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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.

612 Study Matches

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Monitoring Renal Transplant Rejection with Cell Free DNA

A Study to Monitor Renal Transplant Rejection with Cell Free DNA

Ann Moyer
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122677-H01-RST
19-009506
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Inclusion Criteria:

  • Adult patients, 18 years of age or older.
  • Renal transplant recipients undergoing renal biopsy to evaluate for graft function


Exclusion Criteria:
 

  • Patients under 18 years of age.

 

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Mayo Clinic — Rochester, MN

Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery (DoD FAI-2)

Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

Rafael Sierra
All
14 years to 40 years old
This study is NOT accepting healthy volunteers
0000-122678-P01-RST
19-009552
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Inclusion Criteria:

  • Age 14
    •40 years.
  • Skeletally Mature.
  • Failure of 6 weeks of conservative treatment.
  • Primary surgery (Hip Arthroscopic Treatment) a. Surgical treatment of FAI with hip arthroscopy.
  • Tonnis 0 -1 OA, with greater than 2 mm of joint space.
  • Clinical diagnosis of femoroacetabular impingement (FAI) (cam or combined; alpha > 50 degrees).


Exclusion Criteria:

  • Not a surgical candidate.
  • Skeletally Immature.
  • Acetabular Dysplasia (LCEA < 20).
  • Tonnis 2+ OA.
  • Previous ipsilateral hip surgery.
  • Previous major hip trauma (hip fractures, hip dislocations).
  • Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders).
  • Unable to consent due to mental faculty.
  • Pregnant women.
  • Non-English speaking patients.
  • Prisoners or other vulnerable populations.
Hip impingement, Hip pain
Arthroscopy, Femoral acetabular impingement, Hip arthroscopy, Musculoskeletal system
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Biomarker Assessment of Patients with Osteonecrosis of the Femoral Head

A Study to Assess Biomarkers in Patients with Osteonecrosis of the Femoral Head

Rafael Sierra
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122687-H01-RST
19-009613
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Inclusion Criteria:

  • Subjects with target disease ONFH and OA.


Exclusion Criteria:
 

  • ONFH and OA subjects taking the medications statins, steroids, or TZDs will be excluded. 

 

Arthritis, Avascular necrosis, Osteoarthritis, Hip arthritis
Avascular necrosis of the head of femur, Musculoskeletal system, Osteoarthritis of hip
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Mayo Clinic — Rochester, MN

Aneurysm Growth and Enhancement Study - AGES (AGES)

A Study to Analyze Aneurysm Growth and Enhancement

Vance Lehman
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122690-P01-RST
19-009666
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Inclusion Criteria:

  • Patients will be recruited who are undergoing MR Imaging studies as part of their routine clinical care for untreated intracranial aneurysms where no interventional treatment is planned.
  • Consent to research.


Exclusion Criteria:

  • Unable to undergo MRI or have gadolinium (patients are already having these studies as part of routine clinical exam, so don’t foresee this being pertinent).
  • Atypical cause of aneurysm (e.g. infectious, related to atrial myxoma, dissecting, etc.).
  • Unable to remain still enough for diagnostic examinations.
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A Phase 2 Open Label, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Oral Contrast Agent, NX9, for the Delineation of Bowel Anatomy at CT Imaging with and without IV Contrast in Subjects with Cancer or GI Disease Typically Evaluated with CT (MVSS NXT001-19 IBD)

A Study to Evaluate the Safety and Effectiveness of NX9 for CT Imaging in Patients with Cancer or GI Disease

David Bruining
All
18 years to 85 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122693-P01-RST
19-009777
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Inclusion Criteria:

  • Understands the requirements of the study and provides written informed consent.
  • prior to undergoing any study-related procedures.
  • Subject is between the ages of 18 to 85 years old, inclusive.
  • Has had and agrees to submit the results and images of a CT that shows some disease of the bowel or disease adjacent to bowel (e.g., peritoneal disease, carcinomatosis, omental caking or bowel inflammation), such that there is a reasonably high chance that the study CT scan could also show disease and which was:
    • conducted within 6 months prior to study entry;
    • conducted with IV and either positive or neutral oral contrast.
  • Is willing and able to comply with protocol-specified CT scanning and visits to the clinic.
  • Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds.
  • Is able to drink 1.2 liters of fluid within 45 minutes.
  • Has good venous access as determined by the Investigator at screening.
  • Is an outpatient who is able and willing to come to the clinic for study visits.


Exclusion Criteria:

 

  • Has any co-morbidity that the Investigator judges will interfere with their ability to complete the study or undergo a quality CT scan; e.g., high risk of aspiration.
  • Has a history of or is currently suffering from a known gastrointestinal motility disorder; e.g., severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.
  • Has symptoms of a possible current bowel obstruction.
  • Has a moderate to high risk of current bowel perforation.
  • Subject should not schedule a GI diagnostic surgery or hospitalization for any procedure until after the Study follow-up on Day 14 day. However, if at the time of study entry, the subject has pre-planned a surgery or hospitalization, it may be allowed at the discretion of the PI provided it does not take place until after the subject completes the Day 3 ± 2 days visit.
  • Has a contraindication (i.e. allergy) to IV or Oral CT contrast.
  • If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening.
  • Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
Drug, CT of abdomen with contrast
Cancer
CT scan, Digestive system, Disorder of gastrointestinal tract, Malignant neoplasm of gastrointestinal tract, Medical Oncology
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Mayo Clinic — Rochester, MN

Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Michelle Lampman
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122694-H01-RST
19-009784
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Inclusion Criteria:

  • Discharged from hospital in the past 7 days or observation status.
  • Age ≥ 18 years.
  • LACE+ score ≥ 59 and at least two chronic conditions.
  • Index hospitalization with discharge directly to community dwelling (home, assisted living).
  • English speaking.
  • Discharge to home (residential dwelling) or assisted living, as appropriate and determined by the study coordinator.
  • Normal cognitive function. Mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment.
  • Mayo Clinic or Mayo Clinic Health System provider managing the patient’s care (e.g. primary care).  Patient is paneled to a Mayo Clinic MD/NP/PA.
  • Access to and ability to communicate via telephone and/or video (either patient or caregiver).


Exclusion Criteria:

  • Psychiatric hospital admission.
  • Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient’s clinic.
  • Untreated active substance or alcohol abuse.
  • Dementia or moderate to severe cognitive impairment.
  • Discharged to one of the following:
    • Rehabilitation unit;
    • Skilled nursing facility;
    • Assisted living memory unit;
    • Group home;
    • Transitional care unit.
  • Pregnancy.
  • Active treatment for cancer.
  • Receiving dialysis or transplant services.
  • Life expectancy < 6 months or enrolled in hospice or palliative care programs.
  • Patient is unwilling to sign a Release of Information (ROI) – (ROI allows those providing care, internal and external to be actively involved in patient’s care coordination).
  • Patients with active tuberculosis (TB).
  • Violent patient flag noted in Epic.
  • Patient is already enrolled in Remote Patient Monitoring or the Care Transitions Program (CTP), Palliative Care Homebound Program (PCHP), or Primary Care House Calls Program (PCHP), Advanced Care at Home (ACH) Program (NW WI).
  • Recent or active COVID patient (i.e., discharged from COVID admission, active COVID event)
  • Religious Sisterhood living at Mayo Clinic Hospital
    •St. Mary’s Campus or Assisi Heights (Rochester only).
  • Permanently living in a long-term care facility or a memory unit of an assisted living facility.
  • Chronic pain syndrome if chronic pain is the only diagnosis and no chronic medical condition exists.
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The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 for Prevention of Proliferaivie Vitreoretinopathy (n/a)

The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

Raymond Iezzi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122697-P01-RST
19-009841
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Inclusion Criteria:

  • Subject is 18 years or older of any gender or race. 
  • Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury. 
  • Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits. 
  • Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial. 


Exclusion Criteria:

  • History of severe non-proliferative or proliferative diabetic retinopathy. 
  • Other planned eye surgery during the course of the trial. 
  • Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment.
Drug, Other
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Variations in Episcleral Venous Pressure

A Study to Evaluate Variations in Episcleral Venous Pressure

Arthur Sit
All
35 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122699-H01-RST
19-009876
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Inclusion Criteria:

  • ≥ 35 years of age.
  • Either gender.
  • Any self-declared ethno-racial category.
  • Subjects with two healthy eyes with the crystalline lens, without glaucoma or any other clinically significant eye diseases.
  • Open angles in both eyes.
  • Intraocular pressure less than 24 mmHg in either eye.
  • Be able and willing to provide signed informed consent and follow study instructions.
  • Ability to cooperate for the examinations required for study and be able to attend all study visits.
  • Contact lenses removed before the study visit.
  • Best-corrected visual acuity (BCVA) in each eye of 20/50 or better.


Exclusion Criteria:

  • Female subjects who are pregnant or breastfeeding.
  • Narrow angle of < Shaffer grade 2, peripheral synechiae, or peripheral iridotomy in either eye
  • Subjects with a central corneal thickness less than 480 µm or greater than 620 µm in either eye.
  • Chronic or recurrent inflammatory eye diseases.
  • Ocular infection or ocular inflammation in the past 3 months.
  • Ocular trauma other than corneal abrasion within the past 6 months.
  • Clinically significant retinal disease (e.g., diabetic retinopathy, exudative or severe non-exudative macular degeneration).
  • Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity) in either eye.
  • Previous intraocular surgery or laser procedure in either eye.
  • Previous corneal refractive surgeries.
  • Myopia greater than -6.00D, or hyperopia greater than +2.00D.
  • Moderate to severe dry eye in either eye.
  • Serious hypersensitivity to topical anesthetic eye drops.
  • Use of any topical ophthalmic medications other than lubricants and artificial tears within the past 30 days.
  • For healthy subjects cohort: Subjects with a history or presence of chronic generalized systemic disease (such as hypertension, diabetes) that may confound the results of the study.
  • Systolic blood pressure > 145 mmHg or/and diastolic blood pressure > 95 mmHg.
  • For healthy subjects cohort: Subjects who are currently using or have a history of using medications (systemic or topical) that are known to affect IOP or blood pressure within the past 30 days (e.g., systemic/inhaled steroids, α-adrenergic agonists and antagonists, β-adrenergic antagonists, calcium channel blockers, angiotensin converting enzyme [ACE] inhibitors, and  angiotensin II receptor blockers).
  • Subjects with a history or presence of any systemic condition (e.g., heart failure or kidney disease) for which drinking the water volumes proposed in this study could be harmful (for water drinking test visit).
  • For hypertensive subjects cohort: Subjects who are currently using or have a history of using systemic/inhaled steroids within the past 30 days.
  • Use of any products of cannabis (THC or CBD compounds) within the past 30 days.
  • Lack of suitable episcleral vein for EVP measurement.
  •  Subjects who are not fully vaccinated against COVID-19.

Eligibility last updated 12/16/21. Questions regarding updates should be directed to the study team contact.

 

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Electrophysiology of Deep Brain Stimulation (DBS)

A Study to Evaluate Electrophysiology of Deep Brain Stimulation

Kai Miller
All
Not specified
This study is NOT accepting healthy volunteers
0000-122700-H01-RST
19-009878
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Inclusion Criteria:
 

  • Patients undergoing deep brain stimulation (DBS) surgery.


Exclusion Criteria:
 

  • Patients not undergo DBS surgery.
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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant (PRI-VENT FSGS)

A Study to Evaluate Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

Hatem Amer
All
1 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122701-P01-RST
19-009880
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Inclusion Criteria:

  • Age 1-65 years at the time of kidney transplant.
  • Biopsy proven diagnosis of primary FSGS or minimal change disease.
  • History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia).
  • First kidney transplant OR second or third kidney transplant with a history of recurrent FSGS in the first or second transplant
  • The patient (if  ≥ 18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if < 18 years old will be required per local IRB requirements. 
  • Negative urine pregnancy test prior to randomization (for females who are post-menarche). 
  • Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study: 
    • Known genetic cause of FSGS;
    • Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.);
    • Received rituximab within 1 year prior to transplant;
    • Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins;
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
    • Known active bacterial, viral (e.g., HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit;
    • Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer);
    • ANC < 1.5 x 10^3;
    • Hemoglobin: < 8.0 gm/dL;
    • Platelets: < 100,000/mm;
    • AST or ALT > 2.5 x Upper Limit of Normal at the local institution's laboratory;
    • History of drug, alcohol, or chemical abuse within 6 months prior to screening visit;
    • Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential;
    • Concomitant malignancies or previous malignancies; 
    • History of psychiatric disorder that would interfere with normal participation in this protocol;
    • History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease);
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Inability to comply with study and follow-up procedures.


Exclusion Criteria:

  • Known genetic cause of FSGS.
  • Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.).
  • Received rituximab within 1 year prior to transplant.
  • Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
  • Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer)
    • ANC < 1.5 x 10^3;
    • Hemoglobin:  < 8.0 gm/dL;
    • Platelets:  < 100,000/mm;
    • AST or ALT  > 2.5 x Upper Limit of Normal at the local institution’s laboratory.
  • History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
  • Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential.
  • Concomitant malignancies or previous malignancies.
  • History of psychiatric disorder that would interfere with normal participation in this protocol.
  • History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease).
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Inability to comply with study and follow-up procedures.

 

Drug, Procedure/Surgery
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HELIOS-B: A Phase 3, Randomized, Doubleblind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

A Study to Evaluate the Effectiveness and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy

Martha Grogan
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122704-P01-RST
19-009925
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Inclusion Criteria:

  • Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy:
    • Hereditary ATTR (hATTR) amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
    • Documentation of a TTR pathogenic mutation consistent with hATTR amyloidosis;
    • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm (based on central echocardiogram reading at Screening);
    • Amyloid deposits in cardiac or noncardiac tissue (e.g., fat pad aspirate, salivary gland, median nerve connective sheath) confirmed by Congo Red (or equivalent) staining OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99mTc-pyrophosphate [PYP-Tc] or 99Tchydroxymethylene diphosphonate [HMDP]) with Grade 2 or 3 cardiac uptake, if monoclonal gammopathy of undetermined significance (MGUS) has been excluded;
    • If the patient has evidence of a MGUS based on serum and urine protein electrophoresis and serum free light chains,  documentation of TTR protein in tissue with immunohistochemistry or mass spectrometry is required.
    • Wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
      • Documentation of absence of pathogenic TTR mutation;
      • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12mm (based on central echocardiogram reading at Screening);
      • Amyloid deposits in cardiac tissue with TTR protein identification by IHC, mass spectrometry, OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99mTc-pyrophosphate [PYP-Tc], or 99Tchydroxymethylene diphosphonate [HMDP]) with Grade 2 or 3 cardiac uptake, if MGUS has been excluded;
      • If the patient has evidence of a MGUS based on serum and urine protein electrophoresis and serum free light chains, the following is required: documentation of TTR protein in cardiac tissue with immunohistochemistry or mass spectrometry OR documentation of TTR protein in noncardiac tissue (e.g., fat pad aspirate, salivary gland, median nerve connective sheath) with immunohistochemistry or mass spectrometry; AND Grade 2 or 3 cardiac uptake on technetium scintigraphy.
  • Medical history of HF with at least 1 prior hospitalization for HF (not due to arrhythmia or a conduction system disturbance treated with a permanent pacemaker) OR clinical evidence of HF (with or without hospitalization) manifested by signs and symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that currently requires treatment with a diuretic.
  • Patient meets one of the following criteria: a. Tafamidis-naïve and not actively planning to commence treatment with tafamidis during the first 12 months following randomization.
    • Note: in addition to patients who have never taken tafamidis, those who have previously been on tafamidis and have not received any tafamidis for at least 30 days before the Screening Visit will be considered tafamidis-naïve for purposes of this study); or
    • On tafamidis.  Note: must be on-label use of commercial tafamidis per an approved cardiomyopathy indication and dose in the country of use.
  • Patient is clinically stable, with no CV-related hospitalizations within 6 weeks prior to randomization, as assessed by the Investigator.
  • Screening NT-proBNP > 300 ng/L and 600 ng/L and < 8500 ng/L.
  • Able to complete ≥ 150 meters on the 6-MWT at Screening.
  • Have a Karnofsky performance status of ≥ 60%


Exclusion Criteria:

  • Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis.
  • NYHA Class IV heart failure; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3 (defined as NT-proBNP > 3000 ng/L and eGFR < 45 ml/min).[Gillmore 2018].
  • Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV (requires cane or stick to walk due to polyneuropathy, or is wheelchair bound) at the Screening visit.
  • Has any of the following laboratory parameter assessments at Screening:
    • AST or ALT levels > 2.0 × ULN;
    • Total bilirubin > 2.0 × ULN;
    • International normalized ratio (INR) > 1.5 (unless patients were on anticoagulant therapy in which case excluded if INR ˃ 3.5).
  • Has eGFR < 30 mL/min/1.73 m^2 (using the modification of diet in renal disease [MDRD] formula) at Screening.
  • Has known human immunodeficiency virus infection; or evidence of current or chronic hepatitis C virus or hepatitis B virus infection.
  • Tafamidis-naïve patients for whom the Investigator actively plans or anticipates commencing treatment with tafamidis either during the Screening Period or the first 12 months following randomization, taking into consideration clinical status, patient preference and/or commercial availability of tafamidis.
  • Received prior TTR-lowering treatment (including revusiran, patisiran or inotersen) or participated in a gene therapy trial for hATTR amyloidosis.
  • Is currently taking diflunisal; if previously on this agent, must have at least a 30-day wash-out prior to dosing (Day 1).
  • Is currently taking doxycycline, ursodeoxycholic acid, or tauroursodeoxycholic acid; if previously on any of these agents, must have completed a 30-day wash-out prior to dosing (Day 1).
  • Unwilling to avoid any concurrent treatment with diflunisal, ursodeoxycholic acid/tauroursodeoxycholate/doxycycline, or TTR lowering agents (e.g., patisiran, inotersen)
  • Current or future participation in another investigational device or drug study, scheduled to occur during this study, or has received an investigational agent or device within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). In the case of investigational TTR stabilizer drugs, washout for 3 months prior to dosing (Day 1) is required; this does not apply to patients who are on tafamidis at baseline.
  • Requires treatment with or is unwilling to avoid any concurrent treatment with nondihydropyridine calcium channel blockers (e.g., verapamil, diltiazem).
  • 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). In the case of investigational TTR stabilizer drugs, washout for 3 months prior to dosing (Day 1) is required; this does not apply to patients who are on tafamidis at baseline.
  • Requires treatment with or is unwilling to avoid any concurrent treatment with nondihydropyridine calcium channel blockers (e.g., verapamil, diltiazem).
  • Other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzymes and ECG changes) that the Investigator feels is a significant contributor or the predominant cause of the patient’s heart failure.
  • Unstable congestive heart failure (CHF) (including patients who require adjustment of existing diuretics or addition of new diuretics at time of Screening for purposes of achieving optimal management of CHF).
  • Had acute coronary syndrome or unstable angina within the past 3 months.
  • Has history of sustained ventricular tachycardia or aborted ventricular fibrillation.
  • Has history of atrioventricular nodal or sinoatrial nodal dysfunction for which a pacemaker is indicated but will not be placed.
  • Has persistent elevation of systolic (˃ 170 mmHg) or diastolic (˃ 100 mmHg) blood pressure that is considered uncontrolled by physician.
  • Has untreated hypo- or hyperthyroidism.
  • Has an active infection requiring systemic antiviral, antiparasitic or antimicrobial therapy that will not be completed prior to dosing (Day 1).
  • Prior or anticipated (during the first 12 months after randomization) heart, liver or other organ transplant or implantation of left-ventricular assist device.
  • History of multiple drug allergies or history of allergic reaction to any component of or excipient in the study drug.
  • History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study drug administration or evaluation of local tolerability.
  • Has other medical conditions or comorbidities (e.g., malignancy, neuropsychiatric disorder etc…) which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
  • Is not willing to comply with the contraceptive requirements during the study period.
  • Female patient is pregnant, planning a pregnancy, or breast-feeding.
  • Unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol intake of > 2 units/day is excluded during the study (unit: 1 glass of wine [approximately 125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL]).
  • History of alcohol abuse, within the last 12 months before Screening, in the opinion of the Investigator.
  • History of illicit drug abuse within the past 5 years that in the opinion of the Investigator would interfere with compliance with study procedures or follow-up visits.
Drug, Other
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A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM) (ATTR CM)

A Study to Evaluate the Effectiveness and Safety of AKCEA-TTR-LRx in Patients with ATTR CM

Daniel Borgeson
All
18 years to 90 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122706-P01-RST
19-009942
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Inclusion Criteria:

  • Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
  • 18 to 90 years of age (inclusive).
  • Females: must be non-pregnant and non-lactating and either:
    • surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy);
    • post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and folliclestimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved);
    • abstinent*; or
    • if of child-bearing potential and engaged in sexual relations, agree to use 1 highly effective contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of Study Drug (ION‑682884 or placebo).
  • Males must be surgically sterile or abstinent*; if engaged in sexual relations with a female of child-bearing potential, the patient must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of Study Drug.

*Abstinence is only acceptable as true abstinence; i.e., when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception.

  • Willing to be genetically tested for mutations in the TTR gene during screening, if it was not done before.
  • Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99mTc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed.
  • End-diastolic interventricular septum thickness of > 12 mm on Screening echocardiogram.
  • Medical history of HF secondary to hereditary or wild-type ATTR-CM with at least:
    • 1 prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker/ICD (implantable cardioverter defibrillator) placement; OR
    • symptoms and signs of volume overload or elevated intracardiac pressure that either requires or required treatment with diuretics for clinical stabilization.
  • Screening N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL by central lab. For patients in atrial fibrillation at Screening the eligibility NT-proBNP value is ≥ 1200 pg/mL.
  • New York Heart Association (NYHA) class I-III.
  • 6MWT ≥ 150 meters.
  • If on medical treatment for HF, stable medication regimen for at least 2 weeks prior to randomization.
  • Willingness to adhere to vitamin A supplementation per protocol.


Exclusion Criteria:

  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening.
  • Hospitalization or urgent visit to emergency department/emergency room (ED/ER) for worsening of HF within 4 weeks prior to or during Screening.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 100 mmHg).
  • Uncontrolled clinically significant cardiac arrhythmia, per Investigator’s assessment (e.g., no pacemaker, although indicated).
  • Severe, uncorrected, cardiac valvular disease.
  • Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
  • Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a patient unsuitable for inclusion:
    • Alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 2.0 × upper limit of normal (ULN);
    • Total bilirubin ≥ 1.5 × ULN (patients with total bilirubin ≥ 1.5 × ULN may be allowed on study if indirect bilirubin only is elevated, ALT/AST is not greater than the ULN, and known to have Gilbert’s disease);
    • Platelets < lower limit of normal (LLN; central laboratory);
    • Urine protein creatinine ratio (UPCR) ≥ 750 mg/g. In the event of UPCR above this threshold, ineligibility may be confirmed by a repeat random spot UPCR ≥ 750 mg/g;
    • Positive test (including trace) for blood on urinalysis. In the event of a positive test ineligibility may be confirmed with urine microscopy showing > 5 red blood cells per high power field in women, this exclusion criterion must be assessed outside of menstrual period;
    • Estimated glomerular filtration rate (eGFR) < 30 mL /min/1.73 m^2 at Screening [CKD-EPI formula; (Levey et al. 2009)]. If the eGFR is thought to be underestimated, the CKD-EPI creatinine-cystatin C equation can be used for confirmation (Inker et al. 2012);
    • Abnormal thyroid function tests with clinical significance per Investigator judgement;
    • Serum retinol level at Screening < LLN (this criterion does not apply to hATTR-CM patients with mutation at the position 84 [e.g., Ile84Ser]);
    • Hemoglobin A1c (HbA1c) > 9.5%.
  • Monoclonal gammopathy of undetermined significance (MGUS) and/or immunoglobulin free light chain ratio < 0.26 and/or > 1.65, unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy.
  • Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1.
  • Known history of or positive test for human immunodeficiency virus (HIV), (as evidenced by positive tests for HIV antibody and HIV RNA), hepatitis C (as evidenced by positive tests for HCV antibody and HCV RNA) or hepatitis B (as evidenced by a positive test for hepatitis B surface antigen).
  • History of bleeding, diathesis or coagulopathy (e.g., liver cirrhosis, hematologic malignancy, antiphospholipid antibody syndrome, congenital disorders such as hemophilia A, B, and Von Willebrand disease).
  • If receiving oral anticoagulants (except vitamin K antagonists), the dose must have been stable for 4 weeks prior to the first dose of Study Drug and regular monitoring must be performed, per clinical practice during the study. If the patient is receiving vitamin K antagonists (e.g., warfarin) INR should be in therapeutic range, as established by the Investigator, for 4 weeks prior to the first dose.
  • Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. Patients with a history of other malignancies who have been treated with curative intent and without recurrence within 5 years may also be eligible per Investigator judgment 14. Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization.
  • Karnofsky performance status of ≤ 50%.
  • Contraindication for immunosuppressive therapy, per Investigator’s discretion.
  • Known Light chain/Primary Amyloidosis (AL).
  • Known leptomeningeal amyloidosis.
  • Known history of multiple myeloma.
  • Treatment with another investigational drug and/or biological agent within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer.
  • Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or RNA therapeutic (including siRNA).
  • Current treatment with diflunisal, doxycycline, non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Patients receiving any of these agents must respect a wash-out period of 14 days before randomization.
  • Unwillingness or inability to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
  • Other physical, social, or psychological conditions including illicit drug or alcohol use, which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
Drug therapy, Drug, Other, Behavioral
Amyloidosis
Eplontersen [USAN], Hematopoietic system, Transthyretin related familial amyloid cardiomyopathy
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Evaluation of DDP3 as a Prognostic Factor for Cardiogenic Shock in Patients with STEMI

A Study to Evaluate DDP3 as a Predictor of Cardiogenic Shock in Patients Presenting with Cardiac Symptoms

Vlad Vasile
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122708-P01-RST
19-009952
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Inclusion Criteria:

  • Adults more than 18 years old.
  • Adults presenting with ST elevation myocardial infarction.
  • Able to consent.


Exclusion Criteria:

  • Unable to provide consent.

 

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Progenitor Cells for Patients with Degenerative Lung Disease

A Study to Evaluate Progenitor Cells for Patients with Degenerative Lung Disease

Dennis Wigle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122709-H01-RST
19-009956
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Inclusion Criteria:

  • Adults >18 years old.
  • Adults with chronic lung disease undergoing lung resection surgery.


Exclusion Criteria:
 

  • Patients < 18 years old.

 

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E-cigarette or Vaping Associated Lung Injury (EVALI): Imaging in Non-urgent, Symptomatic and Asymptomatic Individuals

A Study to Evaluate Imaging in Non-urgent, Symptomatic and Asymptomatic Individuals with E-cigarette or Vaping Lung Injury

Rebecca Lindell
All
18 years to 45 years old
This study is NOT accepting healthy volunteers
0000-122710-H01-RST
19-009962
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Inclusion Criteria:

  • >18 and <45 years of age.
  • Asymptomatic individuals who have vaped at least once a week for the past 6 months or longer OR individuals with non-urgent symptoms possibly related to vaping whose symptom onset occurred after at least weekly vaping use for 3 months or longer (non-urgent is defined as following: in the opinion of the investigator or primary care physician, the patient does not require urgent/emergent medical care for symptom management).
  • Current vapers or those vapers who have quit within the past 30 days.
  • If subject is referred by a physician as a symptomatic patient, his or her health history, medications, review of symptoms, and physical exam are available in Epic EMR and would have been updated within the past 30 days.
  • Subject is a never smoker
    •defined as having used less than 100 cigarettes in their lifetime.
  • Able to fully participate in all aspects of the study.
  • Able to understand and sign the consent.
  • Mayo Clinic patient with a primary care physician who can be contacted if medical attention to CT findings is needed.

Exclusion criteria

  • Smoked one or more cigarettes within the past 30 days.
  • With the exception of asthma, has a known medical condition that causes or can cause lung findings, including but not limited to heart disease, liver or kidney failure, amyloidosis, cancer (excluding non-melanoma skin cancer), HIV, immunosuppression, bleeding disorders, cystic fibrosis, emphysema, or any interstitial lung disease.
  • An upper respiratory infection (includes nasal congestion with cough), pneumonia or influenza within the past 30 days.
  • Chronic respiratory symptoms prior to the start of vaping.
  • With the exception of vaping marijuana and THC products, participant must have NO  history of IV drug abuse, not used non-THC illicit drugs within the past 6 months, and not smoked marijuana within the last 3 months.
  • Has an unstable or urgent medical condition as determined by the physician investigator.
  • Expired air carbon monoxide > 8 ppm.

Eligibility last updated 9/28/22. Questions regarding updates should be directed to the study team contact.

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Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening BLUE-C

A Study to Validate An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test for Colorectal Cancer Screening

John Kisiel
All
40 years and over
This study is NOT accepting healthy volunteers
0000-122724-P01-RST
19-010086
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Inclusion Criteria:

  • Subject is male or female, ≥ 40 years of age at the time of enrollment. 
  • Subject presents for a screening colonoscopy per standard of care. 
  • Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 
  • Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the Study Investigator.


Exclusion Criteria:
 

  • Subject has a personal history of CRC or advanced precancerous lesions.
  • Subject has a diagnosis or medical / family history of any of the following conditions, including:
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner’s syndrome);
    • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome");
    • Other hereditary cancer syndromes including but are not limited to Peutz–Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail’s) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
  • Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn’s disease.
  • Subject has a diagnosis of Cronkhite-Canada Syndrome.
  • Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
  • Subject has undergone a colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
  • Subject has had overt rectal bleeding within the previous 30 days.
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Cancer, Colon cancer, Rectal cancer
Digestive system, Malignant neoplasm of colon and/or rectum, Medical Oncology, Stool DNA test
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The Assessment of Carotid Blood Velocity Using Continuous Wave Doppler during Lower Body Negative Pressure

A Study to Assess Carotid Blood Velocity Using Continuous Wave Doppler during Lower Body Negative Pressure

Bruce Johnson
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122730-P01-RST
19-010136
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Inclusion Criteria:

  • 15 healthy individuals aged ≥ 18 years.
  • No history of cardiovascular diseases.
  • Current non-smokers.
  • All subjects will be informed about the study and consented prior to participation


Exclusion Criteria:

  • Subjects with a history of more significant hypotension (SBP < 90mmHg).
  • Subjects who are morbidly obese (BMI > 38).

 

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An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema (APeX-S)

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

Thanai Pongdee
All
12 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122737-P01-RST
19-010175
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Inclusion Criteria:
 

  • Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks. 
  • Access to appropriate medication for treatment of acute attacks.
  • Acceptable effective contraception.
  • Written informed consent.


Exclusion Criteria:
 

  • Pregnancy or breast-feeding.
  • Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study.
  • Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study.
  • Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study.
  • Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology.
  • Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator.
  • Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit).
Drug
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Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia (PATH-HHT)

A Study to Evaluate Pomalidomide to Treat Bleeding in Hereditary Hemorrhagic Telangiectasia (HHT)

Vivek Iyer
All
18 years to 99 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122740-P01-RST
19-010200
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Inclusion Criteria:


1. A clinical diagnosis of HHT as defined by the Curacao criteria

2. Age > 18 years

3. Platelet count ≥ 100,000/µl

4. WBC ≥ 2,500/µl

5. INR ≤ 1.4 and normal ± 2 sec activated partial thromboplastin time (aPTT) by local
laboratory criteria (except for patients on a stable dose of warfarin or direct oral
anticoagulants)

6. Epistaxis severity score ≥ 3 measured over the preceding three months, measured at the
screening visit

7. A requirement for anemia, as determined by local laboratory normal ranges, and/or
parenteral infusion of at least 250 mg of iron or transfusion of 1 unit of blood over
the 24 weeks preceding the screening visit

8. Females of childbearing potential (FCBP) must adhere to the scheduled pregnancy
testing (once very two weeks) as required in the POMALYST REMS program. FCBP must a
negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10
•14
days prior to and again within 24 hours of prescribing pomalidomide and must either
commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
methods of birth control, one highly effective method and one additional effective
method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. Men
must agree to use a latex condom during sexual contact with a FCBP even if they have
had a vasectomy.

9. Ability to understand and sign informed consent

10. All study participants must agree to be registered into the FDA mandated POMALYST REMS
program, and be willing and able to comply with the requirements of the POMALYST REMS
program


Exclusion Criteria:


1. Women currently breast feeding

2. Renal insufficiency, serum creatinine > 2.0 mg/dl

3. Hepatic insufficiency, bilirubin > 2.0 (or >4.0 in the setting of a prior clinical or
genetic diagnosis of Gilbert's syndrome) or transaminases > 3.0x normal

4. Prior treatment with thalidomide or other imid drugs within previous 6 months

5. Prior treatment with bevacizumab (systemic or nasal) within previous 6 weeks

6. Prior treatment with pazopanib within previous 6 weeks

7. The use of octreotide or estrogens within the previous month

8. History of prior unprovoked thromboembolism confirmed by venous ultrasound or other
imaging modalities

9. Peripheral neuropathy, confirmed by neurologic consultation

10. Known underlying hypoproliferative anemia (i.e. myelodysplasia, aplastic anemia)

11. Currently enrolled in other interventional trials

12. Known hypersensitivity to thalidomide or lenalidomide.

13. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

14. Known SMAD-4 mutation, unless there has been a colonoscopy with normal (negative)
results, or in which the patient has had no more than 5 small (in the opinion of the
gastroenterologist) colonic polyps completely removed within the preceding 18 months

15. Anything that in the investigator's opinion is likely to interfere with completion of
the study

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

Drug, Other, Drug therapy, Epistaxis care, Intravenous infusion of iron, Transfusion of blood product
Hereditary hemorrhagic telangiectasia
3-Aminophthalimidoglutarimide, Bleeding from nose, Blood transfusion, Circulatory system, Osler hemorrhagic telangiectasia syndrome, pomalidomide
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Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis

A Study to Create a Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis

Annalise Larson
All
8 years to 17 years old
This study is NOT accepting healthy volunteers
0000-122743-P01-MPMC
19-010211
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Inclusion Criteria:
  (may be modified based on the approved device HDE indications)

  • ≥ 8 years old on date of surgery.
  • Male or female.
  • Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement and a non-fusion surgery is scheduled within 4 months.
  • Thoracic or lumbar primary curves.
  • Preop Cobb Angle ≥ 30° and ≤ 65°.
  • Skeletally immature: Risser (< 5) and Sanders (< 8).
  • Spina bifida Oculta is permitted.
  • Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
  • Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
  • Failed or intolerant to bracing.
  • No prior spine surgery.


Exclusion Criteria:

  • Presence of any systemic infection, local infection, or skin compromise at the surgical site.
  • Skeletally mature: > 7 Sanders.
  • Prior spinal surgery.
  • Documented poor bone quality, defined as a T-score -1.5 or less (If DEXA collected as routine care).
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient’s unwillingness or inability to cooperate with postoperative care instructions.
  • MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Neuromuscular or other serious co-morbidities.
  • Thoracogenic or cardiogenic scoliosis.
  • Associated syndrome or developmental delay.
  • Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent.
  • Unwillingness to sign Informed Consent Form and participate in study procedure.
  • Subjects who are pregnant at the time of enrollment.
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Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis

A Study to Create a Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis

Annalise Larson
All
8 years to 17 years old
This study is NOT accepting healthy volunteers
0000-122743-P01-RST
19-010211
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Inclusion Criteria:
  (may be modified based on the approved device HDE indications)

  • ≥ 8 years old on date of surgery.
  • Male or female.
  • Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement and a non-fusion surgery is scheduled within 4 months.
  • Thoracic or lumbar primary curves.
  • Preop Cobb Angle ≥ 30° and ≤ 65°.
  • Skeletally immature: Risser (< 5) and Sanders (< 8).
  • Spina bifida Oculta is permitted.
  • Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
  • Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
  • Failed or intolerant to bracing.
  • No prior spine surgery.


Exclusion Criteria:

  • Presence of any systemic infection, local infection, or skin compromise at the surgical site.
  • Skeletally mature: > 7 Sanders.
  • Prior spinal surgery.
  • Documented poor bone quality, defined as a T-score -1.5 or less (If DEXA collected as routine care).
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient’s unwillingness or inability to cooperate with postoperative care instructions.
  • MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Neuromuscular or other serious co-morbidities.
  • Thoracogenic or cardiogenic scoliosis.
  • Associated syndrome or developmental delay.
  • Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent.
  • Unwillingness to sign Informed Consent Form and participate in study procedure.
  • Subjects who are pregnant at the time of enrollment.
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Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial

A Study to Evaluate the Effectiveness of Intralesional Vitamin D Injections for Treatment of Common Warts

Stephen Merry
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122745-P01-RST
19-010219
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Inclusion Criteria:

  • Adult Employee and Community Health (ECH) patients seen at the Mayo Clinic Rochester practices.
  • Patients suffering from one or more cutaneous warts as diagnosed by the examining physician at baseline visit on typical diagnostic characteristics.
  • Able to provide consent.
  • Both recalcitrant and non-recalcitrant warts will be included.


Exclusion Criteria:

  • Patients with prior use of home or office-based destructive treatments for this wart(s) in the last 1 month with SA or cryotherapy.
  • Immunoadjuvant therapy for warts in the last 4 months (e.g Candida).
  • History of vitamin D injection of warts ever.
  • High-dose vitamin D supplementation (> 4,000 IU daily or equivalent) in the preceding 3 months.
  • Pregnancy or lactation.
  • Facial or genital warts.
  • Lesions not felt by the examining clinician to be a wart (e.g., corns or calluses).
  • Immunosuppression (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit).
  • Allergy to sesame oil.
Drug, Other, Injection of vitamin D, Intralesional injection of skin
Common warts
Integumentary system, Verruca vulgaris, vitamin D, Vitamin D
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Using a Wearable Sensor as an Alternative to Marker-based Motion Capture for Studying Baseball Pitching

A Study to Evaluate A Wearable Sensor to Study Baseball Pitching

Christopher Camp
Male
15 years to 30 years old
This study is NOT accepting healthy volunteers
0000-122750-H01-RST
19-010255
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Inclusion Criteria:

  • Age 15-30 years, inclusive.
  • Male gender.
  • Active participation in competitive baseball as a pitcher.Should be competing at the high school or collegiate level.
  • No current musculoskeletal complaints for which the subject is being treated.
  • Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
  • Willingness to participate in the study


Exclusion Criteria:
 

  • Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
  • History of fracture, dislocation, subluxation, or separation affecting the cervical spine, thoracic spine, rib cage, elbow, or either shoulder girdle.
  • History of rotator cuff injury, elbow injury, or shoulder instability for which the subject has been evaluated and/or treated in the past 12 months.
  • History of dominant side shoulder or elbow surgery.
  • Known neurological, visual, or vestibular disease affecting balance or coordination
  • Congenital deformity of the neck, upper extremity, or lower extremity.
  • Congenital or acquired scoliosis or significant thoracic kyphosis (> 30 degrees).
  • History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

 

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Surveillance HeartCare® Outcomes Registry (SHORE) (SHORE)

Surveillance HeartCare® Outcomes Registry

Alfredo Clavell
All
15 years and over
This study is NOT accepting healthy volunteers
0000-122751-P01-RST
19-010258
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Inclusion Criteria:

  • Patients who are ≥ 15 years of age at the time of blood draw.
  • Received a heart transplant (primary or repeat).
  • Patients who have HeartCare initiated within 3 months post-transplant.


Exclusion Criteria:

  • Patients who are pregnant at the time of blood draw.
Transplant disorder, Transplant-associated infection
Heart transplant, Transplanted heart present
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The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. (NODE-303)

Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

Peter Noseworthy
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122822-P01-RST
19-010285
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Inclusion Criteria:

  • Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT that includes the AV node as a critical part of reentrant circuit. 
  • Is at least 18 years of age.
  • Signed NODE-303 written informed consent.
  • Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial and must be willing to discontinue from the study should they become or plan to become pregnant. Postmenopausal females are defined as having amenorrhea for at least 12 months prior to Screening without an alternative medical cause.
  • Willing and able to comply with study procedures.


Exclusion Criteria:

  • Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
  • History of allergic reaction to verapamil.
  • Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is oral amiodarone which must be stopped 30 days before enrollment.
  • History or evidence of ventricular pre-excitation; e.g., delta waves, Wolff-Parkinson-White syndrome.
  • History or evidence of a second- or third-degree AV block.
  • History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia).
  • Symptoms of congestive heart failure New York Heart Association Class II to IV.
  • SBP < 90 mmHg at Screening, Baseline or any Follow-up Visit.
  • Severe symptoms of hypotension experienced during PSVT episodes.
  • Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient’s capacity to follow the study procedures.
  • History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope.
  • Is pregnant or breastfeeding.
  • Previously enrolled in a clinical trial for etripamil and received study drug or participation in any clinical trial for other investigational products or medical devices within 30 days of Screening.
  • History of ACS or stroke within 6 months of Screening.
  • Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
    • < 60mL/min/1.73m^2 for patients < 60 years of age;
    • < 40mL/min/1.73m^2 for patients ≥ 60 and < 70 years of age;
    • < 35mL/min/1.73m^2 for patients ≥ 70 years of age.
Drug
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Mayo Clinic — Rochester, MN

Clinical Protocol for Emergency Department Treatment Study Jaspr Randomized Controlled Trial (Jaspr)

A Study to Evaluate Jaspr Application Compared to Care As Usual (CAU) in Emergency Department

Gabrielle Melin
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122825-P01-RST
19-010319
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Inclusion Criteria:

  • Currently in the ED seeking treatment for suicidal behavior.
  • Medically and clinically stable, as deemed by ED medical personnel/patient’s care team.
  • Access to a computer or other device (smartphone, tablet) with Internet connection.
  • Currently has and regularly uses an Apple or Android smartphone.
  • Stable address and housing for the last 30 days.

Exclusion Criteria:

  • Acutely psychotic, severely agitated, and patients with significant intoxication or other impairment (as deemed by medical providers) that may interfere with providing consent and meaningful feedback (as determined by their care team).
  • No access or way to access phone or computer (or other device) with Internet connection.
  • homeless or unstable housing in the past 30 days.
  • Severely agitated patients are those who are perceived by medical personnel as highly distressed and likely to become more agitated (e.g., yelling, throwing objects, engaging in self-harming behaviors) and/or distressed if approached by medical personnel and/or research staff about research-related activities, from inquiring about their interest to participate and obtaining informed consent to providing feedback to researchers.
Behavioral, Other, Assessment for suicidality, Education about suicide prevention smartphone application, Emergency treatment
Suicidal behavior
Suicidal behavior
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A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II) (E4Comfort)

A Study to Evaluate Estetrol to Treat Moderate-to-Severe Vasomotor Symptoms in Postmenopausal Women

Ekta Kapoor
Female
40 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122827-P01-RST
19-010338
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Inclusion Criteria:

  • Signed and dated written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, after the nature of the trial has been explained according to local regulatory requirements.
  • Females ≥ 40 up to ≤ 65 years of age at randomization.
  • For hysterectomized subjects: documented hysterectomy must have occurred at least 6 weeks prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed).
  • For non-hysterectomized subjects: uterus with bi-layer endometrial thickness ≤ 4 mm on TVUS (Amendment 3, 08 October 2019 and Amendment 4, 03 February 2020).
  • For non-hysterectomized subjects: endometrial biopsy taken during screening that reveals no abnormal results; i.e., presence of hyperplasia (simple or complex, with or without atypia), presence of carcinoma, and presence of disordered proliferative findings. The screening biopsy should have sufficient endometrial tissue for diagnosis. Biopsies without tissue or with insufficient tissue may be repeated once.
  • Seeking treatment for relief of VMS associated with menopause:
    • For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period;
    • For the Safety Study part: at least 1 moderate to severe VMS per week.
  • Body mass index ≥ 18.0 kg/m² to ≤ 38.0 kg/m².
  • A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening.*
  • Post-menopausal status defined as any of the following:
  • For non-hysterectomized subjects:
    • or at least 6 weeks postsurgical bilateral oophorectomy;
    • or at least 6 months of spontaneous amenorrhea with serum FSH > 40 mIU /mL and E2 < 20 pg/mL (value obtained after washout of estrogen/progestin containing drugs;
    • or at least 6 weeks postsurgical bilateral oophorectomy.
  • For hysterectomized subjects:
    • serum FSH > 40 mIU/mL and E2 < 20 pg/mL (values obtained after washout of estrogen/progestin containing drug;
    • or at least 6 weeks post-surgical bilateral oophorectomy.
  • Good physical and mental health, in the judgement of the Investigator as based on medical history, physical and gynecological examination, and clinical assessments performed prior to Visit 1.
  • Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
  • Able and willing to complete trial daily diaries and questionnaires.

* Subjects must have a Breast Imaging-Reporting And Data System (BI-RADS) score of 1 or 2 to enroll in the study. An incomplete mammogram result, i.e., BI-RADS 0, is not acceptable. and requires further assessment (Amendment 5, 23 September, 2020). The site must obtain a copy of the official report for the subject's study file. A digitalized imaging should be obtained if mammography is done as part of this study.


Exclusion Criteria:

  • History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin if diagnosed more than 1 year prior to the Screening visit.
  • Any clinically significant findings found by the Investigator at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer (however, simple cysts confirmed by ultrasound are allowed).
  • Papanicolaou (PAP) test with atypical squamous cells undetermined significance (ASC-US) or higher (low-grade intraepithelial lesion [LSIL], atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion [HSIL] [ASC-H], HSIL dysplastic or malignant cells) in sub-totally hysterectomized and non-hysterectomized subjects.
    • Note: ASC-US is allowed if a reflex human papilloma virus (HPV) testing is performed and is negative for high risk oncogene HPV.
  • For non-hysterectomized subjects:
    • History or presence of uterine cancer, endometrial hyperplasia, disordered proliferative findings;
    • Presence of endometrial polyp;
    • Undiagnosed vaginal bleeding;
    • Endometrial ablation;
    • Enlarged uterus with myoma.
  • Systolic blood pressure (BP) higher than 130 mmHg, diastolic BP higher than 80 mmHg during screening.
  • History of venous or arterial thromboembolic disease (e.g., superficial or deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, angina pectoris, etc.), or first degree family history of venous thromboembolism (VTE).
  • History of known acquired of congenital coagulopathy or abnormal coagulation factors, including known thrombophilias.
  • Diabetes mellitus with poor glycemic control in the last 6 months assessed by laboratory values of fasting glucose outside the normal ranges and glycated hemoglobin above 7%.
  • Dyslipoproteinaemia (LDL > 190 mg/dL and triglycerides > 300 mg/dL).
  • Smoking:
    • Efficacy Study part: subjects smoking > 5 cigarettes per day or > 2 packs per week;
    • Safety Study part: subjects smoking > 15 cigarettes per day or > 6 packs per week.
  • Presence or history of gallbladder disease, unless cholecystectomy has been performed.
  • Systemic lupus erythematosus.
  • Any malabsorption disorders including gastric by-pass surgery.
  • History of acute liver disease in the preceding 12 months before the start of screening or presence of chronic liver disease [alanine transaminase (ALT) or aspartate transaminase (AST) >2 x upper limit of normal (ULN), bilirubin >1.5 ULN].
  • Chronic or current acute renal impairment (estimated glomerular filtration rate <60 ml/min).
  • Porphyria.
  • Diagnosis or treatment of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, etc.) in the judgement of the Investigator.
  • Use of estrogen/progestin containing drug(s) up to:
    • 1 week before screening start for vaginal non systemic hormonal products (rings, creams, gels).
    • 4 weeks before screening start for vaginal or transdermal estrogen or estrogen/progestin products.
    • 8 weeks before screening start for oral estrogen and/or progestin products and/or selective estrogen receptor modulator therapy.
    • 8 weeks before screening start for intrauterine progestin therapy.
    • 3 months before screening start for progestin implants or estrogen alone injectable drug therapy.
    • 6 months before screening start for estrogen pellet therapy or progestin injectable drug therapy.
    • Use of androgen/ dehydroepiandrosterone (DHEA) containing drugs:
      • 8 weeks before screening start for oral, topical, vaginal or transdermal androgen;
      • 6 months before screening start for implantable or injectable androgen therapy.
  • Use of phytoestrogens or black cohosh for treatment of VMS up to 2 weeks before the start of screening.
  • For the women participating in the Efficacy Study part: use of prescription or over-the-counter products used for the treatment of VMS; e.g., anti-depressants: paroxetine, escitalopram, methyldopa, opioid and clonidine up to 4 weeks before the start of screening, and venlafaxine and desvenlafaxine up to 3 months before the start of screening , and not willing to stop these during their participation in the trial.
  • Inadequately treated hyperthyroidism at screening.
  • History or presence of allergy/intolerance to the investigational product or drugs of this class or any component of it, or history of drug or other allergy that, in the opinion of the Investigator contraindicates subject participation.
  • For non-hysterectomized subjects: history or presence of allergy to peanuts.
  • History of alcohol or substance abuse (including marijuana, even if legally allowed) or dependence in the previous 12 months before the start of screening as determined by the Investigator, based on reported observations.
  • Sponsor or contract research organization (CRO) employees or employees under the direct supervision of the Investigator and/or involved directly in the trial.
  • Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies that would pose a risk to the subject in the opinion of the Investigator.
  • Participation in another investigational drug clinical trial within 1 month (30 days) or having received an investigational drug within the last 1 month (30 days) before the start of screening.
  • Is judged by the Investigator to be unsuitable for any reason.

 

Drug, Other, Drug therapy
Abnormal vasomotor function, Estetrol [USAN], Menopausal and postmenopausal disorders, Postmenopausal state, Reproductive system
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Mayo Clinic — Rochester, MN

Prevalence of Depression and Anxiety in Newly- diagnosed Breast Cancer Patients in a Community Hospital: A pilot study

A Study to Analyze the Prevalence of Depression and Anxiety in Newly-diagnosed Breast Cancer Patients in a Community Hospital

Scott Okuno
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122828-H01-ALCL
19-010348
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Inclusion Criteria:
 

  • Adult woman aged 18 or older.
  • Diagnosis of biopsy-proven invasive breast cancer at Mayo Clinic Health System, Austin and Albert Lea, MN.


Exclusion Criteria:
 

  • Concomitant 2nd malignancy.
  • Recurrent malignancy.
  • Pregnancy.
  • Age over 80 years.

 

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Mayo Clinic Health System — Albert Lea, MN

Prevalence of Depression and Anxiety in Newly- diagnosed Breast Cancer Patients in a Community Hospital: A pilot study

A Study to Analyze the Prevalence of Depression and Anxiety in Newly-diagnosed Breast Cancer Patients in a Community Hospital

Scott Okuno
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122828-H01-RST
19-010348
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Inclusion Criteria:
 

  • Adult woman aged 18 or older.
  • Diagnosis of biopsy-proven invasive breast cancer at Mayo Clinic Health System, Austin and Albert Lea, MN.


Exclusion Criteria:
 

  • Concomitant 2nd malignancy.
  • Recurrent malignancy.
  • Pregnancy.
  • Age over 80 years.

 

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Location Contacts
Mayo Clinic — Rochester, MN

Prevalence of Depression and Anxiety in Newly- diagnosed Breast Cancer Patients in a Community Hospital: A pilot study

A Study to Analyze the Prevalence of Depression and Anxiety in Newly-diagnosed Breast Cancer Patients in a Community Hospital

Scott Okuno
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122828-H01-AUAC
19-010348
Show full eligibility criteria
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Inclusion Criteria:
 

  • Adult woman aged 18 or older.
  • Diagnosis of biopsy-proven invasive breast cancer at Mayo Clinic Health System, Austin and Albert Lea, MN.


Exclusion Criteria:
 

  • Concomitant 2nd malignancy.
  • Recurrent malignancy.
  • Pregnancy.
  • Age over 80 years.

 

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Location Contacts
Mayo Clinic Health System — Austin, MN