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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.

3032 Study Matches

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Normative Biomechanical Measures of Reaching in Able-Bodied Adults

Reach Normal Controls

Kristin Zhao
All
20 years to 59 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307103-H01-RST
22-000958
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Inclusion Criteria:


- 20-59 years of age at time of enrollment


Exclusion Criteria:


- Failure to give consent or follow simple commands

- Score of 7 or above on the QuickDASH Outcome Measure

- Score of 5 or above on the Oswestry Low Back Disability Questionnaire

- Score of 76 or below on the Lower Extremity Functional Scale

- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis,
fibromyalgia)

- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional
vertigo)

- Insufficient active range of motion of bilateral shoulders or hips that results in
inability to perform forward or lateral reaching tasks

- Any illness or condition which, based on the research team's assessment, will
compromise the patient's ability to comply with the protocol, patient safety, or the
validity of the data collected during this study

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

Other, Functional reach test
Finding related to ability to reach
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Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)

Cell Saver During Tumor Resection

Matthew Houdek
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307110-H01-RST
22-000975
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Inclusion Criteria:

  • Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.


Exclusion Criteria:

  • Patients undergoing surgery with an expected blood loss of less than 135cc.
  • Provisions for inclusion of minorities: 
    • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

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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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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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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.

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

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

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

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


Exclusion Criteria:

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

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

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

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

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


Exclusion Criteria:

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

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

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

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

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


Exclusion Criteria:

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

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

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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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Pushing the Envelope in Reduction of Hysterectomy Surgical Site Infection (SSI): Studying the role of an Anal Occlusive Dressing (AOD) (AOD and SSI)

Anal Occlusion and SSI Reduction

Tarek Khalife
Female
18 years to 65 years old
This study is NOT accepting healthy volunteers
2022-307005-H01-MAIJ
22-000637
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Inclusion Criteria:

  • Patients subject to a laparoscopic hysterectomy procedure necessitating uterine manipulator use,
  • Age 18-65.


Exclusion Criteria:

  • Patient known to have a vesicovaginal or rectovaginal fistula.
  • Patients who have a documented tape allergy.
  • Patients know to have an active pelvic infection.
  • Patient diagnosed or known to have fecal incontinence.
  • Patients diagnosed or known to have severe external hemorrhoids.
  • Patients with a very short perineal body with < 2cm.
  • Patients who were found to have a disruption in the occlusive dressing seal at the end of the case (blood soilage).
  • Patients necessitating a rectal exam or manipulation as part of the procedure.
  • Patient with visible skin irritation or inflammation around the anal orifice.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Heart Failure (HF) Clinic Biobank

Heart Failure (HF) Clinic Biobank

Horng Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307126-H01-RST
22-000991
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Inclusion Criteria:

  • Patients referred to the Mayo Clinic HF Clinic with a diagnosis of heart failure who have a clinical blood draw scheduled.
  • Adults ≥ 18 years old.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Any history of Hemoglobin less than 9 mg/dL during the past 3 months.
  • Active cancer.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

 

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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence with Natera (cfDNA with Natera)

cfDNA with Natera

Shanda Blackmon
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307127-P01-RST
22-001607
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Inclusion Criteria:

  • Esophageal cancer any stage.
  • Age ≥ 18 years old.
  • Willing and able to provide consent.
  • No prior history of neoadjuvant therapy for the esophageal cancer.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Unable to provide consent.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Cadman Leggett
All
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307142-P01-RST
22-001278
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Inclusion Criteria:
 

  • Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
  • Between the ages of 45 and 80 years, inclusive.
  • Able and willing to provide written informed consent.


Exclusion Criteria:

  • Self-reported pregnancy.
  • Known diagnosis of Colorectal Cancer.
  • History of, or referral for, Inflammatory Bowel Disease.
  • Previous surgery involving the colon or rectum.
  • Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
  • High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
  • Referral for overt, symptomatic gastrointestinal bleeding.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

Device
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Intracardiac Flow Assessment in Cardiac Amyloidosis

Intracardiac Flow Assessment in Cardiac Amyloidosis

Ian Chang
All
40 years and over
This study is NOT accepting healthy volunteers
2022-307150-H01-RST
22-001098
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Inclusion Criteria:


- Subject is clinically stable without cardio-vascular-related hospitalizations within 6
weeks prior to enrollment as assessed by the investigators.

- Subject is able to provide written informed consent and is willing and able to
complete study procedures.

- Currently in sinus rhythm by clinical assessment or documented electrocardiographic
studies.

