equation for estimation of creatinine clearance [CrCl] [Cockcroft and
Gault 1976]) at screening, or a clinically significant change in renal function
between screening and baseline.

18. Clinically significant liver dysfunction as measured by: alanine aminotransferase
(ALT) >2.0 × the upper limit of normal (ULN), alkaline phosphatase > 2.0 × ULN,
aspartate aminotransferase (AST) >2.0 × ULN, or gamma glutamyl transferase (GGT) >2.0
× ULN or serum bilirubin ≥ 1.5 × ULN at screening, or a clinically significant change
in liver function between screening and baseline.

19. Subjects with alteration of the coagulation panel (international normalized ratio
[INR]) and/or prothrombin time (PT) ≥1.5 × the ULN; activated partial thromboplastin
time (aPTT) ≥1.5 × ULN, or serum albumin ≤3 gm/dL. For subjects on warfarin or other
anticoagulants, an INR (or PT) considered by the Principal Investigator as
therapeutically appropriate will be allowed.

20. Any subject who by Investigator's judgement, has a significant hematuria or
proteinuria at screening.

21. Concurrent treatment with Class Ia or III antiarrhythmic drugs if the dosage has been
adjusted within 2 months prior to informed consent.

22. Positive screening for human immunodeficiency virus antibodies, hepatitis B surface
antigen, or hepatitis C virus antibodies.

23. Known history of or active alcohol abuse (no more than 14 units/week for males or 7
units/week for females) or use of illicit drugs within 1 year prior to randomization
(excluding recreational use of marijuana or cannabidiol [CBD]-based products).

24. Other medical or psychiatric condition that, in the opinion of the Investigator, would
preclude obtaining voluntary consent/assent or would confound the secondary objectives
of study.

25. A history of pathologically confirmed malignancy of any type or any pathologically
confirmed pre-malignant condition (e.g., ductal carcinoma in situ, colonic polyp with
premalignant diagnosis, or cervical atypia). All subjects are to undergo cancer
screening following study enrollment in accordance with American Cancer Society
Guidelines (See Appendix 1).

26. Pregnant or lactating at screening.

27. Subjects with clinically significant or poorly controlled disease including, but not
limited to, endocrine (including diabetes and thyroid) disease, pulmonary (requires
home oxygen, inhalants, steroids >10 mg prednisone equivalent or 2x baseline
physiologic steroid replacement, primary pulmonary hypertension, history of pulmonary
emboli), neurological or psychiatric (even mild), GI, hematological, urological,
immunological, ophthalmic, or orthopedic diseases as determined by the Investigator.

28. Any major surgical procedure within 1 month prior to screening or planned surgical
procedure during the study period.

29. Subjects who are not non-smokers or light smokers (no more than 5 cigarettes per day)
and who cannot abstain from smoking from 2 weeks prior to the administration of IP
through the end of the study.

30. Subjects with orthopedic impairment which would prohibit credible or adequate
assessment of 6MWT.

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

Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

All
1 Year and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05179057
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Inclusion Criteria:

• Male or female 1 year of age or older
• Undergone allogeneic cell transplantation ≥21 days prior to dosing
• Meet one of the below criteria: 1. AdV viremia DNA ≥10,000 copies/mL, OR 2. AdV viremia DNA results of ≥1,000 copies/mL, AND 1. has absolute lymphocyte count <180/mm3, OR 2. has received T cell depletion OR 3. had a cord blood transplant.
Exclusion Criteria:

• Grade >2 acute GVHD
• Ongoing therapy with high-dose systemic corticosteroids
• Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
• Pregnant or lactating female unwilling to discontinue nursing prior to randomization
• History of severe prior reactions to blood product transfusions. NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
Drug: Posoleucel, Drug: Placebo
Adenovirus Infection
Allogeneic Hematopoietic Cell Transplant, Adenoviremia, Adenovirus, Stem Cell Transplant, Posoleucel, ALVR105, Bone Marrow Transplant
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University of Minnesota — Minneapolis, Minnesota

