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3289 Study Matches

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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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Mayo Clinic — Rochester, MN

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 Protocol to Establish a Biobank of Controls for Post-COVID Studies

COVID Controls

Ravindra Ganesh
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306797-H01-RST
22-000008
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Inclusion Criteria:
  

  • Age ≥ 18 years.
  • Age and gender matched to biorepository cohort.
  • Population specific: 
    • For the never-COVID group – no history of having contracted COVID;
    • For COVID infection without post COVID cohort (+ COVID,
      •PASC), part of initial acute COVID biorepository;
    • time from onset of symptoms matched to biorepository cohort. 
    • For the + PASC group Included in the PASC biorepository.
  • Matched by age, sex and time of onset of symptoms, as appropriate be able to participate fully in all aspects of the study; and  
  • Have understood and signed study informed consent. 


Exclusion Criteria:
   

  • Active persistent COVID infection. 
  • < 40 kg in weight have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence. 
  • Women with a previously confirmed infection with the novel SARS-CoV-2 virus of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.   

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 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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A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors (TRUST-II)

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Anastasios Dimou
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306818-P01-RST
22-000109
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Inclusion Criteria:


1. Patient age ≥ 18 years (or ≥ 20 years as required by local regulations).

2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
NSCLC or other solid tumors.

3. Evidence of ROS1 fusion in tumor tissue determined by molecular assays as performed in
Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent
laboratories.

4. Patients with central nervous system (CNS) involvement, including leptomeningeal
carcinomatosis, which is either asymptomatic or previously treated and controlled, are
allowed; the use of seizure prophylaxis is allowed as long as patients are taking non
enzyme inducing anti-epileptic drugs (non-EIAEDs). If corticosteroid treatment is
required, it should be on stable or decreasing dose of ≤10 mg prednisone or
equivalent. If patients have neurological symptoms or signs due to CNS metastasis,
patients need to complete whole brain radiation or gamma knife irradiation treatment
at least 14 days before enrollment and be clinically stable.

5. The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s).

6. At least one extracranial measurable unirradiated lesion per RECIST 1.1 assessed by
investigator.

7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.

8. Patient with a life expectancy ≥12 weeks based on the judgement of investigators.

9. Patients with adequate organ function meeting the following criteria:

1. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤3 × upper
limit of normal (ULN) (or ≤5 × ULN, in case of liver abnormalities due to liver
metastases)

2. Serum total bilirubin: ≤1.5 × ULN

3. Absolute neutrophil count: ≥1,500/?L

4. Platelet count: ≥100,000/?L

5. Hemoglobin: ≥ 9.0 g/dL

6. Serum creatinine: ≤1.5 × ULN

10. Males and/or females who meet any of the following criteria:

1. For males (irrespective of surgical sterilization [vasectomy]): agree to use
effective contraception methods during the study intervention period and for at
least 90 days after the last dose of investigational drug or agree with complete
abstinence;

2. For females be post-menopausal for at least one year prior to screening or be
documented surgically sterilized. Women of childbearing potential (WOCBP) must
agree to use two concurrent effective methods of contraception or agree with
complete abstinence from sexual intercourse since the informed consent until 90
days after the last dose of investigational drug. Usage of hormonotherapy for
contraception should be recorded as well.

11. The patient is willing and capable to give written informed consent.

12. For all females of childbearing potential, a negative pregnancy test must be obtained
within 7 days of initial administration.

13. Willingness and ability to comply with the study scheduled visits, treatment plans,
laboratory tests and other procedures.


Exclusion Criteria:


1. Investigational agent or anticancer therapy within 2 weeks (or 5 half-lives of the
compound, whichever is longer) prior to study enrollment. In addition, no concurrent
anticancer therapy is permitted.

2. Previously treated with immuno-oncology (IO) including immune checkpoint inhibitors
within 12 weeks before enrollment.

3. Major surgery within 4 weeks prior to enrollment.

4. Radiation therapy with a limited field for palliation within 1 week of the first dose
of study treatment.

5. Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs
not constituting a safety risk to the patient based on the judgment of investigators.

6. Patients with spinal cord compression caused by tumor and/or cancerous meningitis.

7. History or evidence of interstitial fibrosis or interstitial lung disease or
pneumonitis.

8. Any gastrointestinal disorders that may affect absorption of oral medications.

9. Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV) or hepatitis C virus (HCV), known human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

10. Clinically significant cardiovascular diseases within 3 months prior to the first dose
of investigational drug: myocardial infarction, severe/unstable angina,
coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder
including transient ischemic attack.