- Subject and disease characteristics noted by medical record review:

- Healthy control volunteers must also meet the following criteria: Karnofsky
performance scale > 80%; ECOG status 0 or 1.

- ATTRwt cardiac amyloidosis based on meeting all the following criteria: Diagnosis
of amyloidosis within two years prior to study screening; Documentation of
absence of pathogenic TTR mutation; Documentation of absence of plasma cell
dyscrasia, including monoclonal gammopathy of undetermined significance (MGUS) by
laboratory studies including serum free light chain assay and serum or urine
immunofixation; Amyloid deposits in cardiac tissue with TTR protein
identification by mass spectrometry or immuno-histochemistry, OR technetium
(99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake; Evidence of
cardiac involvement by echocardiography with an end-diastolic mean wall thickness
> 12 mm, OR CMR diagnostic of amyloidosis;

- AL with cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; Documented clinical signs and symptoms
consistent with heart failure in the absence of an alternative explanation;
Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR
Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence
of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence of renal failure
or atrial fibrillation OR CMR diagnostic of amyloidosis;

- AL without cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; No documented clinical signs and symptoms
consistent with heart failure from AL; Absence of cardiac involvement as defined
by: Echocardiography with an end-diastolic mean wall thickness < 13 mm if the
subject does not have other causes for increased wall thickness AND NT-proBNP
<333 ng/L if the subject does not have renal failure or atrial fibrillation AND
No CMR diagnostic of amyloidosis if CMR is available prior to screening.


Exclusion Criteria:


- Unable to consent or unable to complete all study procedures.

- Unable to ambulate for 6 minutes (confirmed at study coordinator visit).

- Unable to maintain in supine position for 30 minutes.

- Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator
visit).

- Contraindications for safe CMR scanning (e.g., claustrophobia, cochlear implant,
implanted neural stimulator).

- Presence of implantable cardiac pacemaker, defibrillator or recorder.

- History of intracardiac prosthesis, congenital heart disease, intracardiac shunt,
prior intrathoracic surgery, or procedures to the thoracic aorta or pulmonary
arteries.

- Significant artifact from prior MRI studies.

- Pregnant or breast-feeding women.

- Weight equal to or greater than 155 kg.

- Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70
cm.

- Documented non-sinus rhythm within 6 months prior to screening.

- For healthy controls, the following exclusion criteria apply, confirmed per chart
review and/or patient report:

- History of cardiomyopathy or structural heart disease;

- History of valvular disease of greater than mild severity;

- History of coronary artery disease or coronary heart disease;

- History of cardiac or thoracic surgery.

- History of atrial tachyarrhythmia, ventricular tachyarrhythmia, or symptomatic
bradyarrhythmia;

- Left ventricular hypertrophy or abnormally increased myocardial thickness by
prior echocardiography, cardiac computed tomography, or CMR;

- Acute kidney injury, OR chronic renal disease with glomerular filtration rate <
60 mL/min/1.73m^2 as per medical record review.

- Uncontrolled hypertension of systolic blood pressure > 140 mmHg or diastolic
blood pressure > 90 mmHg as per medical record review;

- Taking two or more anti-hypertensive medications;

- Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c
greater than 7, as per medical record review;

- Taking two or more diabetic medications;

- History of stroke or transient ischemic attack;

- Current cigarette smoker;

- History of peripheral artery disease of aortopathy;

- History of plasma cell dyscrasia or chronic hematologic diagnosis;

- BMI > 35 kg/m^2.

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

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

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Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

Focal Prostate Ablation Utilizing TULSA Profound System

David Woodrum
Male
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307169-P01-RST
22-001336
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Inclusion Criteria:

  • Male patients.
  • Age 45-80 years, with > 10 years life expectancy.
  • Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
  • Stage ≤ T2c, N0, M0.
  • ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
  • PSA ≤ 20 ng/mL reported within 3 months of baseline.
  • Treatment naïve.
  • Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.  


Exclusion Criteria:

  • Inability to undergo MRI or general anaesthesia.
  • Suspected tumour > 30 mm from the prostatic urethra.
  • Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:                
    • Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
  • Unresolved urinary tract infection or prostatitis.
  • History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
  • Artificial urinary sphincter, penile implant or intraprostatic implant.
  • Less than 10 years life expectancy.
  • Patients who are otherwise not deemed candidates for RP.
  • Inability or unwillingness to provide informed consent.
  • History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

 

Procedure/Surgery
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Placental inflammation and function – in vitro analysis

Placenta Study

Sylvie Girard
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
2022-307202-H01-RST
22-000892
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Inclusion Criteria:

  • Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.


