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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.

2962 Study Matches

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Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE)

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Derek Lomas
Male
50 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-306482-P01-RST
21-012020
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Inclusion Criteria:

  • Is greater than 50 years of age.
  • Has at least a 10-year life expectancy.
  • Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c.
  • Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL.
  • Has Gleason score 3+4 or 4+3.
  • Has no evidence of extraprostatic extension by mpMRI.
  • Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy.
  • Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation.
  • Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion.
  • A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy).
  • Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject.
  • Understands and accepts the obligation and is logistically able to present for all
  • scheduled follow-up visits.


Exclusion Criteria:

  • Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium.
  • Is unfit for anesthesia or has a contraindication for agents listed for paralysis.
  • Has an active urinary tract infection (UTI).
  • Has a history of bladder neck contracture.
  • Is interested in future fertility.
  • Has a history (within 3 years) of inflammatory bowel disease.
  • Has a concurrent major debilitating illness.
  • Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer.
  • Has any active implanted electronic device (e.g., pacemaker).
  • Is unable to catheterize due to a urethral stricture disease.
  • Has had prior or current prostate cancer therapies:
    • Biologic therapy for prostate cancer;
    • Chemotherapy for prostate cancer;
    • Hormonal therapy for prostate cancer within three months of procedure;
    • Radiotherapy for prostate cancer;
    • Surgery for prostate cancer.
  • Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants.
  • Has had prior major rectal surgery (except hemorrhoids).
  • Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)).
  • Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder.
  • Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons.
  • In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual.

Eligibility last updated 4/6/22. Questions regarding updates should be directed to the study team contact.

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A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups

A Study of Educational Materials for Hiccups

Aminah Jatoi
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306492-H01-RST
21-012057
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Inclusion Criteria:

  • Age ≥ 18 years of age.
  • Hiccups in the 4 weeks prior to phone contact (patient must confirm).
  • Able to speak and read English.
  • Has an e-mail address.


Exclusion Criteria:
 

  • Individuals < 18 years of age.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

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Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum (DBS)

Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum

Elitza Theel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306510-H01-RST
21-012151
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Inclusion Criteria:

  • Subjects who are ≥ 18 years of age.
  • Subjects who are known to be positive for syphilis antibodies using routine, standard of care serologic assays.


Exclusion Criteria:
 

  • Subjects who are < 18 years of age.
  • Subjects who are unable to give informed consent.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

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IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients by Using a 20 Hz Filter to Better Assess Electrocardiogram Abnormalities (IQ-ECG)

IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306589-H01-RST
21-013016
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Inclusion Criteria:

  • Adults ≥ age of 18 years.
  • Must have a left ventricular assist device (LVAD).
  • Must be able to consent.


Exclusion Criteria:

  • No LVAD.
  • Unable to consent.
  • Under the age of 18 years.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (FibroGen095)

Zephyrus II: Effectiveness and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Teng Moua
All
40 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306608-P01-RST
21-012801
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Key

Inclusion Criteria:


1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.

2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.

3. FVCpp value >45% and <95% at Screening and Day 1.

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and
≤90%.

5. Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib)
but discontinued at least 1 week prior to screening, unless neither treatment is
available in the host country.

Key
Exclusion Criteria:


1. Previous exposure to pamrevlumab.

2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.

3. Female participants who are pregnant or nursing.

4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
study.

5. Interstitial lung disease other than IPF.

6. Sustained improvement in the severity of IPF.

7. Other types of respiratory diseases that, in the opinion of the Investigator, would
impact the primary protocol endpoint or otherwise preclude participation in the study,
including diseases of the airways, lung parenchyma, pleural space, mediastinum,
diaphragm, or chest wall.

8. Certain medical conditions, that, in the opinion of the Investigator, would impact the
primary protocol endpoint or otherwise preclude participation in the study (such as,
myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or
cancers).

9. Acute IPF exacerbation during Screening or Randomization including hospitalization due
to acute IPF exacerbation within 4 weeks prior to or during screening.

10. Recent use of any investigational drugs or unapproved therapies, or participation in
any clinical trial.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient.

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact

Biologic/Vaccine, Other
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A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People with Severe Von Willebrand Disease (VWD) (ATHN 9)

ATHN 9: Severe Von Willebrand Disease Natural History Study

Rajiv Pruthi
All
Not specified
This study is NOT accepting healthy volunteers
2021-306671-P01-RST
21-013017
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Inclusion Criteria:

  • Males and females.
  • Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPIbM or VWF:Ag ≤ 30% of pooled normal control plasma on more than one occasion.
  • Participants with clinically severe VWD as defined by VWF:RCo or VWF:Ag ≤ 40% of normal with severe bleeding phenotype defined as requiring use of recurrent factor concentrates.
  • Co-enrollment in the ATHN dataset.

Exclusion Criteria

  • Diagnosis of platelet-type VWD;
  • Diagnosis of acquired VWD (clinical diagnosis made by the hemophilia health care provider, typically based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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TILT – T563: A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination with Pembrolizumab in Patients with Platinum Resistant or Refractory Ovarian Cancer (PROTA)

A Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) Combined with Pembrolizumab to Treat Refractory Ovarian Cancer

Matthew Block
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306701-P01-RST
22-000078
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Inclusion Criteria:


- Signed and dated informed consent(s) by the participant or legal representative before
any trial-related activities.