CHIlled Platelet Study "CHIPS" (CHIPS)

All
29 Days to 84 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04834414
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Inclusion Criteria:

• Age greater than 28 days and less than 85 years
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:

• Expected order for washed or volume reduced platelets
• Patient with known anti-platelet antibodies
• Platelet transfusion refractoriness due to anti-HLA antibodies
• Known or suspected pregnancy
• Previously randomized in this study
• Conscious objection or unwillingness to receive blood products
• Known IgA deficiency
• Known congenital platelet disorder
• Known congenital bleeding disorder
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
• Patients intended to receive whole blood either intra-operative or post-operative for bleeding
• Platelet transfusion (of any type) within 24 hours prior to the date of surgery
• Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.
Biological: Cold Stored Platelets, Biological: Room Temperature Platelets
Acute Blood Loss
platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery
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University of Minnesota — Minneapolis, Minnesota Therese Chlebeck

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP)

Female
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04486352
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Key
Inclusion Criteria:

• Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be counted as a systemic therapeutic regimen.
• Measurable disease per RECIST 1.1
• Availability of a representative tumor specimen that is suitable for determination of biomarker status via central testing (F1CDx) OR If a patient has a prior F1CDx report from 1 September 2019 or later, those NGS results can be used to determine biomarker status as long as the tumor tissue used in the report was obtained within 5 years prior to prescreening and appropriate signed consent is obtained from the patient.
• Life expectancy > 12 weeks
• Recovery from effects of recent radiotherapy, surgery, or chemotherapy Key
Exclusion Criteria:

• Endometrial tumors with the following histologies: squamous carcinomas, sarcomas
• Other invasive malignancies within the last 5 years, except for non-melanoma skin cancer with no evidence of disease within the past 5 years AND localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago
• Synchronous primary invasive ovarian or cervical cancer
• Have an active or history of autoimmune disease or immune deficiency
• Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan
• Active tuberculosis
• Severe infections within 4 weeks
• Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication
• Have significant cardiovascular disease
• Are administered treatment with a live attenuated vaccine within 4 weeks, or anticipation of need for such a vaccine during the course of the study
• Have prior allogeneic bone marrow transplantation or solid organ transplant
• Prior treatment with T-cell costimulating or immune checkpoint blockade therapies including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapeutic antibodies
• History of treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
• History of treatment with systemic immunosuppressive medications within 2 weeks except acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose corticosteroids for participants with orthostatic hypotension or adrenocortical insufficiency
• Have a history or clinical evidence of any untreated CNS disease, seizures not controlled with standard medical therapy, or history of cerebrovascular accident (stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months Note: Additional study cohort specific inclusion and exclusion criteria may apply based on cohort assignment.
Drug: Atezolizumab - 28 Day Cycle, Drug: Bevacizumab, Drug: Ipatasertib, Drug: Talazoparib, Drug: Trastuzumab emtansine, Drug: Tiragolumab, Drug: Atezolizumab - 21 Day Cycle, Drug: Inavolisib, Drug: Letrozole, Drug: Giredestrant, Drug: Abemaciclib
Endometrial Cancer
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University of Minnesota — Minneapolis, Minnesota Britt Erickson, MD

Urinary crystal burden as a biomarker for predicting disease progression in pediatric patients with autosomal dominant polycystic kidney disease (ADPKD)

Predicting Disease Progression in Pediatric Patients With Autosomal Dominant Polycystic Kidney Disease Using Urinary Crystal Burden as a Biomarker

Christian Hanna
All
5 years to 18 years old
This study is NOT accepting healthy volunteers
2022-309197-H01-RST
22-010623
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Inclusion Criteria:

  • Any autosomal dominant polycystic kidney disease (ADPKD) patient (ages 5-18 years) with confirmed ADPKD (via a combination of imaging, family history, and/or genetic testing), identified from existing and newly identified families for the proposed study.
  • Matched controls will be identified as unaffected siblings, unaffected family members of ADPKD subjects, or children recruited from the outpatient primary care clinics.