Exclusion Criteria:

  • Multiple pregnancy.
  • Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
  • Intrauterine growth retardation or fetal macrosomia.
  • Maternal age under 18 or over 50.
  • Maternal body mass index (BMI) of less than 18 and more than 40.
  • Pregnancy less than 37 weeks of completed gestation.

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

 

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A Post-market Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon (PAS-S)

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Barham Abu Dayyeh
All
22 years to 65 years old
Post Market
This study is NOT accepting healthy volunteers
2022-307203-P01-RST
22-001232
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Inclusion Criteria:

  • Age 22
    •65 years.
  • BMI ≥ 35 and < 40 kg/m^2 or BMI of 30 to 34.9 kg/m^2 with one or more major obesity-related comorbid conditions.
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of obesity (BMI ≥ 30) for at least 2 years.
  • History of failure with non-surgical weight loss methods.
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling.
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow-up visits.
  • Ability to give informed consent.
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.  Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence.  Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester
    •the timing of which will be determined via consultation with the subject’s obstetrician.


Exclusion Criteria:

  • Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
  • Prior open or laparoscopic bariatric surgery.
  • Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
  • Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  • A gastric mass.
  • A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
  • Acid reflux symptoms to any degree that require more than one medication for symptom control.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device.
  • Severe coagulopathy.
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
  • Chronic abdominal pain.
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
  • Hepatic insufficiency or cirrhosis.
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
  • Alcoholism or drug addiction.
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  • Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  • Patients who have BOTH:
    • A previous history of a serotonin syndrome; AND
    • currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
  • Patients who are pregnant or breast-feeding.
  • Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
  • Subjects who have tested positive for H. Pylori, and who have not yet been treated.

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

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T-cell Clonality in Rheumatoid Arthritis (SMRA)

Somatic Mutation in Rheumatoid Arthritis

Jorg Goronzy
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307251-H01-RST
22-001428
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Inclusion Criteria:

  • Diagnosis of seropositive rheumatoid arthritis (either Rheumatoid factor or anti-CCP positive).
  • Age-matched Healthy Controls.


Exclusion Criteria:

  • Chronic active viral infection.
  • History of chemo/radiotherapy.
  • History of cancer.
  • Other autoimmune disease.
  • Pregnancy.

Eligibility last updated 3/23/22. Questions regarding updates should be directed to the study team contact.

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An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Irina Bancos
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307253-P01-RST
22-001433
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Inclusion Criteria:
 

  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
  • According to the Investigator's opinion, will benefit from continuing treatment with relacorilant.


Exclusion Criteria:

  • Premature discontinuation from a relacorilant parent study.
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Has poorly controlled hypertension.
  • Has Stage ≥ 4 renal failure.

Eligibility last updated 2/8/22. Questions regarding updates should be directed to the study team contact.

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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II) (ADI 3)

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Bruce Johnson
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2022-307263-P01-RST
22-001477
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Inclusion Criteria:

  • Adults over the age of 18 and who are willing and able to give informed consent.
  • Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
  • Volunteers of any race, any gender.
  • Range of physiques.


Exclusion Criteria:

  • Injury or skin disturbance in the area of the test device.
  • Pregnant.
  • Currently smokes cigarettes.
  • Has known respiratory conditions such as:
    • Flu;
    • Pneumonia/bronchitis;
    • Shortness of breath/respiratory distress;
    • Respiratory or lung surgery;
    • Emphysema, COPD, lung disease.
  • Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function.
  • Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask).
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Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (OLE for EECSWS)

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Anthony Fine
All
4 years to 16 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-307311-P01-RST
22-001706
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Inclusion Criteria:

  • Written or oral pediatric assent from the subject deemed capable of providing assent and written informed consent from the subject’s parent(s) or legal guardian(s) in accordance with the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and according to local laws and regulations. Informed consent/assent may be done remotely, if allowed per site and remote consenting procedures are in place.
  • Completed 12 weeks of treatment (3 weeks titration and 9 weeks maintenance) in Study NBI-827104-CSWS2010.
  • Subjects of childbearing potential must agree to use highly effective birth control methods consistently while participating in the study until 90 days after the last dose of the study treatment.
  • A female subject of childbearing potential is defined as a subject who has had her first menstrual cycle (ie, menarche). A male subject of childbearing potential is defined as a subject who has reached spermarche.
  • Highly effective methods of birth control for female subjects of childbearing potential are:
    • Combined (estrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception used with an effective nonhormonal method of contraception (eg, barrier contraception used with spermicide);
    • Intrauterine hormone-releasing system used with an effective nonhormonal method of contraception (eg, barrier contraception used with spermicide);
    • Intrauterine device;
    • Bilateral tubal occlusion;
    • Vasectomized partner;
    • True abstinence from sexual intercourse as the preferred lifestyle;
    • Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) is not acceptable.     
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Day 1.
  • The acceptable methods of contraception for male subjects of childbearing potential are:
    • Condom with spermicide (cream, spray, foam, gel, suppository, or polymer film);
    • Vasectomy at least 3 months prior to screening with medically confirmed successful procedure;
    • True abstinence from sexual intercourse as the preferred lifestyle. Note that periodic abstinence is not acceptable.
  • A subject who becomes of childbearing potential during the study will be required to use contraception as described.
  • Willing to comply with all study procedures and restrictions.


Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
  • Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before Day 1 or plans to use such an investigational drug (other than NBI-827104) during the study.
  • It is anticipated that the subject will require treatment with at least 1 of the prohibited concomitant medications or other restrictions during the specified study time frame.
  • Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.
  • The subject or the subject’s parent(s)/caregiver(s) are, in the investigator’s opinion, unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

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Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Wen Wee Ma
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307312-P01-RST
22-001698
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Inclusion Criteria:

  • Male or female and ≥ 18 years-of-age at the time of informed consent.
  • ECOG Performance status 0 or 1.
  • Locally advanced or metastatic resistant or refractory solid tumors.
  • Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
  • Measurable disease as per RECIST v1.1.
  • Ability to swallow and retain oral medications.
  • Acceptable hematologic and organ function at screening.
  • Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
  • Resolution of all toxicities of prior therapy or surgical procedures.
  • Life expectancy ≥ 12 weeks after the start of the treatment.


Exclusion Criteria:

  • Chemotherapy or small molecule antineoplastic agent given within 21 days or < 5 half- lives, whichever is shorter, prior to first dose of study drug.
  • History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
  • Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
  • Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.
  • Uncontrolled, symptomatic brain metastases.
  • Uncontrolled hypertension.
  • Moderate or severe hepatic impairment.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration (BISII)

Effect of Timing of Commencement of BIS Monitoring in Relation to Muscle Relaxant Administration

Matthew Ritter
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307319-H01-RST
22-001485
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Inclusion Criteria:
  

  • Adult patient ≥ 18 years old.
  • Undergoing elective cardiac surgery. 
  • Muscle relaxation administration by rocuronium. 


Exclusion Criteria:
   

  • Patient refusal. 
  • Pediatric patients. 
  • Patients less than 18 years old. 
  • Emergency procedure. 
  • Patients with known or suspected carotid or cerebrovascular disease. 
  • Patients with prior stroke. 
  • Skin condition or anatomy preventing proper sensor placement. 
  • Patients who receive ketamine during the study timeframe. 

Eligibility last updated 2/15/22. Questions regarding updates should be directed to the study team contact.

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EAQ202: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Zhaohui Jin
All
18 years to 39 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307328-P01-RST
22-001776
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Inclusion Criteria:

  • Patient must be ≥ 18 years and ≤ 39 years of age at registration.
  • Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
  • Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
  • Patient must have an ECOG performance status 0-3.
  • Patient must have a life expectancy > 24 months.
  • Patient must be able to complete questionnaires in English.
  • Patient must have internet access through computer, tablet, or smartphone.
  • Patient must have an email address.
  • Patient must have a mobile phone able with text messaging capabilities.
  • Patient must be able to accurately provide self-report data (e.g., per clinical judgment, cognitive function is intact). Patient must be able to provide informed consent.


Exclusion Criteria:

  • Patient must not have a recurrence or second primary cancer.
  • Patient must not have basal cell skin carcinoma.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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Per Oral Endoscopic Myotomy - A Minimally Invasive Treatment Modality for Achalasia (POEM Prospective)

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

Karthik Ravi
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307348-H01-RST
22-001899
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Inclusion Criteria:

  • Patients ≥ 18 years old
  • Patients undergoing POEM for:
    • Achalasia (types I, II, and III);
    • Non-achalasia esophageal motility disorders (e.g., diffuse esophageal spasm).
  • POEM performed at Mayo Clinic by providers in the Division of Gastroenterology or the Division of Thoracic Surgery.