- Female over 18 years of age on day of signing informed consent(s).

- Histologically confirmed ovarian cancer (including fallopian tube and primary
peritoneal cancer) resistant to platinum (defined as progression of cancer within 183
days of the most recent dose of cisplatin or carboplatin) or refractory to platinum
(defined as progression of cancer within 30 days of the most recent dose of cisplatin
or carboplatin) ovarian cancer, which cannot be treated with curative intent with
available therapies. Note: Poly(ADP)-ribose polymerase (PARP) inhibitors should be
considered as indicated in clinical practice, prior to trial enrollment.

- At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local
virus injection (intratumoral and/or intraperitoneal).

- The disease burden must be evaluable, but does not need to fulfil RECIST 1.1.

- Have adequate organ function as defined in the following values below. Specimens must
be collected within 10 days prior to the start of study treatment.

a. Hematological laboratory values i. Absolute neutrophil count (ANC): ≥1500/µL ii.
Platelets: ≥ 100 000/µL iii. Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be
met without packed red blood cell (pRBC) transfusion within the prior 2 weeks.
Participants can be on stable dose of erythropoietin (≥ approximately 3 months. iv.
Leukocytes (WBC) > 3.0 b. Renal laboratory values i. Glomerular Filtration Rate (GFR):
>60 ml/min (Cockcroft-Gault formula). c. Hepatic laboratory values i. Total bilirubin:
≤1.5 × Upper Limit of Normal (ULN) OR direct bilirubin ≤ULN for participants with
total bilirubin levels >1.5 × ULN (excluding patients with Gilbert's Disease) ii.
Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT):
≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

- Patients must be willing to use adequate forms of contraception from screening, during
the trial, and for a minimum of 120 days after end of treatment, in accordance with
the following:

i. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be
used in addition to one of the following methods: Intrauterine devices or hormonal
contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings
or long-acting injections). ii. Women not of childbearing potential: Barrier
contraceptive method (i.e. condom) must be used.

- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
score of 0-1 at screening.

- Life expectancy longer than 3 months.

- Capable of understanding and complying with parameters as outlined in the protocol.


Exclusion Criteria:


- Has an 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) and inhaled and topical
treatments are not considered a form of systemic treatment and are allowed.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study drug.

- Treated with any anti-cancer therapy within 30 days prior to the first virus
injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. surgery,
chemotherapy, immune-checkpoint inhibitors, kinase inhibitors, PARP inhibitors,
biological therapies, hormonal therapies, radiation, etc.). Continuation of hormonal
therapy or use of bone modifying agents (e.g. bisphosphonate or denosumab) is allowed
if started at least 3 months before.

- Participants must have recovered from all Adverse Events (AE)s due to previous
therapies to ≤Grade 1or baseline. Participants with ≤Grade 2 neuropathy may be
eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or
hormone replacement may be eligible. If the participant had major surgery, the
participant must have recovered adequately from the procedure and/or any complications
from the surgery prior to starting study intervention.

- Treated with a prior radiotherapy, including for palliative purposes, within 2 weeks
of start of study treatment (before or after). Participants must have recovered from
all radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
weeks of radiotherapy) to non-Central Nervous System (CNS) disease. Palliative
radiation is allowed from day 15 during the trial treatment period, if deemed
necessary by the investigator.

- Treated with a prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
Cytotoxic T lymphocyte-associated Antigen (CTLA)-4, Tumor necrosis factor receptor
superfamily, member 4 (OX40), CD137), and was discontinued from that treatment due to
a Grade 3 or higher immune-related Adverse Events (irAE).

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 30 days prior to the first virus
injection. An investigational agent is any drug or therapy that is currently not
approved for use in humans. Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the last
dose of the previous investigational agent.

- Uncontrolled cardiac or vascular diseases.

- History of myocardial infarction or cerebral stroke within the previous 12 months
before screening or is not sufficiently recovered from an older infarction or cerebral
stroke.

- History of severe hepatic dysfunction.

- History of hepatitis B (defined as HBsAg reactive), Hepatitis C (defined as hepatitis
C virus (HCV) RNA [qualitative] is detected) and/or HIV. No testing for Hepatitis B,
Hepatitis C and HIV is required unless mandated by a local health authority.

- History of coagulation disorder.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's
participation for the full duration of the study, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator.

- Female patients who are pregnant, breastfeeding or intend to become pregnant. Women of
childbearing potential who has a positive urine pregnancy test (within 72 hours) prior
to treatment. If the urine test is positive or cannot be confirmed as negative, a
serum pregnancy test will be required.

- Has a known additional malignancy that is progressing or has required active treatment
within the past 5 years. Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not excluded.

- Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 3 months by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.

- Has an active infection requiring systemic therapy.

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study.

- Allergy to ingredients present in the investigational medicinal products (ingredients
are listed in the protocol) ie. severe hypersensitivity (≥Grade 3) to pembrolizumab
and/or any of its excipients.

- Known contraindications to pembrolizumab.

- Has had an allogenic tissue/solid organ transplant.

- Has received a live or live-attenuated vaccine within 30 days prior to the first dose
of study intervention. Administration of killed vaccines are allowed.