Exclusion Criteria:
 

  • ADPKD patients with liver and or kidney transplant.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

3D Ultrasound Imaging of the Axillary Lymph Nodes

3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer

Shigao Chen
Female
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2022-308590-H01-RST
22-006606
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Inclusion Criteria:


- Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care.

- Age of 18 or older.


Exclusion Criteria:


- Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Diagnostic Test
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A Biobank for Functional Gastrointestinal Disorders (FGID)

A Biobank for Functional Gastrointestinal Disorders (FGID)

Purna Kashyap
All
18 years and over
This study is NOT accepting healthy volunteers
0000-112618-H01-RST
12-000948
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Inclusion Criteria:

  1. Adult patients attending any of the gastroenterology or other medical outpatient clinics at the Rochester campus with a diagnosis of any functional gastrointestinal disorder (FGID) will be eligible for enrollment
  2. Age ≥ 18


Exclusion Criteria:

  1. Individuals who do not comprehend English (i.e., participants must be able to read and sign a consent form without the assistance of an interpreter)
  2. Age <18
  3. Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent)
  4. Individuals regarded as belonging to a vulnerable population (e.g., prisoners)
  5. Patients will be ineligible to deposit a stool sample if they have had antibiotics within the last month, they can however deposit fecal samples after a washout period
  6. Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, would increase risks, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
Constipation, Diarrhea, Indigestion, Irritable bowel syndrome, Nonulcer stomach pain
Digestive system, Functional disorder of gastrointestinal tract
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Care processes promoting person-centred care according to patients diagnosed with neuroendocrine tumours (NETs)

Care Processes and Person Centered Care of Patients with Neuroendocrine Tumors

Thorvardur Halfdanarson
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2020-301569-P01-RST
20-007135
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Key

Inclusion Criteria:

  • Adult patients (≥ 18 years old);
  • Patients with euroendocrine tumors willing to participate in a telephone interview.

Key


Exclusion Criteria:

  • Concomitant non-euroendocrine cancer undergoing active therapy (ongoing chemotherapy, radiation therapy, or hormonal therapy).
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A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (SEQUOIA-HCM)

CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM

Jeffrey Geske
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-307403-P01-RST
22-002117
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Key

Inclusion Criteria:


- Males and females between 18 and 85 years of age, inclusive, at screening.

- Body mass index <35 kg/m2.

- Diagnosed with HCM per the following criteria:

- Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac
disease and

- Has an end-diastolic LV wall thickness as measured by the echocardiography core
laboratory of:

- ≥15 mm in one or more myocardial segments OR

- ≥13 mm in one or more wall segments and a known-disease-causing gene
mutation or positive family history of HCM

- Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as
determined by the echocardiography core laboratory.

- LVEF ≥60% at screening as determined by the echocardiography core laboratory.

- NYHA Functional Class II or III at screening.

- Hemoglobin ≥10g/dL at screening.

- Respiratory exchange ratio (RER) ≥1.05 and pVO2 <80% predicted on the screening CPET
per the core laboratory.

- Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on
stable doses for >6 weeks prior to randomization and anticipate remaining on the same
medication regimen during the trial. Patients treated with disopyramide must also be
concomitantly treated with a beta blocker and/or calcium channel blocker.

Key
Exclusion Criteria:


- Known or suspected infiltrative, genetic or storage disorder causing cardiac
hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).

- Significant valvular heart disease (per investigator judgment).

- Moderate-severe valvular aortic stenosis.

- Moderate-severe mitral regurgitation not due to systolic anterior motion of the
mitral valve.

- History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time
during their clinical course.

- Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations).

- Has been treated with septal reduction therapy (surgical myectomy or percutaneous
alcohol septal ablation) or has plans for either treatment during the trial period.

- Documented paroxysmal atrial fibrillation during the screening period.

- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg,
direct-current cardioversion, atrial fibrillation ablation procedure, or
antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply
if atrial fibrillation has been treated with anticoagulation and adequately
rate-controlled for >6 months.)

- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
months prior to screening.

