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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.

3159 Study Matches

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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:


- Adults ≥18 to ≤80 years of age

- History of refractory or unexplained chronic cough

- Historical Chest radiograph or CT scan that does not demonstrate any abnormality
considered to be significantly contributing to chronic cough

- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method
of acceptable contraceptive for the trial duration, if applicable

- Agree to discontinue antitussive medications for the trial duration


Exclusion Criteria:


- Current smoker (including cannabis products) or previous smoker having recently given
up smoking or has a history of smoking of >20 pack-years

- History of significant cardiovascular disease or any clinically significant
abnormalities in rhythm or conduction

- History or presence of significant hepatic disease or any other condition known to
interfere with absorption, distribution, metabolism, or excretion of drugs.

- 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.

- Recent history of drug or alcohol abuse or a positive urine drug test at screening

- Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1
and HIV-2

- Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI
within 3 months of Screening.

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

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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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)

A Study of HFB200301 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:


- Previously received the following lines of systemic therapy for the
advanced/metastatic disease:

- Gastric cancer: at least 2 lines of therapy

- Renal cell carcinoma: at least 2 lines of therapy

- Melanoma:

- BRAF V600E mutant: must have received at least 2 lines of therapy

- BRAF V600E wild type: must have received at least 1 line of therapy

- Sarcoma: at least 1 line of therapy

- Testicular germ cell tumor: at least 2 lines of therapy

- Cervical cancer: at least 2 lines of therapy

- Mesothelioma: at least 2 lines of therapy

- Non-small cell lung cancer: at least 3 lines of therapy

- Head and neck squamous cell carcinoma: at least 2 lines of therapy

- Suitable site to biopsy at pre-treatment and on-treatment

- Measurable disease as determined by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma

- Eastern Cooperative Oncology Group performance status of 0 or 1


Exclusion Criteria:


- Systemic anti-cancer therapy within 2 weeks prior to start of study drug

- For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune
therapy

- Therapeutic radiation therapy within the past 2 weeks

- Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2)
receptor

- Active autoimmune disease requiring systemic treatment in the previous 2 years

- Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune
suppressive therapy

- Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer
therapy with the following exceptions:

- All grades of alopecia are acceptable

- Endocrine dysfunction on replacement therapy is acceptable

- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy,
or unstable psychiatric condition

- Major surgery within 2 weeks of the first dose of study drug

- History or presence of drug or non-drug induced interstitial lung disease or
pneumonitis ≥Grade 2

- 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

- Using sensitive substrates of major cytochrome P450 (CYP450) enzymes

- Known active malignancy, with the exception of the specific cancer under investigation
in this trial, that required treatment within the previous 2 years

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

Eligibility last updated 11/15/22. Questions regarding updates should be directed to the study team contact.

Drug
Cancer, Cervical cancer, Germ cell tumor, Head and neck cancer, Hypopharyngeal cancer, Kidney cancer, Laryngeal cancer, Lung cancer, Melanoma, Mesothelioma, Metastatic melanoma, Sarcoma, Skin cancer, Soft tissue sarcoma, Stomach cancer, Testicular cancer, Throat cancer
Cancer treatment, Digestive system, Epstein-Barr virus associated gastric carcinoma, Integumentary system, Medical Oncology, Musculoskeletal system, Reproductive system, Respiratory system, Targeted drug therapy, Urinary system
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Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Christi Patten
All
21 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-306821-H01-RST
22-000513
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Inclusion Criteria:

Index Participants will be eligible if they:

  • Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
  • Are aged ≥ 21 years (legal smoking age in Alaska).
  • Self-report smoking in the past 7 days, biochemically verified with breath expired air carbon monoxide (CO) > 4 ppm and saliva cotinine > 30 n/ml (positive Alere iScreen result).
  • Smoked > 3 cigarettes per day (cpd) over the past 3 months.
  • If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
  • Are considering or willing to make a quit attempt.
  • Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration.
  • Nominate one adult family member who will enroll.


Exclusion Criteria:

  • Used pharmacotherapy or a stop smoking program within the past 3 months.
  • Another person in the household is enrolled as the index participant.

Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:

  • Are ≥ 21 years old.
  • Are defined as family by the index participant.
  • Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration.
  • Both men and women and those from non-ANAI racial/ethnic groups.
  • Family members may only support one index participant to mitigate concern about lack of independence of household or other support networks, and potential for crosstreatment contamination, which could attenuate effects in the RCT.

Alaska Tribal Health System stakeholders:

  • Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.

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

Other
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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, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Esophageal cancer, Stomach cancer
Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Esophagectomy, Medical Oncology, Primary adenocarcinoma of esophagogastric junction, Radiation therapy
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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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Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® insulin lispro-aabc

Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc

Yogish Kudva
All
7 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307872-P01-RST
22-003830
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Inclusion Criteria:

  • Age 2-80 years at time of screening.
  • Has a clinical diagnosis of type 1 diabetes:
    • 14–80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis;
    • 7–13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis;
    • 2-6 years of age: A clinical diagnosis of type 1 diabetes for 6 months or more, as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
  • Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
  • Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
  • Subject and/or legally authorized representative is willing to provide informed consent for participation.
  • Is willing to perform fingerstick blood glucose measurements as needed.
  • Is willing to wear the system continuously throughout the study.
  • Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  • Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
    • Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
  • Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range, the Free T3 is below or within the lab’s reference range and Free T4 is within the normal reference range.
  • Uses pump therapy prior to screening:
    • 7-80 years of age: greater than 6 months prior to screening (with or without CGM experience);
    • 2-6 years of age: greater than 3 months prior to screening (with or without CGM experience).
  • Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
  • Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations as required during the run-in period: a. Humalog (insulin lispro injection) b. NovoLog (insulin aspart injection).
  • Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).


Exclusion Criteria:

  • Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®.
  • Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
    • Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization);
    • Coma;
    • Seizures. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
  • Has had DKA in the last 6 months prior to screening visit.
  • Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
  • Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  • Is female of child-bearing potential and result of pregnancy test is positive at screening.
  • Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
  • Is female and plans to become pregnant during the course of the study.
  • Is being treated for hyperthyroidism at time of screening.
  • Has diagnosis of adrenal insufficiency.
  • Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoid during the course of the study.
  • Is using hydroxyurea at time of screening or plans to use it during the study.
  • Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
  • Is currently abusing illicit drugs.
  • Is currently abusing marijuana.
  • Is currently abusing prescription drugs.
  • Is currently abusing alcohol.
  • Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
  • Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
  • Has elective surgery planned that requires general anesthesia during the course of the study.
  • Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  • Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  • Is diagnosed with current eating disorder such as anorexia or bulimia.
  • Has been diagnosed with chronic kidney disease that results in chronic anemia.
  • Has a hematocrit that is below the normal reference range of lab used.
  • Is on dialysis.
  • Has serum creatinine of > 2 mg/dL.
  • Has celiac disease that is not adequately treated as determined by the investigator.
  • Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
  • Has had history of cardiovascular event 1 year or more from the time of screening without:
    • a normal EKG and stress test within 6 months prior to screening or during screening; or
    • clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
  • Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:
    • Age > 35 years;
    • Type 1 diabetes of > 15 years’ duration;
    • Presence of any additional risk factor for coronary artery disease;
    • Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria);
    • Presence of peripheral vascular disease;
    • Presence of autonomic neuropathy.
  • Is a member of the research staff involved with the study.
Device, Drug
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Cardio-Oncology Clinic Registry

Cardio-Oncology Clinic Registry

Joerg Herrmann
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307886-H01-RST
22-003943
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Inclusion Criteria:

  • Patients referred to the Mayo Clinic cardio-oncology clinic.
  • Adults ≥ 18 years old.


Exclusion Criteria:

  • Individuals < 18 years old.
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Correlation Between Ovarian Axis Hormones and Adrenal Androgens and Measurements of Satiation, Postprandial Satiety, and Hunger in Pre- and Post-menopausal Women

Ovarian Axis Hormones and Adrenal Androgens and Measurements of Satiation, Postprandial Satiety, and Hunger in Pre- and Post-menopausal Women

Maria Hurtado Andrade
Female
18 years to 65 years old
This study is NOT accepting healthy volunteers
2022-307918-H01-RST
22-004063
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Inclusion Criteria:

Premenopausal group

  • Age 40-48 at the time of original study recruitment.
  • Regular menstrual periods for at least 1 year on no hormonal contraception at the time of their participation in the original study.