11. Ongoing cardiac dysrhythmias of ≥ CTCAE 5.0 Grade 2, uncontrolled atrial fibrillation
of any grade, or QT interval corrected for heart rate (QTc) interval > 470 milliseconds
(female) or QTc interval > 450 milliseconds (male), or symptomatic bradycardia < 45
beats per minute.

12. Pregnancy or lactation.

13. Patients with other severe medical or mental diseases in whom the risk is increased by
the participation to the study or treatment with investigational drug in the opinion
of the investigator.

Drug
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Mayo Clinic — Rochester, MN

The Effects of Glucagon on Hepatic Metabolism

The Effects of Glucagon on Hepatic Metabolism

Adrian Vella
All
25 years to 65 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306820-H01-RST
22-000113
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Inclusion Criteria;

  • Age > 25 or < 65 years.
  • HbA1c ≥ 8.5%.
  • BMI ≤ 28 Kg/M^2 (for lean participants).
  • BMI ≥ 25 Kg/M^2 (for obese participants).
  • Use of diet, sulfonylureas or metformin only (for T2DM participants).
  • For female subjects: negative pregnancy test at the time of enrollment and study.
  • No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • No active systemic illness or malignancy.
  • No symptomatic macrovascular or microvascular disease.
  • No contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit > 35%.
  • TSH > 0.4 or < 5.5.
  • Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.
  • No allergy to iodine.


Exclusion Criteria:

  • Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≥ 8.5%.
  • BMI ≤ 28 Kg/M^2.
  • Use of insulin or agents other than sulfonylureas or metformin.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%.
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
  • Allergy to iodine.

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

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Mayo Clinic — Rochester, MN

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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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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MC220301 Targeted Prevention of Post-Partum-Related Breast Cancer

Study of Aspirin for the Prevention of Post-partum-Related Breast Cancer

Kathryn Ruddy
Female
18 years to 45 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-306842-P01-RST
22-000606
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Inclusion Criteria
•Pre-Registration:

  • Age ≥ 18 years and ≤ 45 years of age.
  • Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy.
  • Had a live birth ≤ 5 years prior to pre-registration.
  • Pre-menopausal.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willingness to provide mandatory blood and urine specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.

Inclusion Criteria
•Registration:

  • Age ≥ 18 years and ≤ 45 years of age.
  • Histological confirmation of benign breast disease (i.e., no evidence of DCIS or invasive cancer).
  • Registration must be completed ≤ 30 days after pre-registration biopsy performed for this study.
  • Hemoglobin ≥ 9.0 g/dL (obtained ≤ 30 days prior to registration).
  • Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to registration.
  • Serum creatinine ≤ 2.0 mg/dl (obtained ≤ days prior to registration).
  • Negative pregnancy test done ≤ 7 days prior to registration.
  • Willing to use contraception while on treatment.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willingness to provide mandatory blood and urine specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.
  • Willing to return to enrolling institution for follow-up.

Exclusion Criteria
•Pre-Registration:

  • History of breast cancer including ductal breast carcinoma in situ (DCIS).
  • Received systemic treatment for any other cancer at any time.
  • Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within ≤ 5 days prior to pre-registration and no more than four doses within ≤ 30 days prior to pre-registration).
  • Currently taking other agents for the prevention of breast cancer.
  • Currently taking anticoagulants.
  • Contraindication for aspirin use.

Exclusion Criteria
•Registration:

  • No research tissue collected during pre-registration biopsy performed for this study.
  • Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
    • NOTE: no doses within ≤ 5 days prior to registration and no more than four doses within ≤ 30 days prior to registration.
  • Co-morbid illnesses/conditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Any contraindication to aspirin use including but not limited to:
    • Bleeding disorders (e.g., hemophilia);
    • Stomach or intestinal bleeding ≤ 6 months prior to registration;
    • Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Currently taking anticoagulants.
  • Any malignancy requiring systemic therapy.
  • Currently pregnant or planning to become pregnant in the next 90 days.
  • Post-menopausal:
    • Prior bilateral surgical oophorectomy; or
    • No menses for > 1 year with estradiol levels within postmenopausal range, according to institutional standard.

Eligibility last updated 1/3/23. Questions regarding updates should be directed to the study team contact.