- Has received prior treatment with CK-3773274 or mavacamten.

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

Eligibility last updated 5/31/23. Questions regarding updates should be directed to the study team contact.

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SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor (ACSPIRE)

SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

Irina Bancos
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307993-P01-RST
22-004489
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Main

Inclusion Criteria:

  • Adult participants able to give informed consent and willing to adhere to necessary reproductive precautions.
  • Participants with benign adrenal lesions(s) with proven ACS (clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines).
  • Participants should have documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, osteopenia, attributable to clinically significant hypercortisolism.
  • Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical or medical therapy(ies) approved in their region of residence.

Main


Exclusion Criteria:

  • Participants with adrenal Cushing’s syndrome (aCs) will be excluded.
  • History of adrenalectomy or planned adrenalectomy within 4 months after enrollment.
  • Hypercortisolism which is exogenous including ACTH-dependent, cyclical, intermittent, or physiological (a.k.a. pseudo-Cushing’s).
  • Participants who plan to undergo curative adrenal surgery within the next 3 years.
  • History of idiopathic thrombocytopenia.
  • History of cancer within 3 years likely to require further testing or intervention during the trial period or associate with a poor prognosis (e.g., other than treatable skin, thyroid, or early-stage prostate cancer, please consult with Medical Monitor for others).
  • Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
  • Pregnant or lactating.
  • Other medical contraindications to SPI-62 therapy or other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
  • Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
  • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.

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

Eligibility last updated 9/20/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Upper Extremity Function When Using a Powered Exoskeleton (UE Exo)

A Study to Assess Upper Extremity Function Using a Powered Exoskeleton

Kenton Kaufman
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
2020-301316-H01-RST
20-006849
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Inclusion Criteria:

  • Age 18-65 years.
  • Patients with injuries resulting in loss of elbow flexion, in particular a traumatic brachial plexus injury.
  • Functional passive range of motion of the involved upper extremity.
  • Able to follow simple directions.
  • Willingness to participate in the study.
  • No restriction will be placed on gender, race, or ethnicity.


Exclusion Criteria:

  • Under 18 and over 65 years of age.
  • Closed head injury with resultant inability to follow commands.
  • Soft tissue or skeletal injuries which preclude use of an orthosis.
  • Non-functional passive range of motion.
  • Neuropathic pain which prevents use of a powered exoskeleton.
  • Unwillingness or inability to comply with test procedures.

 

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Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE)

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE Trial)

Randall DeMartino
All
20 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308883-P01-RST
22-007572
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Inclusion Criteria:


- Subject and the treating physician agree that the subject will return for all required followup visits.

- Subject or legal representative or consultee, as applicable, has consented for study participation and signed the Informed Consent approved by the sponsor and by the
Ethics Committee/Institutional Review Board.

- Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man).

- Subject's AAA anatomy is appropriate for both Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both
treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.


Exclusion Criteria:


- Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study.

- Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator.

- Subject has an aneurysm that is:

1. Suprarenal/pararenal/juxtarenal

2. Isolated ilio-femoral;

3. Mycotic;

4. Inflammatory;

5. Pseudoaneurysm;

6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries;

7. Ruptured, including leaking;

8. Symptomatic AAA.

- Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck. Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.

- Subject requires emergent aneurysm treatment, for example, trauma or rupture.

- Subject with connective tissue disease that may have caused the aneurysm; e.g., Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome.

- Subject has previously undergone surgical treatment for abdominal aortic aneurysm.

- Planned use of aorto-uni-iliac (AUI) main body device.

- Any planned additional device during index procedure (e.g., endostaple or anchor, Iliac branch endoprosthesis, sac or side branch embolization etc.).

- Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m^2 or subject is on dialysis.

- Subject has a systemic infection who may be at increased risk of endovascular graft infection.

- Subject has a psychiatric or other condition that may interfere with the study.

- Subject is a female of childbearing potential in whom pregnancy cannot be excluded.

- Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.

- Subject belongs to a vulnerable population per investigator's judgment.

