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3292 Study Matches

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Telenephrology Consult Service as a Novel Method of Healthcare Delivery in the Mayo Clinic Health System (TM)

Telenephrology Within Mayo Clinic Health System

Robert Albright
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2021-303631-H01-MAIJ
20-000698
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Inclusion Criteria
•Patients:

  • Patient of Mayo Clinic, Dialysis Units.
  • 18 years of age or over.
  • Not pregnant.
  • Patient in MCHS.

Exclusion Criteria
•Patients:

  • Patients of FLA or ARZ Dialysis Unit.

Inclusion Criteria
•Providers:

  • Mayo Clinic employee.
  • Involved in Telenephrology.
  • Inpatient telenephrology consults.
  • Within MCHS and RST.

Exclusion Criteria
•Providers:

  • Providers in ARZ or FLA.
  • Non-Mayo Clinic providers.
  • Providers not involved in telenephrology.

 

 

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Mayo Clinic Health System — Mankato, MN

S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients With Germline BRCA1 or BRCA2 Mutations (S2001)

A Study to Test Adding Pembrolizumab to Olaparib Alone as Therapy for Patients with Pancreatic Cancer That Has Spread with Inherited BRCA Mutations

Robert McWilliams
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-303646-P01-RST
21-002016
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Inclusion Criteria:

  • Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
  • Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a Clinical Laboratory Improvement Act (CLIA) certified lab defined as positive and/or deleterious; that is, pathogenic or likely pathogenic variant.
    • NOTE: Patients with tumor somatic mutations are not eligible.
  • Patient must have metastatic disease and received first line platinum-based chemotherapy (i.e., fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX], leucovorin calcium, 5-fluorouracil, and oxaliplatin [FOLFOX], or gemcitabine + cisplatin.
  • Patients must have had a computed tomography (CT) or magnetic resonance imaging (MRI) showing stable or responding disease on first line platinum-based chemotherapy within 30 days prior to registration.
  • Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration.
  • Patients with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 30 days prior to registration.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 30 days prior to registration.
  • Patients must have received at least 16 weeks but no more than 24 weeks of first line platinum-based therapy for metastatic disease.
  • Patients' last chemotherapy treatment must be within 30 days prior to registration.
  • Patients must have resolved or stable ≤ grade 1 toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment, excluding neuropathy and alopecia.
  • Zubrod performance status of 0-1.
  • Patients must have a complete medical history and physical exam within 28 days prior to registration:
    • Absolute neutrophil count ≥ 1,500/mcL (within 14 days of registration);
    • Platelets ≥ 100,000/mcL (within 14 days of registration);
    • Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) (within 14 days of registration);
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 14 days of registration);
    • Creatinine ≤ 1.5 mg/dl (within 14 days of registration);
    • Albumin ≥ 3.0 (within 14 days of registration);
    • Hemoglobin ≥ 9.0 g/dL.
  • Patients must have CA19-9 obtained within 42 days prior to registration.
  • Patients must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial provided it does not require concurrent therapy.
  • Patients must be offered the opportunity to participate in specimen banking of formalin-fixed paraffin-embedded (FFPE) tissue and whole blood. If a patient is unable to submit archival tissue, should the patient need to undergo a standard of care biopsy per National Comprehensive Cancer Network (NCCN) guidelines, patients must then be offered the opportunity to submit the fresh tumor tissue from that biopsy. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
  • Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Canada Industrial Relations Board (CIRB) regulations.
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.


Exclusion Criteria:

  • Patients must not have a known hypersensitivity to olaparib or any of the excipients of the product.
  • Patients must not be planning to receive strong or moderate CYP3A inhibitors or inducers while on olaparib treatment.
  • Patients receiving strong or moderate CYP3A inhibitors must discontinue use at least 2 weeks prior to receiving olaparib.
  • Patients receiving strong or moderate CYP3A inducers must discontinue use at least 5 weeks prior to receiving olaparib. Medications should be checked using a frequently updated medical reference for a list of drugs to avoid.
  • Patients must not have received live vaccines within 42 days prior to randomization and must not be planning to receive live virus or live bacterial vaccines while receiving study treatment and during the 30 day follow up period. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.
  • Patients must not have had prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immune checkpoint inhibitors.
  • Patients must not have had prior therapy with PARP inhibitors.
  • Patients must not have had a prior diagnosis of immunodeficiency or receiving systemic steroid therapy (defined as ≥ 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Participants must not be pregnant or nursing due to the possibility of harm to the fetus or nursing infant from this treatment regimen. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 6 months after the last dose of study medication. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Patients must not have an active infection requiring systemic therapy.
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Drug, Biologic/Vaccine
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Mayo Clinic — Rochester, MN

S2007, A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases

A Study to Test Sacituzumab Govitecan Therapy in Patients with HER2-Negative Breast Cancer and Brain Metastases

Roberto Leon Ferre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-303648-P01-RST
21-002283
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Inclusion Criteria:

  • Participants must have histologically confirmed HER2-negative (per 2018 American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] joint guideline) invasive breast cancer that has metastasized to the brain.
    • NOTE: Pathology report must confirm HER2-negative invasive breast cancer. Brain metastases must be confirmed by radiology report.
  • Participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy (in the opinion of the treating physician). In the rare case that a previously irradiated brain metastasis is the sole target lesion and if there is concern about possible radiation necrosis, patient is eligible only if there is clear progression in the previously radiated lesion. Computed tomography (CT) of the head cannot substitute for brain MRI. All central nervous system (CNS) disease must be assessed and documented on the S2007 Brain Metastases Baseline Tumor Assessment Form
  • Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration. Participants are NOT required to have extracranial disease, but must have scans done to document disease status at baseline. All extracranial disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
    • NOTE: Brain lesions should not be included on the Baseline Tumor Assessment Form (RECIST 1.1) for this study.
  • Participants must have had CNS progression after previous CNS-directed therapy (radiation therapy, surgery, or any combination of therapy)
  • Participants must have resolution of adverse event(s) of the most recent prior systemic anti-cancer therapy to < grade 2, with the exception of alopecia and =< grade 2 neuropathy, which are allowed
  • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Participants must have Zubrod performance status 0 or 1
  • Participants must have history and physical exam obtained within 21 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1,500/mcL (obtained within 21 days prior to registration);
    • Platelet count ≥ 100,000/mcL (obtained within 21 days prior to registration);
    • Hemoglobin ≥ 9.0 g/dL (obtained within 21 days prior to registration);
    • Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN) (obtained within 21 days prior to registration);
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x institutional ULN (obtained within 21 days prior to registration);
    • Participants must have a serum creatinine ≤ 1.5 times the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 21 days prior to registration.
  • Participants must have adequate cardiac function.
  • Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification, and must be class 2B or better
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.