Postmenopausal group

  • Age 52-60 at the time of original study recruitment.
  • Confirmed menopausal status at the time of their participation in the original study: no menstrual periods for at least 1 year (but no more than 2 years).


Exclusion Criteria:

  • History of hysterectomy.
  • History of surgical, chemical, or radiation-induced menopause (i.e., oophorectomy, aromatase inhibitors, chemotherapy for cancer treatment, or radiation therapy).
  • Use of any drug that can affect estrogen production or signaling (e.g., GnRH agonists and antagonists, estrogen receptor modulators, etc.).
  • Use of systemic estrogen and/or progesterone (oral contraceptives, contraceptive implants, hormone replacement therapy).
  • Use of non-hormonal contraceptive methods that can affect the regularity of menstrual cycles (e.g., intrauterine devices).
  • History of hypothalamic or pituitary disease (e.g., pituitary adenomas, empty sella, pituitary surgery, hypothalamic masses).
  • Patients who denied future use of biological samples or further contact from the previous listed IRBs.

Eligibility last updated 4/18/22. Questions regarding updates should be directed to the study team contact.

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ROA2233: Pilot Study of PROS Monitoring

Pilot Study of PROS Monitoring

Allison Garda
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307933-H01-RST
22-004148
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Inclusion Criteria:

  • Female, 18 years of age or older.
  • Women treated for breast cancer with radiation with a curative intent


Exclusion Criteria:

  • Non breast cancer.
  • Children under 18-years of age.
  • Non curative intent.

Eligibility last updated 4/19/22.  Questions regarding updates should be directed to the study team contact.

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Initial Evaluation of the Pulmonary Hypertension Functional Class Self Report

A Study of Functional Class Self Report in Pulmonary Hypertension

Hilary DuBrock
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307941-P01-RST
22-004268
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Inclusion Criteria

  • ≥ 18 years of age.
  • Subject must have a clinician-recorded diagnosis of  Pulmonary Hypertension (PH).
  • Subject must have either PAH (WHO Group 1), PH due to left heart disease (WHO Group 2), PH due to lung disease (WHO Group 3), PH due to blood clots in the lungs (WHO Group 4), or PH with unclear and/or multifactorial mechanisms (WHO Group 5) based on a clinician-reported diagnosis.
  • Subject is able to read and complete an English-language electronic survey.
  • Subject has access to a computer or tablet to complete the electronic survey.
  • Subject is willing and able to provide electronic informed consent.


Exclusion Criteria:
 

  • ≤ 18 years of age. 

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

 

 

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Mixed Reality Technology Integration Into Clinical Care

Integration of Mixed Reality Technology Into Clinical Care

Trevor Simard
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2022-307964-H01-RST
22-004250
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Inclusion Criteria:
 

  • Age 18 to 100 years old.
  • Able to consent.


Exclusion Criteria:
 

  • Pregnant women, fetuses or neonaters.
  • Prisoners.
  • Children.
  • Adults lacking capacity to consent.

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

 

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Obesity-Induced Dysfunction of Human MSC in Peripheral Microvascular Repair

Dysfunction of Mesenchymal Stem/Stromal Cells Induced by Obesity

Lilach Lerman
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
2022-307980-H01-RST
22-004291
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Inclusion Criteria:

  • Group 1:
    • Age 18-80 years;
    • BMI ≥ 35 kg/m^2;
    • Eligible for bariatric surgery;
    • Ability to provide consent.
  • Group 2:
    • Age 18-80 years;
    • BMI ≤ 30 kg/m^2;
    • Undergoing live donor nephrectomy;
    • Ability to provide consent.


Exclusion Criteria:
 

  • Pregnancy.
  • Chronic Inflammatory Disease (e.g., rheumatoid arthritis).
  • Active malignancy.
  • Recent stroke or myocardial infarction.
  • Solid organ transplant recipients.
  • Therapeutic doses of immunosuppressive drugs (including calcineurin inhibitors and prednisone (> 10 mg/day).
  • Senolytic supplements.
  • Subjects on therapeutic doses of anticoagulants [including Warfarin (Coumadin), Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa)].
  • Subjects deemed ineligible to comply with study protocol.
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Evaluation of a Wearable Physiologic Monitor to Detect Sleep Quality

Evaluate Sleep Quality from Wearable Physiologic Monitor

Timothy Morgenthaler
All
19 years and over
This study is NOT accepting healthy volunteers
2022-308005-H01-RST
22-004369
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Inclusion Criteria:

  • Adults  > 18 years of age.
  • Body-Mass Index (BMI) < 35.
  • Normal sleep routine (typically awake during day and asleep at night).