- Subject has an active COVID-19 infection or relevant history of COVID- 19.

Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.

Device
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Assessment of Novel Hyperphagia Questionnaires to Identify Variants in MC4R Pathway-Associated Obesity

Identifying Variants in MC4R Pathway-Associated Obesity With Novel Hyperphagia Questionnaires

Seema Kumar
All
6 years to 26 years old
This study is NOT accepting healthy volunteers
2022-309356-P01-RST
22-009266
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Inclusion Criteria:

  • Patients who are or will be included in POWER registry.
  • Patients aged 6 to 26 years at time of recruitment for the current study.
  • Patients who satisfy the criteria for early-onset obesity:
    • Criteria to identify early-onset obesity among patients aged 6 to 26 years will be consistent with the criteria used for the Uncovering Rare Obesity® Program, as follows:
      • For patients aged 6 to 18 years at study recruitment::
      • The patient’s body mass index (BMI) is ≥ 97th percentile at recruitment based on the Centers for Disease Control (CDC) charts, and;
      • The patient has early-onset obesity.
      • Early-onset obesity will be determined based on historical records of weight, height, age, and gender in the electronic medical record or patient chart using the following definitions:
      • Historical measurements from age < 2 years: sex-specific weight for recumbent length is ≥ 97.7th percentile on the World Health Organization (WHO) charts.
      • Historical measurements from age 2-5 years: BMI ≥97th percentile based on the CDC charts.
      • Only patients with verified weight and height information before the age of 6 years and who meet the criteria of early-onset obesity will be included in the study. For new patients without available measurements to confirm early-onset obesity (electronic medical record, patient chart and/or POWER data), at least 1 weight and height measurement prior to the age of 6 years will be obtained by the study investigator at each participating site (either from the electronic medical record or from the patient’s primary care provider).
      • For patients aged ≥ 18 years at study recruitment:
      • The patient’s BMI is ≥ 40 kg/m^2 at recruitment AND
      • The patient has early-onset obesity (as defined above), as documented in the electronic medical record or patient chart.


Exclusion Criteria:
 

  • Patients with prior testing for variants in the 36 genes of interest.
  • Patients who have any of the following potential causes of secondary obesity:
    • Endocrine diagnoses (e.g., hypothyroidism, Cushing syndrome, growth hormone [GH] deficiency);
    • Neurologic diagnoses.;
    • Intracranial injury (including, but not limited to: tumor, trauma, surgery, pituitary resection, irradiation);
    • Hypothalamic obesity;
    • Medication-induced weight gain, as determined by the Investigator.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

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A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients With Treatment-refractory Mycobacterium Avium Complex Lung Disease (MACrO2)

Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease

Patricio Escalante
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-307877-P01-RST
22-004633
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Inclusion Criteria:


1. Male or female patients who are 18 years of age or older.

2. Willing and able to provide written informed consent.

3. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all
of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria:

1. Microbiological criteria:

- One Pre-Study MAC-positive respiratory specimen. Documentation of a MAC
positive specimen collected per standard of care within 6 months of
screening.

- One Screening MAC-positive expectorated or induced sputum sample.

2. Clinical criteria: At least 2 of the following patient-reported clinical
symptoms:

- Cough with sputum production

- Cough without sputum

- Chest congestion

- Hemoptysis

- Dyspnea

- Fatigue

- Night sweats or unusual sweating

3. Radiographic criteria: Chest CT scan within 8 weeks prior to randomization with
abnormalities consistent with MAC lung disease.

4. Patients who are willing to comply with all the study activities and procedures
throughout the duration of the study and comply with all planned study visits and
study procedures from Screening through the LFU Visit.

5. All patients must agree to use an effective method of birth control.

6. Patients expected to survive with continued antimycobacterial therapy and appropriate
supportive care from Screening through the LFU Visit, in the judgment of the
Investigator.


Exclusion Criteria:


1. Patients with a presence of any suspected or confirmed disease or condition at
Screening or the time of randomization that, in the opinion of the Investigator, may
confound the assessment of symptom-based clinical response.