Exclusion Criteria:

  • Participants must not have had more than 2 seizures within 28 days prior to registration.
  • Participants must not have received systemic therapy (including small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 7 days prior to registration.
  • Participants must not have received anti-cancer biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to registration.
  • Participants must not have received nitrosoureas or mitomycin C within 42 days, metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days prior to registration -Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral agents that are strong CYP3A4 inhibitors or inducers and who are unwilling or unable to change to antiretroviral therapies without such interactions are ineligible because of the potential for pharmacokinetic interactions with sacituzumab govitecan (IMMU-132).
  • Due to potential drug interactions of anti-retroviral drugs with sacituzumab govitecan (IMMU-132), participants must not have known active or chronic hepatitis B virus (HBV) infection, requiring suppressive therapy or known active hepatitis C virus (HCV) infection. Participants with a known history of HCV infection must have been treated and cured -Participants must not have received enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) within 7 days prior to registration or within 14 days of planned start of cycle 1, day 1 treatment, and participants must not be planning to receive enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) for the duration of protocol treatment.
  • Participants must not be receiving warfarin (or other coumarin derivatives) at time of registration or be planning to receive warfarin (or other coumarin derivatives) for the duration of protocol treatment.
  • Participants who are able to switch to low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) prior to date of registration (and plan to remain off of warfarin or other coumarin derivatives) for the duration of protocol treatment) are eligible.
  • Patients must not be receiving or be planning to receive concomitantly any other anti-cancer therapy, including endocrine therapy.
    • NOTE: Concomitant hormone replacement therapy is allowed.
  • Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (> 4 mg daily dexamethasone [or bioequivalent]) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.
  • Participants must not have uncontrolled diabetes in the opinion of the treating investigator 21 days prior to registration.
  • Participants must not be pregnant or nursing. Women of reproductive potential must have a negative serum or urine pregnancy test within 7 days prior to registration. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the duration of protocol treatment and for at least 6 months after the last dose of sacituzumab govitecan (IMMU-132). A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined, he/she is responsible for beginning contraceptive measures.
Biologic/Vaccine
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Mayo Clinic — Rochester, MN

RPL-001-16: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors (IGNYTE)

A Study to Evaluate RP1 Monotherapy and Combined with Nivolumab

Robert McWilliams
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-303656-P01-RST
21-001475
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Inclusion Criteria:


- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

- At least one measurable and injectable lesion

- Have provided a former tumor pathology specimen or be willing to supply a new tumor
sample from a biopsy

- Have a predicted life expectancy of ≥ 3 months

- Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1 criteria

- Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor
(according to protocol definition) for whom anti PD-1 therapy is indicated, or have
refused, become intolerant to or have no further therapy options available

- Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not
considered treatable by surgery including basal cell carcinoma, cutaneous squamous
cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma
skin cancers (per protocol) for whom anti-PD1/PD-L1 therapy is indicated, or have
refused, become intolerant to or have no further therapy options available

- Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease
while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status

- Subjects with anti-PD1 failed NSCLC: has confirmed progressive disease after no more
than two prior systemic treatments including anti-PD1/PD-L1 treatment


Exclusion Criteria:


- Prior treatment with an oncolytic therapy

- History of viral infections according to the protocol

- Prior complications with herpes infections

- Chronic use of anti-virals

- Uncontrolled/untreated brain metastasis

- History of interstitial lung disease

- History of non-infectious pneumonitis

- History of clinically significant cardiovascular disease

Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Oncolytic viral therapy, Oncolytic virus therapy
Basal cell carcinoma, Cancer, Lung cancer, Melanoma, Merkel cell carcinoma, Non-melanoma skin cancer, Non-small cell lung cancer, Skin cancer, Squamous cell carcinoma of the skin
Basosquamous carcinoma of skin, Biological therapy for cancer, Cancer treatment, Integumentary system, MDX-1106, Malignant melanoma of skin, Malignant melanoma with BRAF V600E mutation, Medical Oncology, Merkel cell carcinoma, Metastatic basal cell carcinoma, Non-small cell lung cancer, Respiratory system, Secondary squamous cell carcinoma of skin, Solid tumor configuration, Virotherapy, nivolumab
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Mayo Clinic — Rochester, MN

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (RIN-PF-301)

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Teng Moua
All
40 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-303662-P01-RST
21-002667
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Inclusion Criteria:


1. Subject gives voluntary informed consent to participate in the study.

2. Subject is ≥ 40 years of age, inclusive, at the time of signing informed consent.

3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical
Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution
computed tomography (HRCT) (performed within the previous 12 months), and if
available, surgical lung biopsy.

4. FVC ≥ 45% predicted at Screening.

5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30
days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not
permitted.

6. Women of childbearing potential must be non-pregnant (as confirmed by a urine
pregnancy test at Screening and Baseline) and non-lactating, and will abstain from
intercourse (when it is in line with their preferred and usual lifestyle) or use 2
medically acceptable, highly effective forms of contraception for the duration of the
study, and at least 30 days after discontinuing study drug.

7. Males with a partner of childbearing potential must use a condom for the duration of
treatment and for at least 48 hours after discontinuing study drug.

8. In the opinion of the Investigator, the subject is able to communicate effectively
with study personnel, and is considered reliable, willing, and likely to be
cooperative with protocol requirements, including attending all study visits.