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

 

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S2104 Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Timothy Hobday
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306702-P01-RST
21-013251
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Inclusion Criteria:

  • Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam.
  • Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report.
  • Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be ≥ 3% and ≤ 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria.
  • Participants with localized resected pNETS must have a Zaidi score of ≥ 3 derived by the following factors and points:
    • 1 point; symptomatic tumor defined as one of the following:
      • Gastrointestinal bleed;
      • Jaundice;
      • Gastrointestinal obstruction;
      • Pain from primary tumor prior to surgical resection;
      • Pancreatitis.
    • 2 points; primary pancreas tumor size > 2 cm.
    • 1 point; Ki-67 3% to 20% -1 point; lymph node positivity = 1.
    • 6 points; Ki-67 21% to 55%.
  • Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection.
  • Participants must not have unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must have recovered from effects of surgery as determined by the treating investigator.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must be ≥ 18 years old
  • Participants must have Zubrod performance status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to registration.
  • Patients must have adequate organ and marrow function as defined below within 28 days prior to registration:
    • Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration);
    • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration);
    • Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration);
    • Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration);
    • Serum creatinine ≤ 1.5 x institutional ULN (within 28 days prior to registration);
    • Calculated creatinine clearance ≥ 50 ml/min (within 28 days prior to registration).
    • Calculated Creatinine Clearance = (140
      •age) X (weight in kg) † 72 x serum creatinine:
    • * Multiply this number by 0.85 if the participant is female.
    • † The kilogram weight is the participant weight with an upper limit of 140% of the IBW.
    • * Actual lab serum creatinine value with a minimum of 0.8 mg/dL.
  • Participants must be able to swallow pills.
  • Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential."In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  • No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years.
  • 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 unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Eligibility last updated 12/27/21. Questions regarding updates should be directed to the study team contact.

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Evaluating Paternal Antigen Exposure and Maternal Immune Tolerance

Evaluating Paternal Antigen Exposure

Elizabeth Ann Enninga
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306706-H01-RST
21-013107
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Inclusion Criteria:

  • Pregnant women ≥ 18 years old, having their second pregnancy.
  • Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems.
  • Ability to provide informed written consent.
  • No known pregnancy complications at the first obstetrics visit (uncomplicated pregnancy).
  • Known paternity for pregnancy.
  • Singleton pregnancies.


Exclusion Criteria:
 

  • History of preeclampsia or other hypertensive disease.
  • History of preterm delivery.
  • History of miscarriage.
  • History of stillbirth.
  • History of prior fetal growth restriction.
  • Current pregnancy with congenital anomaly.
  • Mothers < 18 years of age.
  • Multiple fetuses.
  • Conception following assisted reproductive technologies.

Eligibility last updated 12/17/21. Questions regarding updates should be directed to the study team contact.

Other
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Mayo Clinic Phage Program Biobank (Phagebank)

Mayo Clinic Phage Program Biobank

Gina Suh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306707-H01-RST
21-013112
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Able to provide informed consent.
  • Individual must have a future treatment plan to receive or has historically received phage therapy.


Exclusion Criteria:

  • Individuals , 18 years of age.
  • Unwilling/unable to provide informed consent.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

 

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Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Roberto Benzo
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306737-P01-RST
21-013228
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
  • The ability to read and respond to questions in English or Spanish.
  • Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
  • Life expectancy at least 6 months.


Exclusion Criteria:

  • Individuals < 18 years.
  • Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

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

Behavioral
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A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Open Nipple Sparing Mastectomy (NSM)

James Jakub
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-306747-P01-RST
21-006696
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Inclusion Criteria:

  •  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.


Exclusion Criteria:
  

  • Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

 

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Cardiovascular and Cognitive Implications of CNS hypersomnias and Their Treatments (CVCOGNARCIH)

Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition

Virend Somers
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306758-H01-RST
21-013321
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Inclusion Criteria:

  • Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
  • Age 18
    •75 years.
  • BMI between 18 and 40 kg/m^2.
  • Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
  • If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
  • If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication before starting new medication.


Exclusion Criteria:
 

  • Any change to medication(s) within the last 45 days.
  • History of chronic alcohol or drug abuse within the prior 12 months.
  • Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
  • Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit.
  • Participation in another study of an investigational drug within the 28 days prior to screening visit or currently.
  • Pregnancy and/or breast-feeding.
  • Subjects who, in the opinion of the Investigator, may not be suitable for the study.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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Mayo Clinic — Rochester, MN

Tonation Breathing Technique, a Non-pharmacogenic Method to Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms - A Pilot Study (TBT)

Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms

Prema Peethambaram
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306764-P01-RST
21-012300
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Inclusion Criteria:

  • Eligible patients are females with stage I-III breast cancer taking adjuvant AI (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled. Treating physicians determine if pain is secondary to an AI.  
  • ≥ 18 years old.
  • Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment.
  • Patients should have an ECOG performance score of 0-2. 


Exclusion Criteria:

  •  Age less than 18 years.
  • Significant underlying pulmonary disease.

Eligibility last updated 1/14/22.  Questions regarding updates should be directed to the study team contact.

 

Behavioral
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Prospective Collection of Blood and Urine of Healthy Individuals for Liquid Biopsy Research (HDEV)

Liquid Biopsy Controls

Fabrice Lucien-Matteoni
All
50 years and over
This study is NOT accepting healthy volunteers
2021-306772-P01-RST
21-013474
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Inclusion Criteria:

  • Able to give informed consent.
  • Adults  > 50 years old.
  • No prior cancer diagnosis.