2. Patients with active pulmonary malignancy or any malignancy that required or would
require chemotherapy or radiation therapy within 1 year prior to randomization through
the LFU Visit.

3. Patients with creatinine clearance (CrCl) of ≤50 mL/min, as estimated by the Cockcroft
Gault formula, at Screening or at the time of randomization.

4. Patients with hemoglobin <10.0 g/dL or <6.2 mmol/L at Screening; donation of blood or
plasma within 28 days prior to randomization; or symptomatic loss of blood or
hemorrhage within 28 days prior to randomization.

5. Patients with severe hemoptysis within 28 days prior to randomization, defined as >100
mL over any 24-hour period or severe or extremely severe hemoptysis.

6. Patients with severe hepatic impairment, as evidenced by alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN) or total
bilirubin >2 × ULN, or clinical signs of cirrhosis or end-stage hepatic disease.

7. Patients who are pregnant or breastfeeding.

8. Patients with a mean QT interval corrected using Fridericia's formula (QTcF) >480 msec
based on triplicate 12-lead ECGs at Screening.

9. Patients with an immunodeficiency or an immunocompromised condition and risk for an
opportunistic pulmonary infection.

10. Patients with an anticipated start of new non-study antimycobacterial therapy to be
administered at any time between Screening and Month 6.

11. Patients who have received any investigational medication during the 30 days or 5 half
lives, whichever is longer, prior to randomization.

12. Patients with any prior exposure to epetraborole.

13. Patients with any condition that, in the opinion of the Investigator, interferes with
the ability to safely complete the study or adhere to study requirements, including
the patient's inability or unwillingness to comply with all study assessments and
visits.

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

Eligibility last updated 4/26/23. Questions regarding updates should be directed to the study team contact.

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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial

myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home

Megan Dulohery Scrodin
All
30 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308363-P01-RST
22-006259
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Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Male or female, aged 30 years or greater.

4. FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II
•IV, Grade E).

? Spirometry performed during the screening visit will be used to confirm GOLD stage.  A prior spirometric test within the past 6 months can be substituted if available.

5. MRC ≥ 2 or CAT ≥ 10.

6. Former smokers or current smokers and never-smokers are eligible for study inclusion.

? Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device

7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks.

8. COPD in a stable state after hospitalization defined as:

- Clinically stable condition and have had no parenteral therapy for 24 hours.

- Inhaled bronchodilators are required less than four-hourly.

- Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).

- If previously able, the patient is ambulating safely and independently, and performing activities of daily living.

- The patient can eat and sleep without significant episodes of dyspnea.

- The patient or caregiver understands and can administer medications.

- Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.

9. Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device.

10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis.

11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study
participation.

Highly effective contraception is defined as:

- A tubal ligation:

- An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices.

12. Able to read and communicate in English.

13. Have a home environment suitable for myAirvo 3 use.

14. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
•refraining from smoking while receiving supplemental oxygen or the
myAirvo-3 device.


Exclusion Criteria:


An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV).

2. A STOPBang Questionnaire score > 5*.

* subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.


3. Pregnancy or lactation.

4. Treatment with another investigational drug or other intervention within the previous 30 days.

5. Life expectancy less than 12 months due to COPD or other comorbid condition.

6. Recent upper airway surgery (within the previous month).

7. Recent head or neck trauma (within the previous month).

8. Inability to tolerate nasal prongs.

9. Requirement of oxygen greater than 15 L/min

- subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.

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

Eligibility last updated 10/18/23. Questions regarding updates should be directed to the study team contact.