Exclusion Criteria:


1. Subject is pregnant or lactating.

2. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.

3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or
prostacyclin analogue that resulted in discontinuation or inability to effectively
titrate that therapy.

4. The subject has received any PAH-approved therapy, including prostacyclin therapy
(epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity
testing), IP receptor agonists (selexipag), endothelin receptor antagonists,
phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase
stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile
dysfunction is permitted, provided no doses are taken within 48 hours of any
study-related efficacy assessments.

5. Use of any of the following medications: azathioprine (AZA), cyclosporine,
mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the
combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline;
cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior
to Baseline.

6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery
at rest at Baseline.

7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days
prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for
treatment of the infection or acute exacerbation more than 30 days prior to Baseline
to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or
upper respiratory infection, subjects must have been discharged more than 90 days
prior to Baseline to be eligible.

8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior
to Baseline or unstable angina within 30 days prior to Baseline.

9. In the opinion of the Investigator, the subject has any condition that would interfere
with the interpretation of study assessments or would impair study participation or
cooperation.

10. Use of any other investigational drug/device or participation in any investigational
study in which the subject received a medical intervention (ie, procedure, device,
medication/supplement) within 30 days prior to Screening. Subjects participating in
non-interventional, observational, or registry studies are eligible.

11. Life expectancy <6 months due to IPF or a concomitant illness.

12. Acute pulmonary embolism within 90 days prior to Baseline.

Device, Drug
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Mayo Clinic — Rochester, MN

A Phase 1/2, dose escalation and expansion study of the safety, tolerability, and anti-tumor activity of BND-22 administered alone and in combination with pembrolizumab or with cetuximab in patients with advanced solid tumors

An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of BND-22 in Patients with Advanced Solid Tumors

Zhaohui Jin
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-303665-P01-RST
21-001327
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Inclusion Criteria:


- Patients with unresectable or metastatic disease who are refractory to or are not
candidates for standard approved therapy

- Histologic confirmation of malignancy

- Measurable disease per RECIST v1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1

- Participants must have adequate organ function as defined by lab tests

- Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer,
adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or
gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and
neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer,
cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell
carcinoma of the skin, or urothelial carcinoma

- Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric
or gastroesophageal junction adenocarcinoma, Non-small cell lung cancer


Exclusion Criteria:


- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications

- Brain or leptomeningeal metastases

- Known history of positive test for HIV

- Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV);
HCC patients: untreated active HBV or dual infection with HBV/HCV

- Participants after solid organ or allogeneic hematopoietic stem cell transplant

- History of life-threatening toxicity related to prior immune therapy

- History of life-threatening toxicity related to prior cetuximab or other anti-EGFR
antibodies (for Sub-Part 1C)

- Unstable or deteriorating cardiovascular disease within the previous 6 months

- Any major surgery within 4 weeks of study drug administration

- Prior/Concomitant Therapy:

- Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from
last dose

- Use of other investigational drugs within 28 days

- Prior treatment with macrophage or natural killer (NK) cells activating therapies

- Administration of a live attenuated vaccine within 28 days

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

Eligibility last updated 11/9/22. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

MC210901: A Mixed Method Approach to Explore Successful Recruitment and Treatment of Minority Patients on Therapeutic Cancer Clinical Trials at Mayo Clinic (MC210901)

Recruitment/Treatment of Minority Patients on Cancer Trials at Mayo Clinic

Katharine Price
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303666-H01-RST
21-001328
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Inclusion Criteria

  • Under-represented minority (Black/African American, Native Hawaiian/Pacific Islander, Native American/Alaska native, more than 1 race, and Hispanic/LatinX).
  • Received cancer care on an interventional treatment clinical trial at Mayo Clinic (enterprise-wide) between 2018-2020. 
  • Consent to participate (for the survey and interview components).


Exclusion Criteria:

  • No specific exclusion criteria. 
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Mayo Clinic — Rochester, MN

Communities During COVID - Key Informants

A Study to Evaluate Key Impacts on Communities During COVID

Sean Phelan
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303667-H01-RST
21-001802
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Inclusion Criteria:

  • Adults, ≥ 18 years of age.
  • Member of the community in a leadership or representative position.


Exclusion Criteria:
 

  • Individuals 18 years of age.
Coronavirus disease 2019, General infectious diseases
COVID-19, Community resource finding, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Ineffective community coping, Lack of psychological resilience, Psychological resilience, Ready for enhanced community coping, Resilience training, Respiratory system
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Mayo Clinic — Rochester, MN

XL184-315, A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer (CONTACT-02)

Study of Cabozantinib Combined With Atezolizumab Vs. Second Novel Hormonal Therapy in Subjects with Metastatic Castration-Resistant Prostate Cancer

Lance Pagliaro
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-303671-P01-RST
21-001334
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Inclusion Criteria:


- Men with histologically or cytologically confirmed adenocarcinoma of the prostate

- Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide,
darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or
mCSPC, M0 CRPC, or mCRPC

- Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at
screening

- Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment
defined by at least one of the following: measurable visceral disease (eg, adrenal,
kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic
adenopathy (ie, adenopathy above the aortic bifurcation)

- Progressive disease at study entry as defined by specific criteria for prostate
specific antigen (PSA) progression OR soft tissue disease progression in the opinion
of the Investigator (Note: subjects with bone disease progression alone are not
eligible)

- Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the
day of consent

- ECOG performance status of 0 or 1

- Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events
(CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are
clinically nonsignificant and/or stable on supportive therapy in the opinion of the
Investigator

- Adequate organ and marrow function based upon specific laboratory assessments obtained
within 21 days prior to randomization

- Understanding and ability to comply with protocol requirements


Exclusion Criteria:


- Any prior nonhormonal therapy initiated for the treatment of mCRPC

- Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide,
nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2
weeks before randomization

- Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization
(subjects with clinically relevant ongoing complications from prior radiation therapy
are not eligible)

- Known brain metastases or cranial epidural disease unless adequately treated and
clinically stable at least 4 weeks prior to randomization

- Symptomatic or impending spinal cord compression or cauda equina syndrome

- Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)

- Administration of a live, attenuated vaccine within 30 days prior to randomization

- Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg
daily prednisone equivalent) or other immunosuppressive medications within 14 days
prior to randomization

- Uncontrolled, significant intercurrent or recent illness

- Major surgery within 4 weeks prior to randomization

- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG
within 21 days before randomization

- Inability or unwillingness to swallow pills or receive IV administration

- Previously identified allergy or hypersensitivity to components of the study treatment
formulations or history of severe infusion-related reactions to monoclonal antibodies

- Any other active malignancy at time of randomization or diagnosis of another
malignancy within 2 years prior to randomization that requires active treatment (some
exceptions apply such as locally curable cancers that have apparently been cured).