Exclusion Criteria:
 

  • Individuals < 50 years old.
  • Unable or unwilling to provide informed consent.

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

 

 

 

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A Double-Blind, Randomized, Placebo Controlled, Two Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administrated Orally to Subjects with Chronic Cough (ADX-629-CC-001)

Evaluating the Safety, Tolerability and Effectiveness of ADX-629 t to Treat Chronic Cough

Vivek Iyer
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306794-P01-RST
22-000292
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Inclusion Criteria:

  • Male or female adults (≥ 18 to ≤ 80 years of age at screening).
  • Written informed consent must be provided before any protocol-specific screening procedures are performed.
  • History of refractory or unexplained chronic cough for > 1 year prior to screening that is unresponsive to at least 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma, and post-nasal drip; or for which no objective evidence of an underlying trigger can be determined after investigation.
  • Awake cough count at screening of 10 or more coughs/hour.
  • Cough severity score at screening of ≥ 40 mm on the cough severity visual analogue scale (VAS).
  • Chest radiograph or computed tomography (CT) scan performed within 5 years before screening and after the onset of chronic cough that does not demonstrate any abnormality considered to be significantly contributing the chronic cough, in the opinion of the Investigator.
  • Females of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) who:
    • has a negative serum pregnancy test at screening;
    • are not breastfeeding or lactating;
    • agrees to use a highly effective method of acceptable contraceptive for the trial duration and at least 30 days after the last dose in the trial.
  • Females of non-childbearing potential must be either surgically sterile (i.e., hysterectomy, bilateral tubal ligation, salpingectomy, or bilateral oophorectomy at least 26 weeks prior to screening) or post-menopausal, defined as spontaneous amenorrhea for at least 1 year, with follicle-stimulating hormone (FSH) blood levels of equal or greater than 40 mIU/mL at the Screening Visit.
  • Males who are surgically sterile, or:
    • males with female partners of childbearing potential who agrees to use a highly effective method of acceptable contraceptive for at least 30 days after the last dose in the trial;
    • agrees to abstain from sperm donation through 30 days after administration of the last dose of the trial treatment.
  • Agreement to discontinue acetaminophen (paracetamol) and antitussive medications (dextromethorphan, opioids, gabapentin, pregabalin, baclofen, tricyclic antidepressants) during the trial period and agree to limit consumption of caffeine, grapefruit juice, cruciferous vegetables, and grilled meat to no more than one serving per day during the study.


Exclusion Criteria:

  • Current smoker (e.g., cigarettes, e-cigarettes, nicotine patches) including cannabis products; or previous smoker having given up smoking ≤12 months before screening or has a history of smoking >20 pack-years or the equivalent nicotine strength at any time or has cotinine test > 10 ng/mL at screening.
  • Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of < 60%.
  • Active upper respiratory tract infection or recent significant change in pulmonary status that, in the opinion of the Investigator, could affect the conduct or outcome of the trial and that is documented by a physician within 4 weeks before the first dose of trial treatment.
  • Uncontrolled hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 90 mmHg at screening.
  • Prolonged QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 440 ms or shortened QTcF < 340 ms at screening, or history of significant tachycardia, bradycardia, acute or chronic cardiovascular disease or any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG).
  • Elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin levels > 2.0 × upper normal limits.
  • History or presence of gastrointestinal, hepatic disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Acute or chronic renal disease or medical history of renal disease with estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m^2 calculated by Chronic Kidney Disease Epidemiology (CKD-EPI) equation or spot urine protein to creatinine ratio (sUPCR) > 2000 mg/g (226 mg/mmol, as an estimate of approximate proteinuria > 2 g/day) at screening.
  • History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
  • Taking disallowed concomitant medications (strong CYP1A2, CYP2B6, and CYP3A4 inhibitors) during the trial period.
  • History of severe hypersensitivity or ongoing clinically significant hypersensitivity to ADX-629.
  • User of recreational or illicit drugs or history of drug or alcohol abuse within the last 6 months, or a positive urine drug test or alcohol breath test at screening.
  • Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV-1 and HIV-2) at screening.
  • Positive screening test for, or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or documented history of prior infection in the past 6 months prior to screening.
  • Current or recent participation in another interventional trial within 90 days prior to screening.
  • Any clinically significant abnormalities or findings from examination, tests, or medical history that may compromise subject safety. Potential issues of concern should be raised with the Medical Monitor.
  • Any unstable or uncontrolled acute or chronic diseases/conditions that in the Investigator’s opinion could affect the conduct or outcome of the trial.
  •  Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of screening.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients with Advanced Solid Tumors (HFB-200301-01)

Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients with Advanced Solid Tumors

Konstantinos Leventakos
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306800-P01-RST
22-000038
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Inclusion Criteria:

  • Patient must have the ability to understand and voluntarily sign a written informed consent form (ICF) and willingness and ability to comply with all protocol requirements. If consent cannot be obtained in writing, it must be documented and witnessed.
  • Patient must have signed informed consent prior to any study procedure.
  • Patient must be male or non-pregnant/non-lactating female (a negative serum pregnancy test at Screening is mandatory) ≥ 18 years of age.
  • Patient must have histologically documented and advanced or metastatic solid tumors. The following tumor types are permitted:
    • EBV+ gastric cancer as determined on archival material by in situ hybridization or other institutional standard based on local laboratory data;
    • Clear cell renal cell carcinoma;
      • Histological confirmation of renal cell carcinoma with a clear cell component includes participants who may also have mixed tumors with a prevalent clear cell histology.
    • Cutaneous melanoma;
    • Soft tissue sarcoma;
    • Testicular germ cell tumors;
    • PD-L1+ cancers (combined positive score [CPS] or tumor positive score [TPS] ≥ 1 or PD-L1-stained, tumor-infiltrated immune cells of any intensity covering ≥ 1% of the
      tumor area) as determined by an FDA-approved test on an archival tumor specimen based on local, available laboratory data. The following tumor types are permitted:
      • Cervical cancer;
      • Pleural mesothelioma;
      • Lung adenocarcinoma;
      • Head and neck squamous cell carcinoma with a primary site of the oral cavity, oropharynx, larynx, or hypopharynx.
    • Patient must have previously received the following lines of systemic therapy for the advanced/metastatic disease:
      • EBV+ gastric cancer: Patient must have received at least 2 lines of therapy (but no more than 4) including fluoropyrimidine, platinum-based regimens, and anti-PD-1/PD-L1 inhibitors as a single agent or in combination. HER-2+ patients must have received an anti-HER-2 treatment;
    • Clear cell renal cell carcinoma: at least 2 lines of therapy (but no more than 3) such as vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs), mammalian target of rapamycin (mTOR) inhibitors, or anti-PD-1/PD-L1 inhibitors as single agents or in combination;
    • Cutaneous melanoma:
      • BRAF V600E mutant: Patient must have received at least 2 lines of therapy (but no more than 3) including anti-PD-1/PD-L1 inhibitors as single agents or in combination (such as anti-CTLA-4 therapy) and BRAFV600E inhibitor therapy either as a single agent or in combination with a MEK inhibitor;
      • BRAF V600E wild type: Patient must have received at least 1 line of therapy (but no more than 2) including anti-PD-1/PD-L1 inhibitors as single agents or in combination (such as anti-CTLA-4 therapy).
    • Soft Tissue Sarcoma: at least 1 line of Standard of Care therapy (but no more than 2);
    • Testicular germ cell tumor: at least 2 lines of Standard of Care therapy (but no more than 3);
    • PD-L1+ cervical cancer: at least 2 lines of therapy (but no more than 3) including bevacizumab in combination with chemotherapy and an anti-PD-1 inhibitor as a single agent or in combination;
    • PD-L1+ pleural mesothelioma: at least 2 lines of therapy (but no more than 3) including platinum-based regimens and an anti-PD-1 inhibitor as a single agent or in combination;
    • PD-L1+ non-small cell lung cancer adenocarcinoma: at least 3 lines of therapy (but no more than 4) including platinum-based regimens and anti-PD-1/PD-L1 inhibitors. Patients with known oncogenic driver alterations must have failed TKIs;
    • PD-L1+ head and neck squamous cell carcinoma: at least 2 lines of therapy (but no more than 3 systemic therapies) including platinum-based regimens, epidermal growth factor receptor (EGFR) inhibitors (eg, cetuximab), or anti-PD-1/PD-L1 inhibitors as single agents or in combination.
  • Patient must have a site suitable to biopsy according to the treatment institution’s guidelines. Patient must be willing to undergo pre-treatment and on-treatment biopsies.
  • Patient must have measurable disease, defined as at least 1 lesion measured in at least 1 dimension by computed tomography (CT) scan, magnetic resonance (MR) imaging, or calipers by clinical exam as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma.
  • Patient has an Eastern Cooperative Oncology Group performance status of 0 or 1.


Exclusion Criteria:

  • Patient received systemic anti-cancer therapy within 2 weeks prior to start of study drug. For cytotoxic agents with major delayed toxicity (e.g., mitomycin C), 6 weeks of washout are mandated.
  • For soft tissue sarcoma and testicular germ cell tumor patients only: Patient received prior immune therapy; e.g., targeting PD-1, PD-L1, CTLA-4, or immune agonist antibodies.
  • Patient received therapeutic radiation therapy within the past 2 weeks (palliative radiotherapy to a limited field is allowed).
  • Patient received prior exposure to agents targeting the TNFR2 receptor.
  • Patient has an active autoimmune disease requiring systemic treatment in the previous 2 years.
    • Note: This includes patients with a history of inflammatory bowel disease, ulcerative colitis and Crohn’s Disease, rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain Barré Syndrome, myasthenia gravis, multiple sclerosis), and moderate or severe psoriasis. However, patients with rheumatoid arthritis or psoriasis in stable remission for at least 6 months and without contraindications to possible co-treatment with corticosteroids for immune-related adverse events, vitiligo, Sjogren’s syndrome, interstitial cystitis, Graves’or Hashimoto’s disease, or hypothyroidism stable on hormone replacement are permitted.
  • Patient has laboratory values (indicating organ and bone marrow dysfunction) defined as:
    • Absolute neutrophil count ≤ 1.0 × 10^9/L;
    • Platelet count ≤ 100 × 10^9/L;
    • Hemoglobin < 9.0 g/dL or equivalent. Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Patients can be on a stable dose of erythropoietin (≥ 3 months);
    • Total bilirubin > 1.5 × upper limit of normal (ULN) or > 3.0 × ULN unless known Gilbert syndrome has been diagnosed;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3.0 × ULN;
    • Serum creatinine > 1.5 × ULN or creatinine clearance < 40 mL/min using Cockcroft-Gault formula.
  • Patient received systemic steroid therapy (> 10 mg/day of prednisone or equivalent) or any immune suppressive therapy. Replacement-dose steroids for managing adrenal insufficiency within 7 days of first study treatment and non-systemic steroids; topical, intraocular, intranasal, intra-articular, or inhalation steroids are allowed.
  • Patient has persisting toxicity of ≥ Grade 2 (≥ Grade 1 for diarrhea) NCI CTCAE version 5.0 relating to prior anti-cancer therapy with the following exceptions:
    • All grades of alopecia are acceptable;
    • Endocrine dysfunction on replacement therapy is acceptable.
  • Patient has symptomatic or uncontrolled CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression requiring concomitant treatment such as surgery, radiation, or steroids (≥ 10 mg/day of prednisone or equivalent);
    • Note: Patients are eligible if neurologic symptoms and CNS imaging are stable for 14 days prior to the first dose of study drug and do not require systemic steroids (≥ 10 mg/day of prednisone or equivalent) for symptom control.
  • Patient has severe or unstable cardiac conditions including, but not limited to, the following:
    • Congestive heart failure (New York Heart Association Class III or IV);
    • Uncontrolled hypertension;
    • Uncontrolled cardiac arrhythmia requiring medication (≥ Grade 2 according to NCI CTCAE version 5.0);
    • Myocardial infarction within 6 months prior to starting study drug, or any other significant or unstable concurrent cardiac illness;
    • Congenital long QTcF interval > 470 msec at Screening.
  • Patient has severe or unstable medical condition, including uncontrolled diabetes, coagulopathy (where the Investigator considers interruption of anticoagulation for biopsies as high risk), or unstable psychiatric condition;
  • Patient had major surgery within 2 weeks of the first dose of study drug;
  • Patient has known infections, including the following:
    • Human immunodeficiency virus, hepatitis B virus (HBV) (i.e., hepatitis B surface antigen positive), or hepatitis C virus (HCV) (i.e., detectable HCV RNA);
      • Note: Patients with a prior history of HBV infection who are surface antigen negative (treated/untreated) or patients with a prior history of treated HCV infection who are HCV RNA undetectable may be enrolled.
        Patients whose disease is controlled under antiviral therapy should not be excluded.
    • Active infections requiring systemic therapy (including asymptomatic infections with positive virus titers and the Investigator’s judgment that worsening of the condition is likely with study drug or the condition would impair or prohibit a patient’s participation in the study).
  • Patient has received a live vaccine within 30 days prior to the first dose of study drug. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations should not be administered within ±14 days of HFB200301 infusion
  • Patient has a history or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥ Grade 2;
  • Patient has a history of allergic reactions, immune-related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301.
  • Patient is using sensitive substrates of major cytochrome P450 (CYP450) enzymes.
  • Patient has a known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years. Exceptions include basal or squamous cell skin cancer, superficial bladder cancer, or other tumors that,in the opinion of the Investigator, should not impact life expectancy.
  • If patient is a woman of childbearing potential, defined as a woman physiologically capable of becoming pregnant, she must use a highly effective method of contraception during treatment and for 3 months following the last dose of study drug. Highly effective methods of contraception are highly effective birth control methods with a failure rate of < 1% per year when used consistently and correctly, including:
    • Combined estrogen- and progestin-containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally; progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant; intrauterine devices; and intrauterine hormone-releasing systems;
    • Female sterilization (surgical bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal occlusion/ligation) at least 6 weeks before study treatment;
    • Male sterilization (at least 6 months prior to first study treatment dose);
    • Complete sexual abstinence. Periodic abstinence (e.g., calendar) and withdrawal are not acceptable. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
  • If patient is male able to father children, he must agree to use 2 acceptable methods of contraception throughout the study (e.g., condom plus spermicidal gel). Sperm donation is prohibited during the duration of participation in this study and for 30 days after the last dose of study drug.

Eligibility last updated 1/4/22. Questions regarding updates should be directed to the study team contact.

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EA2174, A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Shanda Blackmon
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-306824-P01-RST
22-000135
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Inclusion Criteria:

STEP 1:

  • Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II).
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy.
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Hemoglobin (Hgb) ≥ 9 g/dL (within less than or equal to 14 days prior to randomization).
  • Leukocytes ≥ 3,000/mm^3 (within less than or equal to 14 days prior to randomization).
  • Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy.
  • Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy.
  • Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy.
  • Patients must have no contraindication to receiving radiation therapy.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
    • Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years.
  • Date of last evidence of disease.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs.
  • For patients with evidence of CHF, myocardial infarction (MI), cardiomyopathy, or myositis, cardiac evaluation including lab tests and cardiology consultations including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram.
  • Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility.
  • Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from carboplatin, paclitaxel, or nivolumab. All females of childbearing potential must have a blood test or urine study done within 2 weeks prior to registration to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
  • If patient says 'Yes' to "I choose to take part in the imaging study and will have the diffusion weighted magnetic resonance imaging (MRI) scans": patients must be able to tolerate MRI scans:
    • No history of untreatable claustrophobia;
    • No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies;
    • Weight compatible with limits imposed by the MRI scanner table.