Device, Heated and humidified high flow oxygen therapy, Oxygen administration by nasal cannula
COPD
Chronic obstructive lung disease, Respiratory system
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Fostering Caregiver Connections via Intentional Technology Pairing for Caregivers of Patients with Alzheimer’s Disease and Other Types of Dementia—Phase 2 (C2C)

A Study to Evaluate Caregiver Connections via Technology for Patients with Alzheimer's and Other Types of Dementia

Julie Fields
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309221-P01-RST
22-008835
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Inclusion Criteria:

  • The participant must have a family member that has been diagnosed with one of the following forms of dementia:
    • Parkinson’s/Lewy body dementia;
    • Any frontotemporal lobar degeneration dementia; or
    • Alzheimer’s dementia.
  • The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
  • The participant must have been caring for their loved one with dementia for at least 3 months. 
  • All participants must have access to a computer and be able to use the internet.
  • All participants must be English speaking.
  • All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief “virtual” interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
  • All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.


Exclusion Criteria:
 

  • Care Partner’s loved one does not have a confirmed diagnosis of dementia.
  • Care Partner is unable to provide consent.
  • Care Partner was or has been in that role for less than 3 months.

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

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

Other, Behavioral
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IDENTIFICATION OF METHYLATED DNA MARKERS IN INVASIVE BLADDER CARCINOMA: WHOLE METHYLOME DISCOVERY, TISSUE VALIDATION, AND FEASIBILITY TESTING IN BLOOD AND URINE

Blood and Urine Identification of Methylated DNA Markers in Invasive Bladder Carcinoma

John Kisiel
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309683-H01-RST
21-009811
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Inclusion Criteria
•Case Tissue:

  • Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.
  • Age ≥ 18 years.

Exclusion Criteria
•Case Tissue:

  • Patient has a recurrence of bladder cancer.
  • Patient has undergone any prior radiation therapy (including brachytherapy therapy) to target lesion prior to surgery.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.

Inclusion Criteria Control Tissue:

  • Patient is undergoing prostatectomy.  
  • Age ≥ 18 years.

Exclusion Criteria
•Control Tissue:

  • Patient has undergone any prior radiation therapy (including brachytherapy therapy) to the bladder prior to surgery.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.
  • Patient has had bladder, urothelial or kidney cancer

Inclusion Criteria
•Control Buffy:

  • Age ≥ 18 years.

Exclusion Criteria
•Control Buffy:

  • Patient has known primary cancer within the last 5 years prior blood collection (not including basal cell or squamous cell skin cancers).
  • Patient has undergone prior radiation therapy in the 5 years prior to blood collection.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to blood collection.

Inclusion Criteria
•Case Urine:

Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).

  • Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.
  • Age ≥ 18 years

Exclusion Criteria
•Case Urine:

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
  • Patient has recurrent bladder cancer.
  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
  • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
  • Patient has had any prior radiation therapy to the target lesion prior to current collection.
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
  • Patient has undergone cystectomy.
  • Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
  • Patient a has chronic indwelling urinary catheter.
  • Patient has had a urinary tract infection within the 14 days prior to sample collection.

Inclusion Criteria
•Disease Control Urine:

  • Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
  • Age ≥ 18 years.                                                 

Exclusion Criteria
•Disease Control Urine:

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
  • Patient has recurrent bladder cancer.
  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
  • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
  • Patient has had any prior radiation therapy to the target lesion prior to current collection.
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
  • Patient has undergone cystectomy.
  • Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
  • Patient a has chronic indwelling urinary catheter.
  • Patient has had a urinary tract infection within the 14 days prior to sample collection.

Inclusion Criteria
•Healthy Control Urine:

  • Age ≥ 18 years.                                                  

Exclusion Criteria
•Healthy Control Urine:

  • Patient has had a past or current diagnosis of invasive cancer  (this does not include basal or squamous skin cancers).
  • Patient has had a solid organ transplant.
  • Patient has chronic indwelling urinary catheter.
  • Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to sample collection.
  • Patient has had a urinary tract infection within 14 days prior to urine collection.

Inclusion Criteria - Case Blood:

Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).

  • Patient has a histological diagnosis of invasive urothelial cell carcinoma of bladder..
  • Age ≥ 18 years.

Exclusion Criteria
•Case Blood:

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
  • Patient has recurrent bladder cancer.
  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
  • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
  • Patient has had any prior radiation therapy to the target lesion prior to current collection.
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
  • Patient has undergone cystectomy.