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

Eligibility last updated 10/13/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Discovering Digital Biomarkers Linked to Opioid Use Disorder

A Study to Evaluate Digital Biomarkers Linked to Opioid Use Disorder

Tyler Oesterle
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303682-H01-RST
21-001383
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Inclusion Criteria:

  • Diagnosed with Opioid Use Disorder (OUD).
  • Willing to participate and follow medication-assisted treatment (MAT) program rules.
  • Willing to wear a watch and answer questionnaires.


Exclusion Criteria:
 

  • Active untreated comorbid mental health symptoms.
  • Unable to understand or sign informed consent.
  • History of heart disease.
  • Women currently pregnant.
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Bone Health in Patients With and Without Adrenal Disease

Bone Health in Patients with/without Adrenal Disease

Irina Bancos
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303683-H01-RST
21-001396
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Inclusion Criteria:

  • Adult ≥ 18 years old.
  • Diagnosis of either of the following conditions:
    • adrenal adenoma;
    • macro- or micronodular hyperplasia with available or planned dexamethasone suppression test result;
    • ACTH-dependent Cushing syndrome;
    • No adrenal disorder (as referent subject).
  • Ability to provide consent.


Exclusion Criteria:
 

  • Individual < 18 years of age.
  • Inability to provide consent.
  • Exogenous Cushing syndrome,

Eligibility last updated 3/10/22. Questions regarding updates should be directed to the study team contact.

Adrenal cancer, Cushing syndrome, Fracture, Osteoporosis, Osteopenia
Endocrine system, Fracture of bone, Macronodular adrenal hyperplasia, Micronodular adrenal hyperplasia, Musculoskeletal system, Osteopenia, Adrenal adenoma, Osteoporosis
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Biomarker guided Electroconvulsive therapy for Superior Treatment outcomes in patients with mood disorders (BEST-Mood)

A Study to Evaluate Garmin Wearables for Patients Receiving Electroconvulsive Therapy

Paul Croarkin
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303688-H01-RST
21-001413
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Inclusion Criteria:

  • Aged 18 years or older.
  • Outpatient or inpatient status.
  • Patients who have been clinically referred for ECT and completed the clinical informed consent process for ECT.
  • Patients who had the capacity to consent for ECT independently on a voluntary basis.
  • Healthy control patients will be aged 18 years or older and have the capacity to consent for the research study.


Exclusion Criteria:
 

  • Patients who are undergoing court ordered ECT are not eligible for the study.
  • Patients who did not have the capacity to consent for clinical ECT are not eligible.
  • Patients who in the opinion of the clinical principal investigator (Dr. Croarkin) or a psychiatrist study team member are not able to consistently wear the Garmin device or complete protocol related activities.
  • Healthy control patients who have active psychiatric symptoms based on an interview with the principal investigator (Dr. Croarkin) or a psychiatrist study team member are not eligible to participate. 
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A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD (CSP-00006)

A Study to Evaluate RheOx Bronchial Rheoplasty System to Treat Chronic Bronchitis in Adults with COPD

Ryan Kern
All
35 years and over
Not Applicable, Early Feasibility
This study is NOT accepting healthy volunteers
2021-303692-P01-RST
21-002659
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Inclusion Criteria:


1. Patient is at least 35 years of age.

2. Patient has chronic bronchitis, defined as productive cough for three months in each
of two successive years, whereas other causes of productive cough have been ruled out.

3. Patient has a CAT score ≥ 10.

4. Patient has an SGRQ score ≥ 25.

5. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points
or the sum is 6 points and the patient's total CAT score is > 20 points.

6. Patient has FEV1/FVC < 0.7.

7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.

8. Patient is receiving guideline directed pharmacotherapy which includes one or more
long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for
at least 8 weeks prior to randomization

9. Patient has a cigarette smoking history of at least ten pack years.

10. In the opinion of the Primary investigator, patient is able to undergo 2
bronchoscopies under general anesthesia and is able to adhere to the study follow-up
schedule


Exclusion Criteria:


1. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia,
mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).

2. Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per
day.

3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter
defibrillator, neuro-stimulation devices).

4. Patient has a history of arrhythmia within past two years which includes tachy-atrial
arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate
less than 45 beats per minute.

5. Patient has unresolved lung cancer.

6. Patient has a pulmonary nodule or cavity that in the judgement of the Primary
investigator may require intervention during the course of the study.

7. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung
implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior
pneumothorax without lung resection, pleural procedures without surgery, or
segmentectomy are acceptable.

8. Patient has emphysema of greater than or equal to 20% as quantified on baseline HRCT
scan (low attenuation area less than -950HU) as determined by the CT Core Lab.

9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.

10. Patient has clinically significant bronchiectasis influencing the patient's clinical
symptoms of cough and phlegm.

11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.)
within the last 6 months.

12. Patient is unable to walk over 225 meters in 6 minutes.

13. Patient has a serious medical condition that, in the Primary investigator's opinion,
could compromise patient safety or confound the interpretation of the patient's
response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial
infarction in the past year, renal failure, liver disease cerebrovascular accident
within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension
(diastolic BP >100mmHg) or autoimmune disease requiring treatment with
immunosuppressant medications or a disease requiring chemotherapy).