Exclusion Criteria:
 

  • Prior diagnosis of, or positive STOP-BANG screen (> 3) for sleep apnea.
  • Excessive daytime sleepiness (the recorded Epworth Sleepiness Scale (ESS) must be ≤ 9).
  • History of heart failure, atrial fibrillation, pulmonary, neurological, or psychiatric disease.
  • Currently being treated pharmacologically for depression or other significant medical condition (broadly speaking).
  • Subject is receiving hypnotics or stimulant medication.
  • Habitual use of 3 or more cups of coffee/caffeinated tea per day.
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Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Trevor Simard
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308013-P01-RST
22-004385
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Inclusion Criteria:


1. Severe, calcific AS

2. Native aortic annulus size suitable for SAPIEN X4 THV

3. NYHA functional class ≥ II

4. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent.


Exclusion Criteria:


1. Anatomical characteristics that would preclude safe femoral placement of the
introducer sheath or safe passage of the delivery system

2. Aortic valve is unicuspid, bicuspid or non-calcified

3. Pre-existing mechanical or bioprosthetic valve in any position

4. Severe aortic regurgitation (> 3+)

5. Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis

6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months

7. Left ventricular ejection fraction < 20%

8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

9. Left ventricular outflow tract calcification that would increase the risk of annular
rupture or significant PVL after THV implantation

10. Increased risk of coronary artery obstruction after THV implantation

11. Myocardial infarction within 30 days prior to the study procedure

12. Hypertrophic cardiomyopathy with subvalvular obstruction

13. Subjects with planned concomitant ablation for atrial fibrillation

14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous
coronary intervention (PCI)

15. Any surgical or transcatheter procedure within 30 days prior to the study procedure
(unless part of planned strategy for treatment of CAD). Implantation of a permanent
pacemaker or implantable cardioverter defibrillator (ICD) is not considered an
exclusion.

16. Any planned surgical or transcatheter intervention to be performed within 30 days
following the study procedure (unless part of planned strategy for treatment of CAD)

17. Endocarditis within 180 days prior to the study procedure

18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to
carotid or vertebrobasilar disease within 90 days prior to the study procedure

19. Hemodynamic or respiratory instability requiring inotropic or mechanical support
within 30 days prior to the study procedure

20. Renal insufficiency and/or renal replacement therapy

21. Leukopenia, anemia, thrombocytopenia

22. Inability to tolerate or condition precluding treatment with antithrombotic therapy

23. Hypercoagulable state or other condition that increases risk of thrombosis

24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
treated with premedication

25. Subject refuses blood products

26. BMI > 50 kg/m^2

27. Estimated life expectancy < 24 months

28. Female who is pregnant or lactating

29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that
could confound endpoint assessments

30. Participating in another investigational drug or device study that has not reached its
primary endpoint

Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.

Device
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated with Osteoarthritis

Osteoarthritis Injectable Treatment with SL-1002 to Assess the Safety and Efficacy

Ryan D'Souza
All
35 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308040-P01-RST
22-004991
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Inclusion Criteria:

  • Male or female patients, 35 years of age or older, with a Body Mass Index (BMI) of 18.0 to 40.0 kg/m^2 and a total body weight of ≥ 50.0 kg for males and ≥ 45.5 kg for females.
  • Patients with chronic knee pain resulting from osteoarthritis for greater than 6 months prior to study Screening Visit 1 that interferes with functional activities (e.g., ambulation, prolonged standing, etc.).
  • Patients currently experiencing continued pain despite receiving at least 3 months of conservative treatments, inclusive of activity modification, home exercise, protective weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
  • Patients with a baseline average pain score of ≥ 6 on an 11-point NRS scale as “usual level of pain over the past 24 hours during weight-bearing actives” for the index knee at Screening. The baseline average pain score is computed by finding the mean of the daily NRS pain intensity scores reported during the 7-day run in period.
  • Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit 1.
  • Patients with a baseline average WOMAC Knee Score Group of ≥ 2 (0 to 4 scale) for pain (question A1) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale obtained from daily WOMAC pain subscale completion during the screening 7-day run in period.
  • Patients taking analgesics, inclusive of membrane stabilizers (e.g., Neurontin/gabapentin) and/or antidepressants (e.g., Cymbalta/duloxetine), for osteoarthritis associated knee pain must be on a stable dose for at least 6 weeks prior to study Screening Visit 1. Patients must agree to not alter the dose of analgesics for the duration of the study without prior approval from the Investigator.
  • Female patients of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
    • Intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
    • Male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
    • Hormonal contraceptives starting at least 4 weeks prior to study drug administration must agree to use the same hormonal contraceptive throughout the study;
    • Sterile male partner (vasectomized since at least 6 months).
  • Female patients of non-childbearing potential as defined below:
    • Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause);
    • Pre-menopausal females with one of the following:
      • Documented tubal ligation;
      • Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion;
      • Hysterectomy;
      • Documented bilateral oophorectomy.
  • Patients must agree to see one treating physician (study Investigator) for knee pain treatment for study duration.
  • Patients who have a positive response to a single genicular nerve block of the index knee using 1.5
    •3mL of lidocaine 2% solution administration to the genicular nerves planned for treatment in each cohort (0.5mL per nerve). A positive response to the qualifying lidocaine prognostic block is defined as ≥ 80% pain reduction within 60 minutes of receiving the lidocaine injections and ≥ 80% pain relief for a duration of at least 60 minutes as documented on a standardized 6-hour pain log.
  • Patients must be able to understand and be able to complete all assessments associated with the study outcome measures.
  • Patients must be able to understand the informed consent and be willing to provide written informed consent. Patients must be able to comply with the requirements of the protocol for the entire duration of the study.


Exclusion Criteria:
 

  • Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any other systemic inflammatory condition (e.g., gout, pseudogout).
  • Current diagnosis of fibromyalgia.
  • Patients with evidence of neuropathic pain affecting the index knee.
  • Patients with prior or planned lower limb amputation.
  • Patients who have received an intra-articular steroid injection into the index knee within 90 days of study Screening Visit 1.
  • Patients who have received hyaluronic acid injection, PRP, stem cell or arthroscopic debridement/lavage injection into the index knee within 180 days of study Screening Visit 1.
  • Patients who have received prior radiofrequency ablation or any other neurolytic procedure of the genicular nerves of the index knee within 1 year of study Screening Visit 1.
  • Patients who have received prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware).
  • Patients with clinically significant ligamentous laxity of the index knee as per Investigator discretion.
  • Patients with clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of the knee) that materially affects gait or function of the index knee or is the underlying cause of the knee pain and/or functional limitations.
  • Patients who are extremely thin and those with minimal subcutaneous tissue thickness that could place the patient at risk of a chemical skin burn, at the discretion of the Investigator.
  • Patients with a pending or active compensation claim, litigation or disability remuneration (possibility of secondary gain).
  • Patients with chronic pain associated with significant psychosocial dysfunction.
  • Patients with a Patient Health Questionnaire – 9 (PHQ-9) score of > 10 (indicative of a state of moderate depression).
  • Patients with a systemic infection, active joint infection, or localized infection at the planned needle entry sites (patient may be considered for inclusion once infection is resolved).
  • Patients with history of uncontrolled coagulopathy or unexplained or uncontrollable bleeding that cannot be corrected.
  • Patients with severe hepatic or renal impairment that, in the judgement of the Principal Investigator, will preclude participation in the study.
  • Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
  • Patients currently prescribed opioid medications at a dose of > 50 daily morphine equivalents.
  • Patients with uncontrolled immunosuppression (e.g., AIDs, cancer, diabetes) as per Investigator discretion.
  • Female patients who are pregnant or planning to become pregnant during the duration of the study.
  • Female patients who are breast-feeding.
  • Patients who are unable or unwilling to comply with the requirements of the protocol.
  • Patients taking any of the following concurrent medications/over-the counter products (refer to Appendix 8 in full protocol for a list of applicable medications):
    • Probenecid or other OAT3 inhibitors;
    • Inhibitors of CYP2E1, such as disulfiram.
  • Patients with known allergies or hypersensitivity to iodinated contrast medium and gadolinium-based contrast medium. Known allergies or hypersensitivity to phenol and/or lidocaine and/or their excipients.
  • Patients with a documented history or evidence of alcohol or drug abuse within 1 year of study screening visit 1.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days of study Screening Visit 1, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Patients with clinically significant ECG abnormalities or vital sign abnormalities at during study Screening Visit 1. Patients with ECG or vital sign abnormalities deemed nonclinically significant or unlikely to result in clinical compromise by the Principal Investigator may be considered for study inclusion.
  • Patients with clinically significant laboratory results (as judged by the Principal Investigator).
  • Any condition, in the opinion of the Principal Investigator, that may pose a significant risk to the patient, confound the results of the study or interfere significantly with the patient’s participation in the study.