Inclusion Criteria
•Disease Control Blood (Case patients with non-muscle invasive bladder cancer):

  • Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
  • Age ≥ 18 years.                                     

Exclusion Criteria - Disease Control Blood (Case patients with non-muscle invasive bladder cancer):

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
  • Patient has recurrent bladder cancer.
  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
  • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
  • Patient has had any prior radiation therapy to the target lesion prior to current collection.
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
  • Patient has undergone cystectomy.

Inclusion Criteria
•Healthy Control Blood:

  • Age ≥ 18 years.                                            

Exclusion Criteria
•Healthy Control Blood:

  • Patient has had a past or current diagnosis of  invasive cancer  (this does not include basal or squamous skin cancers).
  • Patient has had a solid organ transplant.

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

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Trigeminal Evoked Responses to Improve Rhizotomy

All
18 Years and over
Early Phase 1
This study is also accepting healthy volunteers
NCT05738096
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Inclusion Criteria:

• Adults of 18 years or older
• Scheduled to undergo percutaneous rhizotomy for facial pain
Exclusion Criteria:

• For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled
• For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
Other: TSEP + rhizotomy surgery, Other: TSEPs recording only
Trigeminal Neuralgia, Rhizotomy
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University of Minnesota — Minneapolis, Minnesota Danielle Carlson, MD - (carl1492@umn.edu)

Cognitive and Affective Processes Online

All
18 Years and over
This study is also accepting healthy volunteers
NCT05736471
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Inclusion Criteria:

• Adults 18 years or older
• English-speaking
• Live in the U.S.
• Have access to an internet connected computer
• Users of the mTurk and Prolific survey website
Exclusion Criteria:

• NA
Diagnostic Test: Computational dissociation of the causes of cognitive rigidity in depression
Depression
Cognitive rigidity, Foraging, Exploration-Exploitation
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Location Contacts
University of Minnesota — Minneapolis, Minnesota Matthew Maple - (maple036@umn.edu)

COVID-19 Emergency Preparedness and Risk Communication Among African-American Churches: Leveraging a Community-Based Participatory Research Partnership

COVID-19 Emergency Preparedness and Risk Communication Among African-American Churches: Leveraging a Community-Based Participatory Research Partnership

LaPrincess Brewer
All
18 years and over
This study is NOT accepting healthy volunteers
2020-303118-H01-RST
21-000182
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Inclusion Criteria:

  • Adult partipicipants, ≥ 18 years of age.
  • Participants from the partnering African-American (AA) churches.


Exclusion Criteria:

  • Individuals less than 18 years of age.
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Mayo Clinic — Rochester, MN

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy (Vedo CD)

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Michael Stephens
All
2 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-303973-P01-RST
21-002376
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Inclusion Criteria:

  • Subjects male or female aged 2 to 17 years, inclusive, who weigh ≥ 10 kg at the time of screening and enrollment into the study.
  • Subjects with moderately to severely active CD diagnosed at least 1 month before screening, defined by a PCDAI > 30 and an SES-CD > 6 (or an SES-CD ≥ 4 if disease is confined to terminal ileum).
  • Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents:
    • corticosteroids, immunomodulators (eg, AZA, 6-mercaptopurine, methotrexate), and/or TNF-α antagonist therapy (e.g., infliximab, adalimumab). This includes subjects who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
  • Subjects with extensive colitis or pancolitis of > 8 years’ duration or left-sided colitis of > 12 years’ duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
  • Subjects with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.


Exclusion Criteria:

  • Subjects who have had previous exposure to approved or investigational anti-integrins, including but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
  • Subjects who have had prior exposure to vedolizumab.
  • Subjects with hypersensitivity or allergies to any of the vedolizumab excipients.
  • Subjects who have received either:
    • an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or
    • an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
  • Subjects with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
  • Subjects who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
  • Subjects who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or > 3 small intestine resections.
  • Subjects with a current diagnosis of indeterminate colitis.
  • Subjects with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
Drug
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Mayo Clinic — Rochester, MN