Exclusion Criteria:

  • Patients < 18 years old.
  • Patients with prior POEM performed outside of Mayo Clinic.
  • Prior upper gastrointestinal surgery.
  • No authorization for research participation at Mayo Clinic.
  • Inability to communicate/provide history of symptoms.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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(ECTx) A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations (JSI-1187-01)

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Robert McWilliams
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307388-P01-RST
22-002123
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Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy.
  • Part A (JSI-1187 Monotherapy Dose Escalation):
    • Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions; e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit.
    • Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation):
      • Histologically or cytologically confirmed BRAF V600-mutated locally advanced or metastatic solid tumor, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit.
  • Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
    • Cohort 1: BRAF V600-mutated metastatic melanoma after two prior therapies for metastatic disease, including anti-PD1 therapy, with or without ipilimumab, and BRAF/MEK inhibitor treatment;
    • Cohort 2: BRAF V600-mutated metastatic melanoma after adjuvant therapy for Stage 3 disease followed by one prior therapy for metastatic disease, including anti-PD-1 therapy, with or without ipilimumab or BRAF/MEK inhibitor treatment;
    • Cohort 3: Either BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), or BRAF V600-mutated metastatic solid tumor, after 1 or 2 prior therapies.
  • MAPK mutation tumor status will be established prior to entry based on previous MAPK pathway mutation reports from a CLIA qualified laboratory, or, if a report is not available, the mutation analysis will be performed at Screening on archival tissue or newly biopsied tumor tissue.
  • Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤ 1.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Life expectancy of ≥ 3 months -Subjects with asymptomatic stable, prior or currently treated brain metastases are allowed -Adequate hematologic parameters without ongoing transfusional support:
    • Hemoglobin (Hb) ≥ 9 g/dL -Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L;
    • Platelets ≥ 75 x 10^9 cells/L -Adequate renal and hepatic function;
    • Creatinine ≤ 1.5 times the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula;
    • Total bilirubin ≤ 2 times the (ULN) unless due to Gilbert's disease;
    • ALT/AST ≤ 2.5 times the ULN, or < 5 times the ULN for subjects with liver metastases.
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
  • Ability to provide written informed consent.


Exclusion Criteria:

  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV.
  • QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inhibitors of BCRP are prohibited during study and for 14 days prior to the first dose of study drugs(s).
  • Subjects on dabrafenib (Parts B and C) also are advised to avoid concurrent administration of strong inhibitors of CYP2C8 as these medications may increase the concentration of dabrafenib -History of or current evidence/risk of retinal vein occlusion or central serous retinopathy, or has medically relevant abnormalities identified on screening ophthalmologic examination -Symptomatic central nervous system malignancy or metastasis -Gastrointestinal conditions that could impair absorption of study drug(s).
  • Current hematologic malignancies -Second, active primary solid tumor malignancy that, in the judgement of the investigator or Sponsor medical monitor, may affect the interpretation of results.
  • Prior malignancies, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, Gleason 3+3 prostate cancer and prior malignancies in remission whose likelihood of recurrence is very low, as judged by the Sponsor medical monitor.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment.
  • Other active infection requiring IV antibiotic usage within the last week prior to study treatment.
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Participation within the last 28 days in a clinical trial, or currently enrolled in a clinical trial, involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
  • If female, pregnant, breast-feeding, or planning to become pregnant.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

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Impact of General Anesthesia vs. Moderate Sedation on Cognitive Function After LAOO: An Observational Study

Impact Of General Anesthesia Vs Moderate Sedation On Cognitive Function After LAAO

Mohamad Adnan Alkhouli
All
50 years and over
This study is NOT accepting healthy volunteers
2022-307407-H01-RST
22-002761
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Inclusion Criteria:

  • Men and women ≥ 50 years of age.
  • The patient has met eligibility criteria and is planned to undergo LAAO with the WATCHMAN FLX device as part of clinical care.
  • The patient is able and willing to undergo non-invasive cognitive testing using the Viewmind headset by a trained personal.
  • The patient is able to give informed consent for the procedure.


Exclusion Criteria:

  • The patient unwilling or unable to complete cognitive testing using the specialized virtual reality googles.
  • Primary language is not English.

Eligibility last updated 3/11/22. Questions regarding updates should be directed to the study team contact.

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Artificial Intelligence Enhanced Assessment of Speech Disorders: Prospective Data (NAIP-Speech)

Artificial Intelligence Enhanced Assessment of Speech Disorders

Hugo Botha
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307409-H01-RST
22-002430
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Inclusion Criteria:

  • Adult (18 years or older).
  • Able to provide informed consent (patient or power of attorney).
  • Able to provide samples in English.
  • U.S. based patient.


Exclusion Criteria:

  • Age < 18 years of age.
  • Unable to provide samples in English (i.e., need for interpreter flag in Epic).
  • Nonverbal / No speech.
  • HPP (High Profile Patient) status.
  • International patient.

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

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