STEP 2:

  • Patient registration must not exceed 12 weeks from time of esophagectomy.
  • Patients must have a post-operative ECOG performance status of 0-2
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • AST (SGOT)/ ALT (SGPT) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical computed tomography (CT) scan. Patients must also have a negative surgical margin (R0 resection).
  • Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from nivolumab or ipilimumab. All females of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to registration to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy.
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine, Radiation
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Mayo Clinic — Rochester, MN

Evaluation of Cochlear Implantation at Mayo Clinic (ECI)

Evaluation of Cochlear Implantation

Matthew Carlson
All
Not specified
This study is NOT accepting healthy volunteers
2022-306830-H01-RST
22-000183
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Inclusion Criteria:

  • All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
  • If patients declined MN research authorization, they may be contacted for consent for approval.


Exclusion Criteria:

  • Patients that did not undergo cochlear implantation at the Mayo Clinic.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

 

 

 

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Mayo Clinic — Rochester, MN

Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia (SCOPE-L)

Specialty Compared to Oncology Delivered Palliative Care for Treating Acute Myeloid Leukemia

Jacob Strand
All
18 years to 120 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-306867-P01-RST
22-000288
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Inclusion Criteria
•Patient:

  • Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
    • Patients with new diagnosis ≥ 60 years of age;
    • An antecedent hematologic disorder;
    • Therapy related-disease;
    • Relapsed or primary refractory AML.
  • Receiving treatment with either:
    • intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or
    • hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.

Inclusion Criteria
•Caregiver:

  • Adult (≥ 18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.

Exclusion Criteria
•Patient:

  • Patients with a diagnosis of acute promyelocytic leukemia (APML).
  • Patients with AML receiving supportive care alone.
  • Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures.

Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.

 

Behavioral
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Mayo Clinic — Rochester, MN

Reducing Opioids after Percutaneous Stone Surgery (ROPES)

Reducing Opioid Prescription After Kidney Stone Removal Surgery

Kevin Koo
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306921-H01-RST
22-000494
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Inclusion Criteria:

  • Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
  • Adults ≥ 18 years old.
  • Ability to receive and respond to electronic text messages.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Patients who require Intensive Care Unit admission after surgery.
  • Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Advanced Cardiac Imaging Processing with the MUSIC Software for Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Konstantinos Siontis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306923-H01-RST
21-010613
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Inclusion Criteria:
           

  • Male or female adults (≥ 18 years old).
  • Frequent premature ventricular complexes or documented episode(s) of sustained VT, or evidence of appropriate ICD therapy in patients already implanted with ICDs.
  • Structural heart disease, defined as impairment of left ventricular ejection fraction on echocardiography or MRI and/or presence of structural abnormality on imaging (myocardial late gadolinium enhancement on MRI, myocardial wall thinning, hypodensity or calcification on MDCT), and/or borderline, possible or definite diagnosis of arrhythmogenic right ventricular cardiomyopathy according to modified Task Force criteria.


Exclusion Criteria:
 

  • Contraindications to VT/PVC catheter ablation:
    • Current intra-cardiac thrombus;
    • Unstable angina and other acute or reversible cause;
    • Current or anticipated participation in any other clinical trial of a drug, device or biologic.
  • Unwillingness to undergo CT and/or MRI imaging.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions

The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions

Juan Brito Campana
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306930-H01-RST
22-000518
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Inclusion Criteria
•Patients:

  • Adults ≥ 18 years
  • Appointment to discuss osteoporosis management

Exclusion Criteria
•Patients:

  • Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment)

Inclusion Criteria
•Clinicians:

  • Clinicians who meet with patients to discuss osteoporosis management.

Exclusion Critieria
•Clinicians:

  • None

Inclusion Critieria
•PAG Members:

  • Adults ≥ 18 years
  • Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Osteoporosis
Musculoskeletal system, Osteoporosis screening
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Mayo Clinic — Rochester, MN

Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage’win Pilot Preparatory Study (Aim 1)

Wiidookaage'win

Christi Patten
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306942-H01-RST
22-000477
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Inclusion Criteria - Phase 1:

AIAN Women

  • AIAN based on self-reported race.
  • Gender identity as a woman.
  • Resides in Minnesota.
  • At least 18 years of age age with no upper age limit.
  • OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013).
  • Self-reports at least one month of opioid abstinence based on Timeline Follow-Back (TLFB) interview.
  • Currently receiving MOUD.
  • Is comfortable speaking and reading English.
  • Is familiar with Facebook.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.
  • OUD, if other substance use, opioids are primary substance used.
  • Self-reports at least one month of opioid abstinence based on TLFB interview.
  • Currently receiving MOUD.
  • Is comfortable speaking and reading English.
  • Has an existing FB account or willing to create a FB account.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.
  • Willing and able to travel to Minneapolis, MN.

AI/AN Health Care Providers and Stakeholders

  • Health care provider or AIAN community stakeholder.
  • Knowledge of Native culture and/or OUD treatment and recovery among AIAN people.
  • Is comfortable speaking and reading English.
  • Is familiar with Facebook.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.