14. Patient has uncontrolled GERD.

15. Patient has known severe pulmonary hypertension.

16. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e.,
lidocaine, atropine, benzodiazepines).

17. Patient is pregnant, nursing, or planning to get pregnant during study duration.

18. Patient is currently participating in another clinical study involving an
investigational product

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

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

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Quality of Life Outcomes After Subtotal Petrosectomy and Ear Canal Closure for Cholesteatoma: A Retrospective Study (ECC)

A Study to Evaluate Quality of Life Outcomes for Cholesteatoma

Matthew Carlson
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303721-H01-RST
21-001587
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Inclusion Criteria:

  • Adults, ≥ 18 years of age.
  • Have undergone subtotal petrosectomy and ear canal closure with or without bone conduction hearing aid implantation for cholesteatoma/chronic otitis media since 1/1/2020.


Exclusion Criteria:
 

  • Individuals < 18 years of age.
  • Subtotal petrosectomy and ear canal closure for other diagnoses, surgical intervention before 1/1/2000.
  • Patients who do not desire to complete the survey.
  • Patients who do not sign the study’s HIPAA Authorization form.
     
Cholesteatoma, Middle ear disease, Middle ear infection
Cholesteatoma, Chronic otitis media, Hearing implant surgery
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The Predictive Capabilities of Exhaled Volatile Organic Compounds (VOCs) on Heart Failure Status: A Pilot Study (HFVOC)

Exhaled Biomarkers for Heart Failure

Bruce Johnson
All
21 years and over
This study is NOT accepting healthy volunteers
2021-303723-H01-RST
21-001574
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Inclusion Criteria:

  • Adults over the age of 21 and who are willing and able to give informed consent.
  • Diagnosed with CHF and presenting to Mayo Clinic for HF clinic visits.
  • Classified as NYHA Class I-IV within the past 12 months.


Exclusion Criteria:
 

  • Under the age of 21.
  • Physical or cognitive limitations that would prevent patient from applying or using the device properly.
  • Women who are known to be pregnant or plan to become pregnant within the course of this study.
  • Has known allergies to silicone based adhesive or skin breakdown in areas where device placement is required.
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Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Nicholas Chia
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303747-H01-RST
21-001536
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Inclusion Criteria:

  • 18 years of age or older.
  • Patients undergoing bowel resection by any standard surgical approach.


Exclusion Criteria:

  • Female who is pregnant.
  • Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.
  • Currently receiving or have received chemotherapy in the past 2 weeks.
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An Open-Label Extension Study for Patients with Dravet Syndrome Who Previously Participated in Studies of STK-001 (Swallowtail)

A Study to Evaluate Patients with Dravet Syndrome Who Previously Participated in Studies of STK-001

Elaine Wirrell
All
30 months and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-303748-P01-RST
21-001955
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Inclusion Criteria:

  • Patient must be ≥ 2.5 years of age.
  • Patient and/or authorized representative must be willing and able to give informed consent/assent and any authorizations required by local law for participation in the study.
  • Patient and their caregiver must be willing and able (in the Investigator’s opinion) to comply with all protocol requirements.
  • Patient must have completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101, with an acceptable safety profile per Investigator judgment.
  • Patient must have satisfactory compliance with study visits and procedures in Study STK-001-DS-101 per Investigator and Sponsor judgment.
  • Patient must meet age-appropriate institutional standard practices for intrathecal (IT) drug administration procedures.
  • Patient and/or family (or caretaker) must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
  • Patient must have completed Study STK-001-DS-101 within 4 weeks of the start of their participation in Study STK-001-DS-501, unless approved by the Sponsor.


Exclusion Criteria:

  • Patient has met any withdrawal criteria from Study STK-001-DS-101.
  • Patient is currently being treated as maintenance therapy with an antiepileptic drug acting primarily as a sodium channel blocker including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.
  • Patient has clinically significant unstable medical conditions other than epilepsy.
  • Patient has had clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) at Screening or prior to dosing on Day 1, other than epilepsy.
  • Patient has a spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt.
  • Patient has clinically significant (in the judgment of the Investigator) abnormal laboratory values at baseline or prior to dosing on Day 1.
  • Patient has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3-fold upper limit of normal (ULN), serum creatinine > ULN or platelet count < lower limit of normal at baseline and upon repeat testing.
  • Patient has clinically significant abnormalities (in the judgment of the Investigator) in the 12-lead ECG measured at Screening/Baseline (This includes 12-lead ECG from STK-001-DS-101 [Visit 6 or Visit 9], if STK-001-DS-101 Visit 6 or Visit 9 and STK-001-DS-501 Visit 1 are the Same Day).
  • Patient has a psychiatric or behavioral disorder which, in the opinion of the Investigator, may interfere with the patient’s participation in the study.
  • Patient is currently taking, or within 4 weeks prior to Screening/Baseline has taken any anticoagulant (including but not limited to heparins, warfarin and other vitamin K antagonists, dabigatran, rivaroxaban and apixaban), or within 7 days prior to Screening/Baseline, has taken any antiplatelet (including but not limited to aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, ticlopidine. and dipyridamole).
  • Patient is a female of childbearing potential, or patient is a fertile male with female partner(s) of childbearing potential, unless willing to ensure that they or their partners use effective contraception throughout the duration of the study and for at least 6 months after their last dose of STK-001.
  • . Patient is a female who is lactating or planning pregnancy during the duration of the study and for at least 6 months after their last dose of STK-001.
  • Patient has any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, may influence the results of the study, or may affect the patient’s ability to participate in the study.
  • Patient has been treated (or is being treated) with an investigational product (other than STK-001) since participating in Study STK-001-DS-101.
  • Patient is participating in an observational study, unless approved by the Sponsor.
Drug, Drug therapy, Intrathecal injection
Epilepsy, Seizure
Nervous system, Severe myoclonic epilepsy in infancy
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Minnesota Spinal Cord Injury Data Network

Minnesota Spinal Cord Injury Data Network

Kristin Zhao
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303749-H01-RST
21-001639
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
  • Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
  • Admission to the database within one year of injury.
  • If patient is discharged as Minimal Deficit or Recovered, they must be hospitalized in the system for at least one week before discharge.
  • Discharge from the system as:
    • Having completed inpatient acute rehabilitation;
    • Achieving a neurologic status of normal or minimal deficit;
    • Deceased.
  • Reside in the geographic catchment area of the system (greater Minnesota, Iowa, North Dakota, South Dakota, and western Wisconsin) at the time of the injury. Patients may be injured outside of the catchment area.
  • A US citizen or non-US citizen who is expected to stay in the catchment area.


Exclusion Criteria:
 

  • Completion of an organized rehabilitation program prior to the admission to the system.
  • Patients who are discharged as deceased.
Spinal cord injury
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The Application of Voice Enabled Artificial Intelligence for the Diagnosis of Hepatic Encephalopathy (Voice AI)

A Study to Evaluate Voice-enabled Artificial Intelligence to Diagnosis Hepatic Encephalopathy

Douglas Simonetto
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303761-H01-RST
21-001699
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Inclusion Criteria:

  • Male or female, age ≥ 18 years old.
  • Having hepatic encephalopathy (HE).
  • Are in the hospital (Methodist or St. Marys). Consented in an exam room or hospital room
  • Must be able to carry on a conversation.
  • Ability of subject or caregiver to provide written, informed consent. (LAR needed if subject is HE)
  • Cirrhosis of any etiology.


Exclusion Criteria:

  • Individual < 18 years old.
  • Known history of voice disorder or surgery that may alter voice characteristics.
  • Smoking or vaping use currently or within the last 3 months
  • Severe chronic obstructive pulmonary disease
  • Inability to speak.
  • Upper respiratory tract infection within the last week.
  • Acute alcohol intoxication.
  • VHI-10 score greater than 11.
  • West Haven Criteria Grade 4.
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Impact of Ketamine versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery (KKICS)

Ketamine and Kidney Injury in Cardiac Surgery

Erica Wittwer
All
70 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-303772-H01-RST
21-004327
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Inclusion Criteria:

  • Age greater than or equal to 70 years.
  • Presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota. 
  • Scheduled to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.


Exclusion Criteria:

  • Left or right ventricular assist device implantation or explantation.
  • Procedures not requiring cardiopulmonary bypass.
  • Active infection or sepsis.
  • Severe hepatic disease or ascites.
  • Pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis.
  • Immunosuppressive medication use (including steroid use), immunodeficiency syndrome, known neurologic or psychiatric disorder, or use of drugs for psychosis.

 

 

 

We will include patients age greater than or equal to 70 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.  Patients will be eligible for inclusion if they are schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures. Exclusion criteria will include left or right ventricular assist device implantation or explantation, procedures not requiring cardiopulmonary bypass, active infection or sepsis, severe hepatic disease or ascites, pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis, immunosuppressive medication use (including steroid use), immunodeficiency syndrome, known neurologic or psychiatric disorder, or use of drugs for psychosis.

Drug
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AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery (CP2018-1)

AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

Juan Crestanello
All
18 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-303779-P01-RST
21-001790
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Inclusion Criteria:

  • Subject is greater than or equal to 18 years of age.
  • Subject has history of persistent or long-standing persistent atrial fibrillation:
    • AF documentation requirement for persistent AF: Physician’s note indicating continuous AF > 7 days but no more than 1 year, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure;
    • AF documentation requirement for longstanding persistent AF: physician’s note indicating at least 1 year of continuous AF, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure. The performance of a successful cardioversion (sinus rhythm > 30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as long-standing persistent.
  • Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, patent foramen ovale repair, and/or atrial septal defect.
  • Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
  • Subject is willing and able to provide written informed consent.
  • Subject has a life expectancy of at least 5-years.
  • Subject is willing and able to return for scheduled follow-up visits.


Exclusion Criteria:

  • Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
  • Previous surgical Maze procedure.
  • Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, AV nodal reentry.
  • Prior cardiac surgery (Redo).
  • Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
  • Class IV NYHA heart failure symptoms.
  • Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit.
  • Documented ST elevation MI within the 6 weeks prior to study enrollment.
  • Need for emergent cardiac surgery (i.e., cardiogenic shock).
  • Known carotid artery stenosis greater than 80%.
  • Documented (continuous) AF duration of greater than ten years.
  • LA diameter > 7 cm by TTE within 12 weeks (90 days) of procedure.
  • Current diagnosis of active systemic infection.
  • Severe peripheral arterial occlusive disease defined as claudication with minimal exertion.
  • Renal failure requiring dialysis or hepatic failure.
  • A known drug and/or alcohol addiction.
  • Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study.
  • Pregnancy or desire to get pregnant within 12-months of the study treatment.
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
  • Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia.
  • Subjects who have been treated with thoracic radiation.
  • Subjects in current chemotherapy.
  • Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
  • Subjects with known connective tissue disorders.
  • Subjects with known hypertrophic obstructive cardiomyopathy.
  • Subjects with known cold agglutinin.
  • Patient has a condition that in the opinion of the investigator, may jeopardize the patient’s wellbeing and/or the soundness of this clinical study.
  • Subject has a contraindication to post-operative anticoagulation; Patient has history of blood dyscrasia or clotting disorder (i.e., Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).

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

Device
Atrial fibrillation, Heart arrhythmia
Cardiovascular system, Longstanding persistent atrial fibrillation, Persistent atrial fibrillation
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Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant

A Study to Develop Novel Tools for Post-HCT Respiratory Complications

Hemang Yadav
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303794-P01-RST
21-000913
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Inclusion Criteria:

  • Adult patients (age ≥ 18 years old).
  • Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester.
  • Scheduled for pre-HCT pulmonary function test by the primary team.


Exclusion Criteria:
 

  • Limited mobility requiring use of gait aid or wheelchair.
  • Fall risk.

 

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Impact of Menopause on Cardiac Stiffness Acquired with Magnetic Resonance Elastography

A Study to Evaluate the Impact of Menopause on Cardiac Stiffness Acquired with Magnetic Resonance Elastography

Arvin Forghanian-Arani
All
21 years to 53 years old
This study is NOT accepting healthy volunteers
2021-303801-H01-RST
21-001823
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Inclusion Criteria:

Aim 1

  • Healthy, normal subjects around the approximate age of menopause (~ 51).
  • In the 40-60 year age range without known cardiac conditions.
  • Without symptoms referable to the heart, namely chest pain or shortness of breath. 

Aim 2

  • Subjects from the ongoing “Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy: A Randomized Controlled Trial” study.  
  • Subjects in this cohort will be between 21 and 45 years of age, at the onset of the study.
  • Willingness to return for follow up exam +/- 3 weeks of 12 month post-operative follow-up appointment.
  • These subjects will undergo two cardiac MRI/MRE exams one with-in +/- three weeks of their bilateral oophorectomy surgery and with-in +/- three weeks of their 12 month follow-up appointment.


Exclusion Criteria:
 

  • Known cardiac conditions, symptoms referable to the heart; namely, chest pain or shortness of breath. 
  • For Magnetic Resonance Imaging (MRI) participants:
    • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, deep brain stimulator, or severe claustrophobia;
    • Body weight over 500 pounds (or 226 kilograms), and chest/waist/hip circumference over 160 cm, due to MRI system limit (70-cm bore, < 400 lbs.).
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Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository- HS PROGRESS

Hidradenitis Suppurativa Registry

Afsaneh Alavi
All
10 years and over
This study is NOT accepting healthy volunteers
2021-303810-H01-RST
21-001797
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Inclusion Criteria:

  • Male or female, ≥ 10 years of age.
  • Diagnosis of Hidradenitis Suppurativa (HS) by a dermatologist or practitioner experienced in making a diagnosis of HS.
  • Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
  • Immediate family members (for saliva and genetics data).


Exclusion Criteria:

  • Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.
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Learning from Our Patients, Learning from Our Practice: Implementing an Intervention to Support Patients on Dialysis

Learning from Our Patients, Learning from Our Practice: Implementing an Intervention to Support Patients on Dialysis

Kasey Boehmer
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-303832-H01-RST
21-001884
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Inclusion Criteria:

Clinician Participants

  • Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic Department of Nephrology and Hypertension Dialysis Services.

Patient Participants

  • Adult patients (18 years of age and older).
  • Receive long-term dialysis treatment and services at Mayo Clinic.


Exclusion Criteria:

  • Minors (under the age of 18 years).
  • Non-English speaking.
  • Lack the ability to provide informed consent.
Other, Behavioral
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Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients with Inflammatory Bowel Disease: Phase II – The Impact (IBD and WHC II)

IBD and Women's Health Intervention

Laura Raffals
Female
18 years to 64 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-303837-H01-RST
21-002100
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Inclusion Criteria:

  • Female patient with a diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) seen in the IBD clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.
  • Who are between 18-64 years of age.
  • Ability to provide informed consent.
  • Ability to complete all aspects of this trial.


Exclusion Criteria:
 

  • Female patients with a diagnosis of UC or CD with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
  • Participation in another organized wellness program.
Behavioral
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A Comparative Quality of Life Assessment between Internal Endoscopic versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction (QoL)

A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage

Andrew Storm
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303842-H01-RST
21-000142
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Inclusion Criteria:

  • Patients with benign biliary obstruction.
  • Patients with malignant biliary obstruction.
  • Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous transhepatic biliary drainage (PTBD).


Exclusion Criteria:
 

  • Patients with gallstone disease.
  • Patients who will undergo ERCP who currently have a percuteanous biliary drain placed.
  • Patients who will undergo PTBD who currently have a biliary stent placed.
  • Female patients who are pregnant.
  • Prisoners and other vulnerable populations.

Eligibility last updated 10/12/21. Questions regarding updates should be directed to the study team contact.

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A Phase I Study of DS-8201a in Combination with Olaparib in HER2-Expressing Malignancies

A Study to Evaluate DS-8201a Combined with Olaparib in HER2-Expressing Cancers with Expansion in Endometrial Cancer Patients Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Endometrial Cancer

Andrea Wahner Hendrickson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-303850-P01-RST
21-001959
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Inclusion Criteria:

  • Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Patients must have histologically confirmed uterine serous carcinoma with at least one lesion suitable for biopsy without significant risk to the patient.  Patient disease must be evaluable or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Biopsiable lesion can be same as evaluable lesion.
  • Patients must have had at least one prior line of cytotoxic chemotherapy. Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy
  • Patients must have HER2-positive or HER2-expressing tumors determined by a CLIA-certified laboratory. Specific requirement of HER2 status is outlined below:
    • HER2 1-3 + expression by IHC; OR
    • HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH); OR
    • If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible.
  • Patients must have archival FFPE tissue available for central confirmation of HER2 testing.
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of DS-8201a in combination with olaparib in patients < 18 years of age, children are excluded from this study.
  • ECOG performance status ≤ 1 (Karnofsky ≥ 70%).
  • Patients must have adequate organ and marrow function within 14 days of randomization/enrollment as defined below:
    • Hemoglobin ≥ 10.0 g/dL;
    • Absolute neutrophil count ≥ 1,000/mcL**;
    • Platelets ≥ 100,000/mcL*;
    • Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (< 3 × ULN in the presence of documented Gilbert’s syndrome or liver metastases at baseline);
    • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN;
    • International Normalized ratio ≤ 1.5 × ULN (INR)/Prothrombin time (PT) and activated partial thromboplastin time (aPTT);
    • Creatinine ≤ 1.5 × institutional ULN OR;
    • Glomerular filtration rate (GFR) ≥ 51 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2). 
    • *No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment.
    • **No administration of G-CSF is allowed within 1 week prior to screening assessment.
  • Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization/enrollment.
  • Patients who are Human Immunodeficiency Virus (HIV) positive may participate IF they meet the following eligibility requirements:
    • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective.
    • They must have an undetectable viral load and a CD4 count ≥ 250 cells/µL within 7 days of enrolment.They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.
    • HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with brain metastases should be stable and off steroids and at least 4 weeks from radiation at the time of registration.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be better than class 2B.
  • The effects of DS-8201a and olaparib on the developing human fetus are unknown. For this reason and because HER2 antibody conjugated to a topoisomerase 1 inhibitor agents as well as PARP inhibitors are known to be teratogenic; thus, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 7 months (WOCBP only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of DS-8201a and olaparib administration. For methods considered as highly effective methods of contraception.
  • Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone [FSH] > 40 mIU/mL and estradiol < 40 pg/mL [<147 pmol/L] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
  • Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study.
  • Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
  • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible.


Exclusion Criteria:

  • Patients who have had chemotherapy (including antibody drug therapy) within 4 weeks with the following exceptions: 1 week for weekly paclitaxel; 2 weeks or five half-lives, whichever is longer, for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents, hormonal agents; or 6 weeks for nitrosoureas or mitomycin C.
  • Patients who have had radiation therapy within 4 weeks.
  • Patients who have had a major surgery within 4 weeks.
  • Patients who are receiving any other investigational agents.
  • For the dose expansion cohort: Patients who have received prior PARP inhibitors.
  • Patients with a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to DS-8201a, the inactive ingredients in the drug product, olaparib, or severe hypersensitivity to other monoclonal antibodies.
  • Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients with a medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class IIb to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization.
  • Patients with a corrected QT interval (QTc) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead ECG.
  • Patients with clinically significant corneal disease in the opinion of the Investigator.
  • Patients with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.
  • Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • Patients receiving chloroquine or hydroxychloroquine will require a washout period of ≥ 14 days to be eligible for the study.
  • Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤ 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy).
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because DS-8201a is a HER2 antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DS-8201a, breastfeeding should be discontinued if the mother is treated with DS-8201a. These potential risks may also apply to other agents used in this study.

Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug
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EvALuation of ECG transmission and AI moDels using Apple watch ECGs and Symptoms data collected usiNg a Mayo iPhone App (ALIGN)

EvALuation of ECG transmission and AI models using Apple watch ECGs and symptoms data collected usiNg a Mayo iPhone App

Paul Friedman
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303851-H01-RST
21-001964
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Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Using the Mayo patient iPhone app. (determined automatically via Mayo software).


Exclusion Criteria:

  • Inability to provide informed consent.
  • Age under 18 years.

 

 

 

 

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A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART) (ABAGART)

A Study to Evaluate Abatacept to Treat Giant Cell Arteritis

Kenneth Warrington
All
50 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-303854-P01-RST
21-001986
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Inclusion Criteria:

  • A diagnosis of newly-diagnosed or relapsing Giant Cell Arteritis (GCA).
  • Diagnostic criteria for GCA.
  • A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4 or 5:
    • Age at disease onset ≥ 50 years;
    • New onset or new type of localized pain in the head;
    • ESR of > 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit;
    • Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries);
    • Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant celor an abnormal temporal artery ultrasound showing features consistent with active giant cell arteritis (“halo sign”) or characteristic changes of large vessel stenosis or aneurysm by arteriography.
  • GCA with evidence of active disease (defined below) present within the past 8 weeks.
  • They must be willing and able to comply with treatment and follow-up procedures.
  • Both women and men who are of child-bearing potential must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
  • Must be willing and able to provide written informed consent.


Exclusion Criteria:

  • Evidence of a recent acute infection defined as:
    • Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics.
    • Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy.
  • Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).
  • Patients with a history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster. Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening.
  • Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).
  • Patients with a history of primary immunodeficiency.
  • Patients at risk for tuberculosis (TB) defined as follows:
    • Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated.  Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN- gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder;
    • A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines;
    • Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they:
      • Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and
      • They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. If permitted by local guidelines regarding treatment with biologic medications, patients with latent TB may be randomized prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.
  • Patients who are pregnant or who are nursing infants.
  • Inability to comply with study guidelines.
  • Cytopenia: platelet count < 80,000/mm³, total White Blood Count (WBC) < 3,000/mm³ (3 x 10⁹/L) absolute neutrophil <1500/mm³, hematocrit < 20%.
  • Renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min.
  • AST or ALT > 3 times above normal laboratory range.
  • Other severe, progressive, or uncontrolled disease that in the investigator’s opinion could prevent a patient from fulfilling the study requirements or that would increase the risk of study participation.
  • Patients who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
  • Receipt of an investigational agent or device within 30 days prior to enrollment.
  • A live vaccination within 3 months before randomization.
  • Patients on non-biologic immunosuppressants must discontinue these medications before randomization (azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, hydroxychloroquine, cyclosporin, tacrolimus, or other conventional immunosuppressive agent).
  • Patients who had received an alkylating agent such as cyclophosphamide must discontinue these medications at least 8 weeks before randomization.
  • Patients who have been treated within 4 weeks of randomization with etanercept or within 8 weeks with adalimumab, certolizumab, golimumab, or infliximab.
  • Patients who have been treated within 8 weeks of randomization with anti-IL-6 agents (e.g., tocilizumab, sirukumab) or a janus kinase inhibitor.
  • Patients who have been treated within 4 weeks of randomization with anakinra.
  • Patients who have received prior treatment with rituximab within the past 6 months prior to randomization.
  • Patients who have received prior treatment with abatacept or CTLA4-Ig.
  • Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA.
  • Hypersensitivity to abatacept and/or its excipients.
  • Presence of any of the following disease processes:
    • Takayasu arteritis;
    • Granulomatosis with polyangiitis;
    • Microscopic polyangiitis;
    • Eosinophilic granulomatosis with polyangiitis (Churg-Strauss);
    • Polyarteritis nodosa;
    • Cogan’s syndrome;
    • Behçet’s disease;
    • Sarcoidosis;
    • Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis;
    • Cryoglobulinemic vasculitis;
    • Systemic lupus erythematosus;
    • Rheumatoid arthritis;
    • Mixed connective tissue disease or any overlap autoimmune syndrome.
Drug, Other
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