 

Behavioral, Drug
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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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(CAMPERR) cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)

Lisa Boardman
All
40 years and over
This study is NOT accepting healthy volunteers
2022-306871-P01-RST
22-000686
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Case

Inclusion Criteria:


- Newly diagnosed (within 90 days) with cancer or a recurrence of a cancer diagnosed > 5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical,
Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple
Myeloma.

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Case
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Simultaneously diagnosed with two or more invasive cancers.

- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years.

- Currently diagnosed with any chronic hematopoietic cancer (e.g., chronic CLL) in addition to the index cancer.

- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g., MGUS) in addition to the index cancer.

- Women who are known to be pregnant (self-reported).

Control
Inclusion Criteria:


- Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed).

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Control
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Women who are known to be pregnant (self-reported).

Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.

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Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Saad Kenderian
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306884-P01-RST
22-000405
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Inclusion Criteria:

  • The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable.
  • The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
  • In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.


Exclusion Criteria:

  • None.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)

Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension

Hilary DuBrock
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306899-H01-RST
22-000414
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Inclusion Criteria:

  • Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).  
  • Age ≥ 18 years.
  • On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
  • NYHA class II-III symptoms.
  • able to complete a six-minute walk test.


Exclusion Criteria:

  • Patients experiencing syncope or exertional syncope.
  • Patients not experiencing exertional dyspnea.
  • Inability to walk.
  • Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

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

 

 

 

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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Andrea Wahner Hendrickson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306904-P01-RST
22-000456
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Inclusion Criteria:


- Advanced solid tumor

- Measurable disease, per RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate organ function


Exclusion Criteria:


- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the
acute toxicities of previous therapy, except treatment-related alopecia or laboratory
abnormalities otherwise meeting eligibility requirements

- Received prior chemotherapeutic, investigational, or other therapies for the treatment
of cancer within 14 days with small molecule and within 28 days with biologic before
the first dose of TORL-1-23

- Progressive or symptomatic brain metastases

- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,
uncontrolled infection

- History of significant cardiac disease


- History of myelodysplastic syndrome (MDS) or AML

- History of another cancer within 3 years before Day 1 of study treatment, with the
exception of basal or squamous cell carcinoma of the skin that has been definitively
treated. A history of other malignancies with a low risk of recurrence, including
appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate
cancer with a Gleason score less than or equal to 6, are also not excluded

- If female, is pregnant or breastfeeding

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

Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.

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MARANI PRENATAL CONNECTED CARE (M•care) Safety and Effectiveness Study (M•CARE SE Study)

Marani Health M Care Study

Kyle Traynor
Female
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2022-306916-P01-RST
22-000485
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Inclusion Criteria:

  • Able to provide Informed Consent and follow study instructions.
  • 18 years of age or older.
  • Pregnant subjects ≥ 32 weeks’ gestation.
  • Singleton pregnancy.
  • BMI ≥ 15, pre-pregnancy.
  • BMI ≤ 45, pre-pregnancy.
  • Belly circumference ≥ 80 cm and ≤ 135 cm.
    • NOTE: Subjects admitted for induction of labor and subjects being monitored for premature rupture of membranes (PROM) or other inpatient evaluations can be enrolled in the trial.


Exclusion Criteria:

  • Known major fetal malformation or chromosome abnormality.
  • Abdominal medical skin conditions, including surgical incisions, open wounds with or without infections, edema, or irritation.
  • Subjects with implanted electronic devices (pacemakers, defibrillator, etc.).
  • Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
  • Medical or obstetric problem that in investigator's opinion would make the subject incapable of taking part in the study.
  • In the investigator’s opinion, the subject is not likely to be available for the minimum 60 minutes of the monitoring session.
  • History of skin allergies to cosmetics and lotions.
  • Known allergies to silver, nylon, or polyester.
    • NOTE: some people with sensitivity to silver jewelry are sensitive to the impurities in silver alloys and not to silver itself.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

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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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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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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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Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure with preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial (CAMEO SEMA)

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

Barry Borlaug
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306933-H01-RST
22-000522
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Inclusion Criteria:

Subjects are eligible to be randomized in the study only if all of the following inclusion criteria and none of the exclusion criteria apply. To mirror the STEP-HFpEF trials CAMEO-SEMA will utilize essentially the same entry criteria, except for an EF cutoff. CAMEO-SEMA will use an EF value of ≥ 50% (rather than ≥ 45%) to define HFpEF, to harmonize with the recently published universal definition of HFpEF.59.

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Age ≥ 18 years at the time of signing informed consent.
  • BMI ≥ 30.0 kg/m^2.
  • NYHA Class II-IV.
  • LVEF ≥ 50 % within the preceding year.
  • No hospitalizations due to heart failure in the preceding 30 days.
  • At least one of the following:
    • Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise;
    • If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      • Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.
    • Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      •  
      • LA enlargement (LA width ≥ 3.8 cm or LA length ≥  5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm;
      • Ongoing use of diuretic therapy for at least 30 days prior to screening.


Exclusion Criteria:

Cardiovascular-related:

  • Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
  • Systolic blood pressure > 160 mmHg at screening.
  • Planned coronary, carotid or peripheral artery revascularization.
  • Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
    • Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.
  • Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome,  lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice.  This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive.  Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.

Obesity-related:

  • Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
  • A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

Glycemia-related:

  • HbA1c ≥ 6.5% based on latest available value from medical records, no older than 3 months or if unavailable at local measurement at screening.
  • History of type 1 or type 2 diabetes (history of gestational diabetes is allowed).
  • Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.

General health and safety:

  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Presence of acute pancreatitis within the last 180 days prior to screening.
  • History or presence of chronic pancreatitis.
  • End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
  • Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.
  • Receipt of any investigational medicinal product within 30 days before screening.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
  • Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
  • Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
  • The criteria will be assessed at the investigator’s discretion unless otherwise stated.

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

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A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Stephen Ansell
All
18 years to 101 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306939-P01-RST
22-000750
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Inclusion Criteria:

  • Must be ≥ 18 years of age at the time of obtaining informed consent.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 at screening -Must have at least one PET-avid measurable lesion according to Modified Lugano Criteria.
  • Confirmed histological diagnosis of active relapse/refractory cHL.
  • Must have failed at least 2 prior lines of systemic therapy. 
  • No previous treatment with anti-TIM-3.
  • Adequate organ and bone marrow function measured within 7 days prior to first dose.
  • Non-pregnant women and willingness of female patients to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception.


Exclusion Criteria:

  • Unresolved toxicities of ≥ Grade 2 from prior therapy.
  • Any prior ≥ Grade 3 imAE while receiving immunotherapy.
  • Patients with CNS involvement or leptomeningeal disease.
  • History of organ transplantation (e.g., stem cell or solid organ transplant).
  • Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.
  • Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
  • History of arrhythmia which is requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
  • Uncontrolled intercurrent illness.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD.
  • Other invasive malignancy within 2 years prior to screening.
  • Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment.
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention.
  • Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.

 

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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.

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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.

 

Laryngotracheal stenosis
Myhre syndrome, Neuropsychological assessment, Respiratory system
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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.

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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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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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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

Dexamethasone in Total Knee Arthroplasty: What Dose Should We Be Giving Patients Intraoperatively?

Dexamethasone in Total Knee Arthroplasty

Rafael Sierra
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
2022-306989-P01-RST
22-000796
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Primary total knee arthroplasty.
  • Patients staying at least one night in the hospital after surgery.


Exclusion Criteria:

  • Individuals < 18 years.
  • Same day discharge.
  • Revision or partial total knee arthroplasty.
  • Corticosteroid use within 3 months prior to surgery.
  • Inflammatory arthritis
  • Current systemic fungal infection.
  • Renal or liver failure.
  • Prior adverse reaction to corticosteroid.
  • Primary TKA requiring hardware removal.
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10476 / A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers

A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers

Lionel Aurelien Kankeu Fonkoua
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306991-P01-RST
22-000900
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Inclusion Criteria:


- Pathologically confirmed biliary tract cancer, having received at least 1 prior line
of systemic therapy, and received no more than 2 prior lines of therapy in the
metastatic setting (disease recurrence =< 6 months from the last dose of adjuvant
therapy in resected patients will be considered the first line of therapy)

- Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma
(EHC), and gallbladder carcinoma (GBC), but not Ampulla of Vater cancers

- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1

- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) in patients < 18 years
of age, children are excluded from this study

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)

- Absolute neutrophil count >= 1,500/mcL

- Hemoglobin >= 9.0 g/dl

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Patients with
known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
3 x institutional ULN

- Serum creatinine =< 1.5 x institutional ULN OR

- Creatinine clearance > 30 mL/min/1.73 m^2 (calculated by Cockcroft-Gault method) for
patients with creatinine levels above institutional normal

- Albumin >= 3.0 g/dL

- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This
applies only to patients who do not receive therapeutic anticoagulation; patients
receiving therapeutic anticoagulation, such as low-molecular-weight heparin or
warfarin, should be on a stable dose)

- Creatine kinase (CK)/creatine phosphokinase (CPK) < 5 x ULN

- Oxygen saturation >= 92% on room air

- Left ventricular ejection fraction > 50%

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load

- Patients must be willing to undergo 2 sets of core needle biopsies. If possible,
biopsied sites should be different than those used for measurable disease/RECIST
measurements, but this is not mandatory

- Patients must have an estimated life expectancy of greater than 3 months

- Patients must be able to swallow pills

- Patients should not have evidence of retinal pathology on ophthalmologic examination;
or neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular
macular degeneration

- The effects of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) on the developing
human fetus are unknown. For this reason, women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and 5
months after the last dose of atezolizumab. Should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately. Men treated or enrolled on this protocol
must also agree to use adequate contraception prior to the study, for the duration of
study participation, and 5 months (150 days) after completion of atezolizumab,
cobimetinib, and CDX-1127 (varlilumab) administration

- Ability to understand and the willingness to sign a written informed consent document


Exclusion Criteria:


- Patients with prior allogeneic bone marrow transplantation within the past 5 years or
prior solid organ transplantation at any point

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events (other than alopecia or neuropathy) due to agents
administered more than 4 weeks earlier. However, the following therapies are allowed:

- Hormone-replacement therapy or oral contraceptives

- Herbal therapy > 1 week prior to randomization (herbal therapy intended as
anticancer therapy must be discontinued at least 1 week prior to randomization)

- Palliative radiotherapy for bone metastases > 2 weeks prior to randomization

- Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1or other immune checkpoint
inhibitor therapeutic antibodies or pathway-targeting agents. Patients who have only
received previous durvalumab (anti-PD-L1) as part of first line in combination with
gemcitabine and cisplatin (TOPAZ-1 regimen [NCT03875235]) are eligible

- Prior treatment with MEK or ERK inhibitors

- Treatment with any other investigational agent within 4 weeks prior to randomization

- Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to randomization

- Treatment with systemic immunosuppressive medications (including, but not limited to,
prednisone (> 10 mg), cyclophosphamide, tacrolimus, sirolimus, azathioprine,
methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2
weeks prior to randomization.

- Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.

- The use of physiologic doses of systemic corticosteroids and mineralocorticoids
(e.g., fludrocortisone) for patients with orthostatic hypotension or
adrenocortical insufficiency is allowed.

- The use of topical and inhaled corticosteroids are allowed due to low systemic
absorption

- Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of
bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is
allowed

- Presence of therapeutically actionable mutation with approved targeted therapy (e.g.
FGFR fusion patients are eligible for study therapy in the 3rd line setting). Patient
must have received somatic mutation testing (tissue or liquid) prior to enrollment

- Clinically significant ascites (palpable on exam, paracentesis in last 3 months,
and/or symptomatic)

- Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS
metastases are excluded, with the following exceptions:

- Patients with asymptomatic treated CNS metastases may be enrolled, provided all
the criteria listed above are met as well as the following:

- Radiographic demonstration of improvement upon the completion of CNS
directed therapy and no evidence of interim progression between the
completion of CNS directed therapy and the screening radiographic study

- No stereotactic radiation or whole-brain radiation within 28 days prior to
randomization

- Screening CNS radiographic study >= 4 weeks from completion of radiotherapy
and >= 2 weeks from discontinuation of corticosteroids

- Follow-up brain imaging 3 months after central nervous system (CNS)-directed
therapy shows no evidence of progression

- History of malignant bowel obstruction

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
Chinese hamster ovary cell products, chimeric, humanized, or other recombinant human
antibodies or fusion proteins

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to atezolizumab, cobimetinib, or CDX-1127 (varlilumab)

- Patients receiving any medications or substances that are considered moderate to
strong inhibitors or inducers of CYP3A and are not able to switch to an alternative
that minimizes interaction potential will ineligible. Coadministration of cobimetinib
with a strong CYP3A4 inhibitor can increase cobimetinib systemic exposure
significantly (e.g. itraconazole increased serum systemic cobimetinib exposure by 6.7
fold). On the other end, coadministration of cobimetinib with a strong CYP3A inducer
may decrease cobimetinib systemic exposure by more than 80% thus reducing its
efficacy. Because the lists of these agents are constantly changing, it is important
to regularly consult a frequently-updated list such as
http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the
Physicians' Desk Reference may also provide this information. As part of the
enrollment/informed consent procedures, the patient will be counseled on the risk of
interactions with other agents, and what to do if new medications need to be
prescribed or if the patient is considering a new over-the-counter medicine or herbal
product

- Patients on mild inhibitors or inducers of CYP3A are allowed

- Patients with a known clinically significant liver disease, including active viral,
alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.

- Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible.

- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)

- Patients who have received immunosuppressive treatment for systemic autoimmune
disease, including, but not limited to, systemic lupus erythematosus, rheumatoid
arthritis, inflammatory bowel disease, vascular thrombosis associated with
antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple
sclerosis, vasculitis, or glomerulonephritis within the last 2 years.

- Patients with a history autoimmune endocrine disorders on stable doses of
physiologic hormone replacement may be eligible.

- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may
be eligible.

- Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would
be excluded) are permitted provided that they meet the following conditions:

- Patients with psoriasis must have a baseline ophthalmologic exam to rule out
ocular manifestations

- Rash must cover less than 10% of body surface area (BSA)

- Disease is well controlled at baseline and only requiring low potency
topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,
fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)

- No acute exacerbations of underlying condition within the last 12 months
(not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors; high potency or
oral steroids)

- Patients with history Guillain-Barre syndrome or myasthenia gravis at any point
will not be eligible

- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
tomography (CT) scan. History of radiation pneumonitis in the radiation field
(fibrosis) is permitted

- Patients with active tuberculosis (TB) are excluded

- Severe infections within 4 weeks prior to randomization, including, but not limited
to, hospitalization for complications of infection, bacteremia, or severe pneumonia

- Signs or symptoms of infection within 2 weeks prior to randomization

- Received oral or intravenous (IV) antibiotics within 2 weeks prior to randomization

- Patients receiving prophylactic/suppressive antibiotics will not be eligible

- Major surgical procedure within 28 days prior to randomization or anticipation of need
for a major surgical procedure during the course of the study

- Administration of a live, attenuated vaccine within 4 weeks before randomization or
anticipation that such a live, attenuated vaccine will be required during the study
and up to 5 months after the last dose of atezolizumab.

- Influenza vaccination should be given during influenza season only (approximately
October to March). Patients must not receive live, attenuated influenza vaccine
within 4 weeks prior to Randomization or at any time during the study.

- Coronavirus disease 2019 (COVID-19) vaccination is not exclusionary but should be
administered at least 7 days before study start

- Patients with psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because one or more study agents have the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with atezolizumab, cobimetinib, and CDX-1127 (varlilumab), breastfeeding should
be discontinued if the mother is treated with atezolizumab, cobimetinib, and CDX-1127
(varlilumab)

- Patients who are using ethinyl estradiol containing oral contraceptives when
administered concomitantly with cobimetinib, are excluded due to increased risk of
venous thromboembolism

- Patients with a history of clinically significant cardiac dysfunction, including the
following:

- Left ventricular ejection fraction (LVEF) below institutional lower limit of
normal (LLN) or below 50%, whichever is lower

- Current unstable angina

- Current symptomatic congestive heart failure (CHF) of New York Heart Association
class 2 or higher

- Uncontrolled hypertension >= grade 2 (patients with a history hypertension
controlled with anti-hypertensives to =< grade 1 are eligible).

- Uncontrolled arrhythmias

- Myocardial infarction, severe/unstable angina, symptomatic chronic heart failure
(CHF), cerebrovascular accident or transient ischemic attack within the previous
6 months

- History of treatment with cardiotoxic agents

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, 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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Minnesota Regional SCIMS (SCIMS)

Spinal Cord Injury Model Systems for Minnesota Region (SCIMS)

Ronald Reeves
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306996-P01-RST
22-000795
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Inclusion Criteria:

  • Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
  • Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
  •  Admission to the system within one year of injury.
  • Discharge from the System Rehab as:
    • Having completed inpatient acute rehabilitation;
    • Deceased.
  • Signed informed consent and HIPAA authorization forms.
  • Reside in the geographic catchment area of the system at the time of the injury.  Patients may be injured outside of the catchment area.
  • A US citizen or non-US citizen who is expected to stay in the catchment area.


Exclusion Criteria:

  • Must not have previously been treated at another model system for the injury.
    • Ensures that patients are enrolled into the database by only one model system.
  • Must not have completed an organized rehabilitation program prior to the admission to the system.

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

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Location Contacts
Mayo Clinic — Rochester, MN