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

Drug, Other
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Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis

Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis

Roberto Benzo
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308098-H01-RST
22-004626
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Inclusion Criteria:

  • Adult patients, ≥ 18 years old.
  • Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
  • Ability to communicate in English.


Exclusion Criteria:

  • Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
  • Cognitive impairment or inability to understand and follow instructions.
  • Traditional PR completed within 3 months of study recruitment.
  • Hospice or end-of-life care at the time of screening.
  • Acute exacerbation at the time of screening.

Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.

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Preliminary Evaluation of At-Home Self-Collection for Pre-Transplant Patients

At-Home Self-Collection for Pre-Transplant Patients

Manish Gandhi
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308101-H01-RST
22-004659
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Inclusion Criteria:

  • Adult (≥ 18 years) pre-transplant kidney patient.


Exclusion Criteria:

  • Individuals < 18 years.
  • Not pre-transplant kidney patient.

Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.

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GRASP-IBD (GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease) (GRASP-IBD)

GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease

John Davis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308107-H01-RST
22-004690
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Inclusion Criteria:

  • Adult patients, ages 18-70 years.
  • Patients with Irritable Bowel Disease (IBD).


Exclusion Criteria:

  • Patients < 18 and over 70 years of age.

Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.

 

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A Review of Midgut Malrotation in the Adult Population: Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure

Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure: A Review of Midgut Malrotation

William Perry
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308114-H01-RST
22-004723
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Inclusion Criteria:

  • Patients who underwent Ladd’s procedure. 


Exclusion Criteria:
  

  • < 18 years of age.

 

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Gait Analysis in Aging and Neurological Disease

Analyzing Patient Gait in Aging and Neurological Disease

Farwa Ali
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308150-H01-RST
22-004877
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Inclusion Criteria:

  • Any consenting adult over the age of 18 presenting to the Mayo Clinic Study of Aging will be included.
  • Any consenting adult presenting to the department of Neurology with a gait disorder will be included.


Exclusion Criteria:
 

  • Individuals under the age of 18.
  • Individuals who are immobile (defined as unable to walk with or without a gait aid) will be excluded.
  • Individuals with severe cognitive or neuropsychiatric impairment which may affect their gait or makes them unable to provide informed consent will be excluded.
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Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)

68GaFAPI-46 PET/CT for Pancreatic Ductal Adenocarcinoma

Ajit Goenka
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308153-P01-RST
22-004884
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Inclusion Criteria:

  • Adults ≥ 18 years old.
  • Have treatment-naïve biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI, or PET).
  • Localized disease expected to undergo surgical resection following NAT.
  • ECOG performance status of 0-2.
  • Ability to provide informed consent.


Exclusion Criteria:

  • Hypersensitivity to any excipients in 68Ga-FAPI-46.
  • Require emergency surgery.
  • Non-PDA histology on biopsy.
  • Histopathologically proven metastatic PDA.
  • Pregnant women.

Eligibility last updated 5/6/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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A Phase 1b/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-0974 in Participants With Myelofibrosis and Anemia

Study of DISC-0974 in Participants With Myelofibrosis and Anemia

Naseema Gangat
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308216-P01-RST
22-005120
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Inclusion Criteria:


1. Age 18 years or older at the time of signing the informed consent (ICF).

2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4
(intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as
confirmed in the most recent local bone marrow biopsy report, according to World
Health Organization (WHO) 2016 criteria.

3. Washout of at least 28 days prior to Screening of the following treatments: androgens,
erythropoietin, cladribine, immunomodulators (lenalidomide, thalidomide), interferon
alpha-2a or any other MF-directed therapy. Systemic corticosteroids are permitted for
non-hematological conditions if stable or decreasing dose for ≥ 28 days prior to
Screening and receiving an equivalent to ≤ 10 mg prednisone for the 28 days
immediately prior to Screening.

4. Anemia: For Phase 1b: Hemoglobin (Hgb) < 10 g/dL on ≥ 3 assessments over 84 days prior
to Screening, without RBC transfusion, or Hgb < 10 g/dL and receiving RBC transfusions
periodically but not meeting criteria for TD participant as defined for the TD cohort.
The baseline Hgb value for these participants is the lowest Hgb level during the 84
days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units packed RBCs (PRBC) over the 84 days immediately prior to
Screening. There must not be any consecutive 42-day period without an RBC transfusion
in the 84-day period, and the last transfusion must be within 28 days prior to
Screening. For Phase 2a: RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units PRBC over the 84 days immediately prior to Screening. There
must not be any consecutive 42-day period without an RBC transfusion in the 84-day
period, and the last transfusion must be within 28 days prior to Screening.

5. Stable dose of JAK inhibitor and/or hydroxyurea, or, if taking any other treatment for
MF, stable for at least 4 months prior to Screening.

6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.

7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after
Screening.

8. Liver iron concentration by MRI < 7 mg/g dry weight.

9. Serum ferritin ≥ 30 µg/L at Screening.

10. Platelet count ≥ 25,000/µL and < 1,000,000/µL; neutrophils ≥ 1,000/µL; and total white
blood cell (WBC) count < 50,000/µL at Screening.

11. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 by the Chronic Kidney
Disease-Epidemiology Collaboration (CKD-EPI) formula.

12. Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0 x upper limit of
normal (ULN) at Screening.

13. Direct bilirubin < 2x ULN at Screening. Higher levels are acceptable if these can be
attributed by the Investigator to ineffective erythropoiesis.


Exclusion Criteria:


Medical History:

1. Hereditary hemochromatosis

2. Hemoglobinopathy or intrinsic RBC defect associated with anemia

3. Splenectomy

4. Hematopoietic cell transplant

5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or
bleeding

6. Active immune-mediated hemolytic anemia

7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or
bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units
of RBCs in the 6 months prior to Screening

8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any
previous surgery

9. Malignancy within the past 3 years, other than primary MF, post-ET, or post-PV MF. The
following history or concurrent conditions are allowed:

1. basal or squamous cell carcinoma

2. carcinoma in situ of the cervix or the breast

3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
metastasis [TNM] clinical staging system)

10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior
to Screening

11. Known allergic reaction to any study drug excipient, or anaphylaxis to any food or
drug

12. A history of anti-drug antibody formation

13. Inadequately controlled heart disease (New York Heart Association Classification 3 or
4) and/or known to have left ventricular ejection fraction < 35%

14. Active Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral
load

15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to
the infection, without improvement despite appropriate treatment)

Treatment History:

16. Concurrent or planned treatment with momelotinib during the study period

17. Iron chelation therapy in the 3 months prior to Screening

18. Change in anticoagulant therapy regimen within 8 weeks prior to Screening

Laboratory Exclusions:

19. Peripheral blood myeloblasts ≥ 10% of WBC differential at most recent evaluation prior
to Screening

20. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at
Screening

Drug
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Vitamin D-Sulfates in Breastmilk

Study of Breastmilk With Vitamin D-Sulfates

Thomas Thacher
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-308273-H01-RST
22-005324
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Inclusion Criteria:

  • Lactating women.
  • ≥ 2 weeks after delivery.
  • No intentions of weaning during the study.


Exclusion Criteria:
 

  • History of sarcoidosis.
  • History of renal disease.
  • Premature birth.
  • Taking daily supplement with ≥ 600 IU vitamin D in the past 30 days (accounting for washout period).
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Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op)

Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology

Kathryn Van Abel
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-308294-H01-RST
22-005420
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Inclusion Criteria:

  • Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester.
  • Age ≥ 18.
  • Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC.

Exclusion Criteria

  • HPV() OPSCC.
  • Unable to provide informed consent.
  • Unwilling to attend screening visit at Mayo Clinic site, if indicated.
  • Non-English speaking.
  • Unwilling/unable to complete surveys electronically.
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Assessing the Utility of Disc Space Aspirate Cell Count and Differential in the Diagnosis of Native Vertebral Osteomyelitis

Diagnosis of Native Vertebral Osteomyelitis by Assessing the Utility of Disc Space Aspirate Cell Count and Differential

Elie Berbari
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308313-H01-RST
22-005791
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Inclusion Criteria:

  • Patients 18 years of age or older.
  • Referred to the neuroradiology department for diagnostic image guided biopsy.
  • The reason for image-guided biopsy would either be due to suspicion for NVO or for other reasons such as ruling out malignancy.


Exclusion Criteria:

  • Patients less than 18 years of age.
  • Patients with spinal hardware / instrumentation.
  • Post operative patients.
  • Patients unable to provide consent.

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

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Examining the Sociocultural Influences on Menstrual Health and Uterine Fibroids among Latinas and Black Women

Cultural Experiences of Black and Hispanic/Latina Women with Uterine Fibroids

Felicity Enders
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-308337-H01-RST
22-005762
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Inclusion Criteria:

  • Over the age of 18 years of age.
  • Biologically female.
  • Self-reported diagnosis of symptomatic uterine fibroids.
  • Self-identify as Black/African American and/or Hispanic/Latina.


Exclusion Criteria:

  • Under the age of 18.
  • Biologically male.
  • Not diagnosed with symptomatic uterine fibroids.
  • Does not self-identify as Black/African American and/or Hispanic/Latina.

Eligibility last updated 5/26/22. Questions regarding updates should be directed to the study team contact.

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Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial (VIP BOLT)

A Trial of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Mauricio Villavicencio Theoduloz
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308359-H01-RST
22-005691
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Inclusion Criteria:

  • Bilateral LTx recipients.
  • > 18-year-old and be able to provide consent.
  • Mean pulmonary artery pressure < 35 mmHg.
  • Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

 


Exclusion Criteria:

  • Single lung transplant.
  • Multiorgan transplant.
  • DCD donor.
  • Retransplant.
  • Intention to use prophylactic post-operative ECMO.
  • Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion.
  • Previous Pleurodesis.
  • Preoperative ECMO and/or mechanical ventilation.
  • Non-English Speaking patients.

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

Procedure/Surgery
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Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating

Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Xiao Jing Wang
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308387-H01-RST
22-005844
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Inclusion Criteria:

  • Patients who meet Rome IV criteria for functional abdominal bloating/distension.
  • Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
  • Patients will be proficient in English language for comprehension of content.
  • Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.


Exclusion Criteria:

  • Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
  • Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
  • Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
  • Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
  • Patients with substance abuse disorders and drug addiction will be excluded.
  • Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.   

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

  

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Mayo Clinic — Rochester, MN

Molecular Breast Imaging (MBI) Patient Survey

Patient Survey of Molecular Breast Imaging

Carrie Hruska
Female
21 years and over
This study is NOT accepting healthy volunteers
2022-308388-H01-RST
22-006013
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Inclusion Criteria:

  • Female.
  • MBI exam performed at Mayo Clinic in Rochester, MN.
  • Email address provided in the medical record.


Exclusion Criteria:

  • Protected research populations (pregnant women, prisoners, children, and adults lacking capacity to consent) will not be included in the study.

Eligibility last updated 6/7/22. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

Molecular prediction of Helicobacter pylori antimicrobial resistance patterns

Helicobacter Pylori Antimicrobial Resistance Patterns Using Molecular Prediction

Robin Patel
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308424-H01-RST
22-005955
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Inclusion Criteria:

  •  ≥  18 years of age. 
  • Suspected of having a H. pylori infection and are undergoing or recently have undergone a gastric biopsy.


Exclusion Criteria:

  • On a current antibiotic regimen and negative for H. pylori as tested from a gastric biopsy.

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.

 

I'm interested
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Location Contacts
Mayo Clinic — Rochester, MN