Inclusion Criteria
•Phase 3:

  • AIAN person based on self-reported race/ethnicity.
  • Gender identity as a woman.
  • At least 18 years of age.
  • Resides in MN.
  • OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013).
  • Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen.
  • Currently receiving MOUD.
  • Is comfortable speaking and reading English.
  • Has an existing Facebook account or willing to set one up.
  • Is willing and able to participate in the Facebook intervention for one month.
  • Has access to broadband internet on a mobile phone/computer/tablet at any location.
  • Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS.


Exclusion Criteria:

AIAN potential participants in Phases 1 and 3 meeting any of the exclusion criteria listed below will be excluded from study participation. Community stakeholder participants in Phase 1 will only fail the screening if they meet the second exclusion criterion:

  • Self-reports current suicidality.
  • Inability or unwillingness of participant to provide verbal consent (Phase 1) or written informed consent (Phase 3).
  • (Phase 3 only) Was a participant in Phase 1.

Pregnant women, lactating women, or women who plan to become pregnant will not be excluded because the treatment being evaluated is a behavioral intervention and does not involve medication or risk to the fetus.

Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.

Behavioral
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Mayo Clinic — Rochester, MN

Natural History of Myhre Syndrome (MS)

Examining the Natural History of Myhre Syndrome

Lisa Schimmenti
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306944-H01-RST
21-013116
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Inclusion Criteria:

  • 18 years or older.
  • Diagnosis of Myhre Syndrome.


Exclusion Criteria:

  • Individuals < 18 years of age.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

TORNIER PERFORM™ Stemless Reverse IDE Study (TORNIER PERFORM™ Stemless Reverse IDE Study)

TORNIER PERFORM™ Stemless Reverse IDE Study

Joaquin Sanchez-Sotelo
All
18 years and over
Post Market
This study is NOT accepting healthy volunteers
2022-306965-P01-RST
22-000653
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Inclusion Criteria:

  • Adult subject 18 years or older.
  • Scapula and proximal humerus must have reached skeletal maturity.
  • Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy.
  • Willing and able to comply with the protocol.
  • Willing and able to sign the informed consent form.
  • Patients with an adjusted Constant Score ≤ 65.


Exclusion Criteria:

  • Active local or systemic infection, sepsis, or osteomyelitis.
  • In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
  • In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
  • In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
  • In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
  • Metabolism disorder that could compromise bone formation, or Osteomalacia.
  • Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
  • Known allergy or suspected allergy to the materials.
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Medical condition(s) or balance impairments that could lead to falls (e.g., epilepsy not well-controlled with medication, Multiple Sclerosis, etc).
  • Previous failed arthroplasty.
  • Nonfunctional deltoid muscle.
  • Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
  • Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
  • Currently, or within the last six months, or planning to be on chemotherapy or radiation.
  • Recent or ongoing alcohol or drug abuse as determined by the investigator.
  • Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
  • Currently enrolled in any clinical research study that might interfere with the current study.
  • Known history of severe depression.
  • Primary insurance is Workers’ Compensation.
  • The study has completed 109 implant attempts for the randomized treatment arm.
  • Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
  • Chronic shoulder dislocation with or without fracture, > 6 weeks.
  • Parkinson’s disease.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty

Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient TJA

Matthew Abdel
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306974-H01-RST
22-000012
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Inclusion Criteria:

  • Adult patients age ≥ 18.
  • Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.


Exclusion Criteria:

  • Individuals < 18 years of age.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer (MNCCTN023)

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Stephan Thome
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-306982-P01-MAIJ
22-000839
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Ability to read and write in English.
  • Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
  • Treatment plan includes chemotherapy.
  • Able to provide written voluntary consent before performance of any study related procedure.
  • Aim 1 only: after completion of initial chemotherapy.
  • Aim 2 only: prior to starting chemotherapy.


Exclusion Criteria:

  • Inability to provide informed consent.
  • Exposure to chemotherapy prior to ovarian cancer diagnosis.
  • Life expectancy < 3 months or in hospice care or nursing home.
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Mayo Clinic Health System — Mankato, MN

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer (MNCCTN023)

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Mina Hanna
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-306982-P01-ALCL
22-000839
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Ability to read and write in English.
  • Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
  • Treatment plan includes chemotherapy.
  • Able to provide written voluntary consent before performance of any study related procedure.
  • Aim 1 only: after completion of initial chemotherapy.
  • Aim 2 only: prior to starting chemotherapy.


Exclusion Criteria:

  • Inability to provide informed consent.
  • Exposure to chemotherapy prior to ovarian cancer diagnosis.
  • Life expectancy < 3 months or in hospice care or nursing home.
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Mayo Clinic Health System — Albert Lea, MN

Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot

Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot

Christopher McLeod
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306992-P01-RST
22-000295
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Inclusion Criteria:

  • Patients with TOF or TOF-related variants.
  • Age ≥ 18 years.
  • Planned transcatheter valve placement in native RVOT.


Exclusion Criteria:

  • Individuals < 18 years.
  • Non-TOF related variants (i.e., pulmonary stenosis, PA-IVS, etc.).
  • Prior catheter or surgical ablation of ventricular tachycardia (VT).

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN