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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.

3402 Study Matches

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Comparison of Qualitative and Quantitative Dual-Energy CT and/or Whole Body MRI Parameters for Longitudinal Monitoring Of Bone Involvement in Patients With Multiple Myeloma.

A Study to Compare Dual-Energy CT and Whole Body MRI for Monitoring of Bone Involvement in Multiple Myeloma Patients

Francis Baffour
All
30 years and over
This study is NOT accepting healthy volunteers
0000-121468-H01-RST
18-010632
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Inclusion Criteria:

  • Patients 30 years of age or older.
  • Provision of signed and dated informed consent form.
  • Diagnosis of multiple myeloma requiring therapy or relapsed multiple myeloma requiring change in therapy.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Non-pediatric patient.


Exclusion Criteria:

  • Pediatric patient.
  • Have known metallic implants that preclude MR scanning.
  • Pregnant (a urine pregnancy test will be given at no cost to the patient).
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Mayo Clinic — Rochester, MN

Detection of Actionable or Predictive Tumor DNA Mutations in Peripheral Blood (Liquid Biopsy) from Patients with Cholangiocarcinoma (CCA)

A Study to Detect Actionable or Predictive Tumor DNA Mutations in Peripheral Blood (Liquid Biopsy) from Patients with Cholangiocarcinoma (CCA)

Lewis Roberts
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121470-H01-RST
18-010647
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Inclusion Criteria:
 

  • Adult, age ≥ 18 years old.
  • Patients with active disease of intrahepatic, perihilar, distal CCA with histologic confirmation.
  • Patients whose clinical provider orders cancer tissue mutation profiling test for clinical care.


Exclusion Criteria:
 

  • Females who are pregnant or attempting to become pregnant.
  • Patient with significant anemia (Hemoglobin <7g/dL).
Cancer, Cholangiocarcinoma
Cholangiocarcinoma of biliary tract, Digestive system, Medical Oncology, Primary cholangiocarcinoma of intrahepatic biliary tract, Primary malignant neoplasm of distal bile duct, Primary malignant neoplasm of perihilar bile duct
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Mayo Clinic — Rochester, MN

Request to Obtain Samples of Blood from Patients Suffering From Neuromuscular Disorders

A Study to Collect Blood Samples from Patients with Neuromuscular Disorders

Duygu Selcen
All
up to 99 years old
This study is NOT accepting healthy volunteers
0000-121472-H01-RST
18-010668
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Inclusion Criteria:

  • Phenotypic criteria pointing to a genetically determined neuromuscular disease.
  • Living and deceased subjects will be included.


Exclusion Criteria:

  • None.

 

 

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Mayo Clinic — Rochester, MN

Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation using the Philips MRI

Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation using the Philips MRI

Aiming Lu
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121474-H01-RST
18-010671
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Inclusion Criteria:

  • Male or female.
  • Age ≥ 18 years.
  • Healthy volunteers
    or patients already scheduled for a MR-guided procedure.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Pregnant women.
MRI guided ablation, Other
MRI
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Mayo Clinic — Rochester, MN

Prevalence, Incidence and Predictors for Development of the Impulse Control Disorders in Patients with Prolactinomas Treated with Dopamine Agonist Therapy: a prospective observational study.

A Study Evaluating the Prevalence, Incidence and Predictors for Development of the Impulse Control Disorders in Patients with Prolactinomas Treated with Dopamine Agonist Therapy

Irina Bancos
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121478-H01-RST
18-010693
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Inclusion Criteria:

  • Age 18 years old and above.
  • Diagnosis of prolactinoma.
  • Ability to provide informed consent.


Exclusion Criteria:

  • None.

Prolactinoma
Dopamine, Endocrine system, Impulse control disorder, Prolactinoma, dopamine
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Mayo Clinic — Rochester, MN

Glycemic Variability Assessment in Complex Diabetes During Hospitalization

Glycemic Variability Assessment in Complex Diabetes During Hospitalization

Yogish Kudva
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121494-H01-RST
18-010796
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Inclusion Criteria:

  • Type 1 diabetes diagnosed clinically.
  • Willing to perform study procedures and provide data for at least 10 days.


Exclusion Criteria:

  • Pregnant.
Diabetes, Type 1 diabetes
Endocrine system, Patient requires hospitalization, Poor glycemic control, Type 1 diabetes mellitus
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Mayo Clinic — Rochester, MN

Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

A Study to Evaluate a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

Annalise Larson
All
10 years to 15 years old
This study is NOT accepting healthy volunteers
0000-121522-H01-RST
18-011112
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Inclusion Criteria:
 

  • Idiopathic Scoliosis (as diagnosed by the surgeon).
  • Patients above 10 years old at the time of recruitment.
  • Spina bifida occulta with no neurological signs and otherwise normal.
  • Curves ranging between 11º and 40º of Cobb angle measurement and
    •Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine. 
  • All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study.


Exclusion Criteria:

  • Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation.
  • Congenital scoliosis,
    •MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Syndromic scoliosis (associated with Marfan's or other genetic syndromes).
  • Neuromuscular scoliosis.
  • Developmental delay. 
  • Spinal asymmetry. 
  • Symptomatic spondylolisthesis. 
  • Leg length discrepancy longer than 1 cm. 
  • Unable or unwilling to firmly commit to returning for required follow-up visits.
Scoliosis
Adolescent idiopathic scoliosis, Musculoskeletal system, Spina bifida occulta
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Mayo Clinic — Rochester, MN

Can Ultrasound Detect Medial Meniscal Extrusion More Frequently Than MRI?

A Study to Evaluate Whether Ultrasound Can Detect Medial Meniscal Extrusion More Frequently Than MRI?

Adam Johnson
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
0000-121530-H01-MPMC
18-011204
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Inclusion Criteria:

  • Adult male or female between 18 and 65 years of age.
  • Adult male or female who is scheduled to receive a knee MRI at our facility. 


Exclusion Criteria:

  • Prior history of knee surgery.
  • Inability to WB
  • MRI incompatibility (e.g., presence of ferromagnetic implants, claustrophobia, etc.). 
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Mayo Clinic Square — Minneapolis, MN

Rochester Older Adult Registry (ROAR) (ROAR)

A Study to Establish a Rochester Older Adult Registry (ROAR)

Robert Pignolo
All
65 years and over
This study is NOT accepting healthy volunteers
0000-121532-H01-RST
18-011235
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Inclusion Criteria:

  • Patients had to be seen by a health care provider at least once at the Family Medicine and Primary Care Internal Medicine clinics of Mayo Clinic in Rochester, MN or the Mayo Clinic Health System during the study time. 
  • Patients had to be empaneled to a primary care provider.
  • Ability to give informed consent.
  • Ability to read and speak the English language.
  • Age 65 or older.


Exclusion Criteria:
 

  • Patients that had not to be seen by a health care provider during the study time.
  • Any participant who refused medical record review.
  • Incarcerated individuals.
  • Hospice enrollment.
  • Memory Care residents.
  • Major Neurocognitive disorder (severe and moderate dementia).

 

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Mayo Clinic — Rochester, MN

Proinsulin and Glucagon Secretion in Postpartum Women with and without Gestational Diabetes

A Study to Evaluate Proinsulin and Glucagon Secretion in Postpartum Women with and without Gestational Diabetes

Adrian Vella
Female
20 years to 40 years old
This study is NOT accepting healthy volunteers
0000-121537-H01-RST
18-011294
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Inclusion Criteria:

  • Fifteen women with GDM and 15 women without GDM will be recruited through the Mayo Clinic Obstetric Practice in Rochester, Minnesota in the third trimester of pregnancy.
  • The screening visit will be scheduled from 2-12 weeks postpartum.
  • Gestational diabetes will be diagnosed based on Carpenter and Coustan criteria when at least two of the following four plasma glucose concentrations [measured fasting and 1h, 2h and 3h during 100g oral glucose tolerance testing)(OGTT)] are met or exceeded:
    • fasting 95mg/dL (5.3mmol/L);
    • 1h 180mg/dL (10.0mmol/L);
    • 2h 155mg/dL (8.6mmol/L); and
    • 3h 140mg/dL (7.8mmol/L).
  • Women will be characterized as having normal glucose tolerance if they do not meet or exceed two or more of the aforementioned values on OGTT. These women will have previously failed a 50g glucose challenge [1 hr glucose >= 140mg/dL (7.8mmol/L).
  • We will also characterize women as having normal glucose metabolism if they passed a 50g glucose challenge in pregnancy [1 hr glucose <140mg/dL (7.8mmol/L)] and did not proceed to further glucose testing during the pregnancy.


Exclusion Criteria:

  • Women < 20 years of age or > 40 years of age will not be studied to minimize the potential confounding effects of extremes of age on glucose absorption and metabolism.
  • Known active systemic illness.
  • Women in which the index pregnancy was a multiple pregnancy.
  • Women with an HbA1c of ≥ 5.7% (39mmol/mol) in early pregnancy or a history of diabetes.
  • Prior therapy with an anti-diabetic medication, or a medication that could affect glucose metabolism.
  • History of abdominal surgery (other than appendectomy, cholecystectomy or tubal ligation).
Gestational diabetes
Endocrine system, Gestational diabetes mellitus, Postpartum gestational diabetes mellitus
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Mayo Clinic — Rochester, MN

Ultrasound Evaluation of Liver Steatosis

A Study to Evaluate Ultrasound of Liver Steatosis

Shigao Chen
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121540-H01-RST
18-011308
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Inclusion Criteria:

  • Patients with clinically indicated MRI PDFF for liver imaging.
  • Age greater than 18 years old.

Exclusion Criteria:

  • Age under 18 years old.
  • Vulnerable subjects such as prisoners and adults lacking capacity to consent.
  • Patient with liver iron overload which may confound PDFF measurements.

 

MRI, Steatosis of liver, Ultrasound
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Mayo Clinic — Rochester, MN

Prediction of Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers

A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers

Patricio Gargollo
All
up to 17 years old
This study is NOT accepting healthy volunteers
0000-121958-H01-RST
19-002795
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Inclusion Criteria:

  • Any patient undergoing surgery or biopsy for malignancy in the kidney, bladder, prostate.
  • Any patient undergoing resection or biopsy of tumor recurrence after surgery for malignancy in the kidney, bladder, prostate.
  • Any patient undergoing resection or biopsy of tumor metastatic site after surgery for malignancy in the kidney, bladder, prostate.


Exclusion Criteria:
 

  • Inability to provide consent.
  • Specimen and data related to this pilot study will be retained for future use in case we wish to perform further related studies and include these pilot patients in ensuing analyses. In that case, re-consent of patients will be required when they turn 18.   
Bladder cancer, Cancer, Kidney cancer, Prostate cancer, Recurrent cancer
Biological therapy for cancer, Cancer treatment, Kidney biopsy, Medical Oncology, Primary malignant neoplasm of bladder, Primary malignant neoplasm of kidney, Primary malignant neoplasm of prostate, Prostate biopsy, Recurrent malignant neoplastic disease, Reproductive system, Resistance to antineoplastic drug, Secondary malignant neoplasm of bladder, Secondary malignant neoplasm of kidney, Secondary malignant neoplasm of prostate, Urinary system, Virotherapy
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Mayo Clinic — Rochester, MN

Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders

A Study to Evaluate Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders

Orhun Kantarci
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121961-H01-RST
19-002807
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Inclusion Criteria:

  • Patients from both genders and all ethnic backgrounds will be allowed with no reservation.


Exclusion Criteria:
 

  • Patients who do not consent to the study will be excluded despite being sequential.
Demyelinating disease, Multiple sclerosis
Multiple sclerosis, Nervous system
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Mayo Clinic — Rochester, MN

Prospective Comparison of 3- and 4-Part Proximal Humerus Fractures Undergoing Elected Nonoperative vs. Operative Management

A Study to Compare 3- and 4-Part Proximal Humerus Fractures Undergoing Elected Nonoperative vs. Operative Management

Jonathan Barlow
All
65 years to 90 years old
This study is NOT accepting healthy volunteers
0000-121962-H01-RST
19-002821
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Inclusion Criteria:

  • Displaced 3- and 4-part proximal humerus fractures.
  • Age ≥ 65 years old and < 90 years old.


Exclusion Criteria:

  • < 65 years old or ≥ 90 years old.
  • Medical comorbidities precluding surgical treatment or anesthesia.
  • Dementia or inability to provide adequate follow up.
  • Pathologic fractures.
  • Open fractures.
  • Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

 

Broken arm, Fracture
Arthroplasty, Closed fracture proximal humerus, four part, Closed fracture proximal humerus, three part, Fracture pain, Joint replacement, Musculoskeletal system, Open fracture proximal humerus, four part, Open fracture proximal humerus, three part, Reverse shoulder replacement, Shoulder replacement, Joint replacement surgery, Reverse shoulder replacement surgery, Shoulder replacement surgery, Shoulder surgery
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Mayo Clinic — Rochester, MN

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation

A Study to Evaluate the Use of The Sentinel Device During Atrial Fibrillation Ablation

Malini Madhavan
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121965-P01-RST
19-002836
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Inclusion Criteria:


- Men / women over the age of 18 years undergoing radiofrequency or cryo-balloon
ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of
patients with atrial fibrillation. This includes patients with symptomatic paroxysmal,
persistent or long-standing persistent AF not responsive to or intolerant of a Class I
or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF
prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision
to perform catheter ablation for AF will be made by the treating provider and the
patient in accordance with the guidelines noted above. (January et al. J Am Coll
Cardiol vol. 64, No. 21, 2014, page e1)

- Able to provide informed consent.

- Patients should have acceptable aortic arch anatomy and vessel diameters without
significant stenosis as assessed using pre-procedure CT angiogram.


Exclusion Criteria:


- Anatomy unsuitable for use of Sentinel device:

- Right extremity vasculature not suitable due to compromised arterial blood flow.

- Brachiocephalic, left carotid or aortic arch not suitable due to excessive
tortuosity, significant ectasia, stenosis (>70%), dissection or aneurysm.

- Cerebrovascular accident or transient ischemic attack within six months

- Carotid disease requiring treatment within six weeks

- Unable or unwilling to provide informed consent.

- Pregnant women

- Known history of dementia.

- Known hypersensitivity to nickel-titanium.

- Presence of MRI non-compatible implanted devices including cardiac implantable
electronic devices.

- The presence of left atrial thrombus. All patients routinely undergo transesophageal
echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the
beginning of the ablation procedure to rule out the presence of left atrial thrombus.

- Patients with a reversible cause for AF such as hyperthyroidism.

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

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

A Randomized, Controlled Trial of Simulated Sylvian Fissure Dissection Under Subarachnoid Hemorrhage Conditions Using a Rodent Microvascular Anastomosis Model

A Study of Simulated Sylvian Fissure Dissection Under Subarachnoid Hemorrhage Conditions Using a Rodent Microvascular Anastomosis Model

Michael Link
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121973-H01-RST
19-002906
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Inclusion Criteria:

  • Neurologic Surgery, ENT, plastic surgery, orthopedic surgery, urology resident, fellow and staff surgeons.


Exclusion Criteria:
 

  • Unable to give informed consent.

 

Device, Procedure/Surgery, Microvascular anastomosis
Aneurysm, Brain aneurysm, Brain hemorrhage, Hemorrhage, Intracranial hemorrhage, Subarachnoid hemorrhage
Nervous system, Subarachnoid hemorrhage due to ruptured aneurysm
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Mayo Clinic — Rochester, MN

Advanced Multiparametric MR Elastography (MRE) in Diagnosing and Monitoring Disease Progression in Patients with Cirrhosis or Hepatocellular Carcinoma (HCC)

A Study to Assess Multiparametric MR Elastography (MRE) in Diagnosing and Monitoring Cirrhosis or Hepatocellular Carcinoma (HCC) Patients

Douglas Simonetto
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121977-H01-RST
19-002921
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Inclusion Criteria:

  • Age ≥ 18 years old (HCC is rare in US children).
  • Diagnosis of HCC with cross-sectional imaging or histology.
  • 3D MRE of the liver was performed within 1 month of diagnosis.


Exclusion Criteria:
 

  • History of secondary hepatic malignancy.
  • Any medical condition that, in the opinion of the Principal Investigators, would serve as exclusion criteria.
Cancer, Cirrhosis, Hepatocellular carcinoma, Liver cancer
Cancer treatment, Cirrhosis of liver, Digestive system, Liver cell carcinoma, MRI, Magnetic resonance elastography, Medical Oncology
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Mayo Clinic — Rochester, MN

Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring (MVSC)

A Study to Quantify Microvasculature Imaging for Breast Cancer Detection and Monitoring

Azra Alizad
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
0000-121989-H01-RST
19-003028
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Inclusion Criteria
•Aim 1:

  • Patient volunteers, ages ≥ 18 years.
  • Having suspicious breast masses scheduled for breast biopsy.
  • At least two weeks or more after breast biopsy.

Inclusion Criteria
•Aim 2:

  • Patient volunteers, ages ≥ 18 years.
  • Suspicious breast masses scheduled for breast biopsy.
  • At least two weeks or more after breast biopsy.

Exclusion Criteria
•Aims 1 and 2: 

  • Patients with breast implants, mastectomy or any condition that does not allow proper use of U.S.

     

     

     

     

Breast cancer, Breast lumps, Cancer, Suspicious breast lumps
Breast biopsy, Breast lump, Cancer treatment, Chemotherapy, Chemotherapy for breast cancer, Lesion of breast, Medical Oncology, Reproductive system, Breast ultrasound, Supplemental breast cancer screening
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Mayo Clinic — Rochester, MN

GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women (GENRE 2) (GENRE2)

GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance

Sandhya Pruthi
Female
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-121995-H01-RST
19-003085
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Inclusion Criteria:

  • Women > 35 years old and < 75 years old with at least one of the following:
    • A NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force; or
    • IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥ 5%;
    • History of atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT ≥ 3% or IBIS ≥ 5%; OR
  • Women ≥ 18 years old or ≤ 75 years old with a:
    • BRCA 1 or 2  mutation;
    • CHEK 2;
    • PALB 2;
    • ATM; or
    • Other hereditary breast mutation carrier per investigator; AND
  • Able to participate in all aspects of the study.
  • Understand and sign the study informed consent. 


Exclusion Criteria:

      1.  
  • Women whose BCRAT falls below the threshold (< 3% 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is < 5% for the 10 year risk.
  • Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole.
  • Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole for ≥ 6 months.
  • Unable to give informed consent.
  • Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers.
  • History of ovarian cancer within the last 2 years.
  • Recurrence of ovarian cancer at any timepoint.
  • Prior bilateral  prophylactic mastectomy.
  • Women who are currently pregnant.

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

Breast cancer, Cancer
At risk of breast cancer, Breast cancer risk assessment, Cancer treatment, Exemestane, Genetic testing, Medical Oncology, Raloxifene, Tamoxifen [INN:BAN], exemestane, raloxifene, tamoxifen, Hormone therapy for breast cancer
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A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease (FALCON)

A Study to Evaluate Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Vicente Torres
All
12 years to 70 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-121996-P01-RST
19-003093
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Inclusion Criteria:


- Male and female patients 12 ≤ age ≤ 70 upon study consent;

- Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by
sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at
least 10 cysts per kidney by any radiologic method and exclusion of other cystic
kidney diseases if without family history;

- Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73
m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):

1) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70
years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0
mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor
discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to
determine eligibility must have a percent difference ≤ 25%;

- Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit;

- Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A
visit after a period of rest.


Exclusion Criteria:


- History of administration of polycystic kidney disease-modifying agents (somatostatin
analogues) within 3 months prior to the Screen A visit;

- B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;

- Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;

- Serum albumin < 3 g/dL at Screen A visit;

- History of intracranial aneurysms;

- Kidney or any other solid organ transplant recipient or a planned transplant during
the study;

- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or
during Screening;

- History of clinically significant left-sided heart disease and/or clinically
significant cardiac disease;

- Systolic BP < 90 mm Hg at Screen A visit after a period of rest;

- BMI < 18.5 kg/m2 at the Screen A visit;

- History of malignancy within 5 years prior to Screen A visit, with the exception of
localized skin or cervical carcinomas;

- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks
prior to randomization or anticipated need for immunosuppression during the study;

- Untreated or uncontrolled active bacterial, fungal, or viral infection;

- Participation in other interventional clinical studies within 30 days prior to Day 1;

- Unwilling to practice acceptable methods of birth control (both males who have
partners of child-bearing potential and females of childbearing potential) during
Screening, while taking study drug, and for at least 30 days after the last dose of
study drug is ingested;

- Women who are pregnant or breastfeeding;

- Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan
must have discontinued drug for at least 3 months prior to Screen A visit

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

Eligibility last updated 12/20/22. Questions regarding updates should be directed to the study team contact.

Drug therapy, Drug
Polycystic kidney disease
Autosomal dominant polycystic kidney disease, Bardoxolone, Urinary system
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Mayo Clinic — Rochester, MN

Performance Metrics and Their Relationship with Competition Results and Injury Development in Nordic Combined and Ski Jumping Athletes

A Study of Performance Metrics and Their Relationship with Competition Results and Injury Development in Nordic Combined and Ski Jumping Athletes

Jonathan Finnoff
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121557-H01-RST
18-011406
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Inclusion Criteria:

  • All national team Nordic Combined and Ski Jumping athletes age 18 and over will be eligible to participate in the study.


Exclusion Criteria:
 

  • Inability to complete the online questionnaires.

 

Sports injury
Injury while engaged in sports activity, Musculoskeletal system, Sport specific rehabilitation
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Mayo Clinic — Rochester, MN

Measuring Markers of Immune Tolerance to Predict Women at Risk of Miscarriage or Failed Embryo Transfer

A Study to Measure Markers of Immune Tolerance to Predict Women at Risk of Miscarriage or Failed Embryo Transfer

Chandra Shenoy
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-121560-H01-RST
18-011413
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Inclusion Criteria
•Infertility Cohort

  • Adult females undergoing a euploid frozen embryo transfer.
  • Women age 18 years of age or older.
  • Must be planning to have all blood work done at Mayo Clinic Rochester so we can receive the study samples.
  • Must be planning to deliver within the Mayo Clinic Health System so that we can review pregnancy outcomes.

Exclusion Criteria
•Infertility Cohort: 

  • Non English speaking.
  • Less than 18 years of age.
  • Planning follow-up outside Mayo Clinic Rochester/MCHS.
  • Pregnancies with multiple fetuses.

Inclusion Criteria
•Spontaneous Conception Cohort

  • Adult women presenting with positive pregnancy test to the Obstetrics Department.
  • Women age 18 years of age or older.
  • Confirmed intrauterine pregnancy (defined as gestational sac with yolk sac +/- fetal pole).
  • Patients need to be planning to deliver within the Mayo Clinic Health System so that we can review pregnancy outcomes.

Exclusion Criteria
•Spontaneous Conception Cohort: 

  • Non English speaking.
  • Less than 18 years of age.
  • Planning follow-up outside Mayo Clinic Rochester/MCHS.
  • Patients desiring termination of pregnancy.
  • Known miscarriage at the time of recruitment.
  • Pregnancies with multiples.

 

Miscarriage
Fetal demise from miscarriage, Finding related to risk factor in pregnancy, High risk pregnancy, IVF - in-vitro fertilization pregnancy, In vitro fertilization, Livebirth, Reproductive system
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A Video Reflexive Ethnography Study of Patient Experience and Inter-team Collaboration Post-Transplant Surgery

A Study of Patient Experience and Inter-Team Collaboration Post Transplant Surgery

Anja Roden
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121563-H01-RST
18-011439
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Inclusion Criteria:

  • Clinical staff within the Division of Anatomy Pathology- staff pathologists, pathology assistants, transplant surgeons, transplant clinicians, laboratory assistants, reporting specialist, RN coordinators, and other clinical staff.
  • Patients who have undergone transplant surgery and have been offered an “interactive conference”, and their family members.


Exclusion Criteria:
 

  • Clinical staff not involved in transplant surgery.
  • Non-transplant patients and their family members.
Transplant follow-up, Transplant present
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Assessment of frailty and clonal hematopoiesis in adults with hematological diagnosis

A Study to Evaluate the Correlation Between Frailty, Adverse Outcome and Clonal Hematopoiesis

Mrinal Patnaik
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121567-H01-RST
18-011471
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Inclusion Criteria:

  • All patients ≥ 18 years old.
  • With a diagnosis of hematology malignancy.
  • Willing and able to provide written informed consent.


Exclusion Criteria:

  • < 18 years old.

 

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A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain

A Study to Evaluate the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain

Matthew Pingree
All
22 years to 70 years old
Phase 1, Feasibility
This study is NOT accepting healthy volunteers
0000-121568-P01-RST
18-011475
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Inclusion Criteria:


- Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet
arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or
L6-S1).

- Positive response, defined according to current clinical standards for the diagnosis
of facet-mediated low back pain as greater than or equal to 75% pain improvement (as
reported by patient) to diagnostic medial branch nerve blocks, one block with
lidocaine and the other with bupivacaine.

- Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior
to the first medial branch nerve block.


Exclusion Criteria:


- Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency
ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.

- Current opioid use of greater than 50mg oral morphine milligram equivalents per day.

- No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6
months.

- BMI > 34.99 (WHO class I obesity).

- Active systemic or local infection as evidenced by fever >100.4 degrees Fahrenheit, or
any other clinical signs or symptoms of infection within 24 hours of the procedure.

- On anticoagulation drug and has been on hold for less than 7 days prior to the
investigational procedure.

- Imaging evidence of high likelihood of failure for intra-articular injection in the
opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.

- History of chronic thrombocytopenia (or pre-operative platelet count less than 195,000
per ?l).

- Undergoing chemotherapy at time of injection.

- Pregnant or breastfeeding.

- Use of illicit drugs within 30 days prior to study entry.

- NSAID use during the pre-procedural period (one week before Treatment Day 0).

- Preoperative hematocrit less than 36%.

- History of hemodynamic instability or inability to maintain stable oncotic pressure.

- History of prolonged clotting times.

- Prior history of lumbar procedure.

- Redness, swelling, rash or other concerning lesions at the injection site just prior
to the procedure.

- Prior history of allergy to lidocaine or other local anesthetic agent.

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

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Combination Product
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A Pilot Study to Evaluate the Molecular and Biological Phenotype of Peripheral Immune Cells in Solid Tumor Patients

A Pilot Study to Evaluate the Molecular and Biological Phenotype of Peripheral Immune Cells in Solid Tumor Patients

Wen Wee Ma
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121574-H01-RST
18-011517
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Inclusion Criteria:

  • Patient must have cytologically or histologically confirmed solid tumor;
  • Age 18 years and above;
  • Willingness to undergo venipuncture; and
  • Woman known to be pregnant is excluded.


Exclusion Criteria:

  • None.
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Analgesic Use and Duration for Pediatric Long Bone Fractures

A Study to Evaluate Analgesic Use and Duration for Pediatric Long Bone Fractures

Jana Anderson
All
up to 18 years old
This study is NOT accepting healthy volunteers
0000-121576-H01-RST
18-011554
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Inclusion Criteria:

  • Age less than 18 years.
  • Present at St. Marys Emergency Department, Mayo Clinic, Rochester, MN.
  • The fracture is acute, < 24 hours from time of injury.
  • The fracture is of a long bone (radius, ulna, humerus, tibia, fibula or femur).


Exclusion Criteria:

  • Any metabolic, nutritonal or genetic bone disease.
  • The patient was taking an opioid within the last 7 days prior to the fracture for any reason.
  • Any child who’s fracture is suspected to be due to abuse.
  • Any child with a previous or current pain syndrome or “chronic” pain.
  • Any child who has static encephalopathy or an altered perception of pain.
  • The patients is in foster care, county custody, police custody or currently incarcerated.
  • Pregnancy.

 

Broken arm, Broken leg, Fracture, Acute pain
Acute pain due to injury, Fracture of femur, Fracture of fibula, Fracture of humerus, Fracture of radius, Fracture of tibia, Fracture of ulna, Musculoskeletal system
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Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients following Coronary Stent Implantation (EV-CSI) (EV-AMI)

A Study to Evaluate the Safety of Intracoronary Infusion of Extracellular Vesicles in Patients with Acute Myocardial Infarction

Guy Reeder
All
21 years to 85 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-121586-P01-RST
18-011636
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Inclusion Criteria:


- Ages 21-85

- Males and females

- Acute myocardial infarction (ST elevation at the J point in at least 2 contiguous
leads of

≥2 mm (0.2 mV) in men or ≥1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥1 mm
(0.1 mV) in other contiguous chest leads or the limb leads)

- Successful stent implantation within 4 and 12 hours from onset of AMI symptoms

- Angiographic evidence of TIMI 0 or TIMI 1 flow through culprit lesion prior to stent
placement

- Angiographic evidence of residual stenosis visually <30% after stent placement

- Willing and able to provide signed informed consent

- Lives within 90 mile radius of study site


Exclusion Criteria:


- Prior cardiovascular history of systolic or diastolic dysfunction or acute myocardial
infarction

- Prior solid organ transplantation at any time

- Pregnant or lactating at screening

- Known presence of chronic systemic inflammatory disorder that requires ongoing therapy
with immunosuppressive agents

- Known immune system compromise including but not limited to human immunodeficiency
virus (HIV), hepatitis A, hepatitis B (HBV) or hepatitis C (HCV) infection

- Known history of malignancy of any type except non-melanoma skin cancer

- Known serum creatinine >2 mg/dL or GFR ≤30 mL/min within the last twelve months

- Known AST, ALT, and/or bilirubin (total) elevated twice the upper limit of normal for
age & gender within the last twelve months

- Known Hemoglobin lower than 8.0 g/dL within the last twelve months

- Known current illicit drug use at screening

- Other major surgical procedure or major trauma within the previous 14 days prior to
enrollment

- Female of child bearing potential who is unwilling to agree to use acceptable
contraception methods for 3 months after receiving the investigational drug

- ICD implant in place

- Adult lacking decision-making capacity

- Prisoner

- Non-English speaking

- English-speaking but illiterate

- Legally blind

- Known allergy to heparin or heparin-induced thrombocytopenia

- Known history of positive SARS-CoV2 PCR nasal swab test

- DNR/DNI status prior to PCI procedure or planned DNR/DNI status after PCI

Eligibility last updated 6/21/22. Questions regarding updates should be directed to the study team contact.

Drug
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An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria (PHYOX 3)

An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

John Lieske
All
0 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121593-P01-RST
18-011726
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Inclusion Criteria:

  • Participant must be at least 6 years of age, at the time of signing the informed consent/assent.
  • Documented diagnosis of PH, confirmed by genotyping (historically available genotype information is acceptable for study eligibility).
  • Participant successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR-PHXC, or is the sibling of a participant who either successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR-PHXC or completed 24 weeks of participation in Study DCR-PHXC-204:
    • For participants rolling over from a multidose study of DCR-PHXC, enrollment should occur within a window of 25 to 75 days from the last dose of study intervention. In order to minimize any gap in administration of DCR-PHXC, every effort should be made to enroll participants as soon as all assessments from the previous study have been completed. It should be noted if the participant was required to repeat the end-of-study (EOS) 24-hour Uox collection for violation of completeness criteria;
    • Siblings must:
    • be younger than 18 years of age;
    • meet all other eligibility criteria (including genotyping) iii. have two 24-hour Uox values ≥ 0.7 mmol (adjusted per 1.73 m^2 BSA) at Screening OR for siblings aged 0 to 5 years old, average spot Uox-to-creatinine ratio at Screening above 2 times the 95th percentile for age based on Matos et al, 1999:
    • 0.44 mol/mol in participants < 6 months;
    • 0.34 mol/mol in participants from 6 months to < 12 months;
    • 0.26 mol/mol in participants 12 months to < 2 years;
    • 0.20 mol/mol in participants from 2 to < 3 years; and
    • 016 mol/mol in participants from 3 to 5 years.
  • Participants who perform 24-hour collections must have less than 20% variation between the two 24-hour urinary creatinine excretion values obtained in the screening period. Individuals who do not achieve < 20% variation between the 2 screening values may undergo a second round of urine collection. An extra 7 calendar days may be added to the screening window for participants to complete a second round of urine collection. Should potential participants again fail to achieve the within-20% variation, they will be excluded from participation.
  • Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m^2 BSA, calculated using the CKD-EPI equation in participants aged ≥ 18 years (Levey & Stevens, 2010), or the 2012 multivariate equation by Schwartz in participants aged 6 to 17 years (Schwartz et al., 2012). In Japan, the equation by Uemura et al. will be used for participants aged 6 to 17 years and the equation by Matsuo et al. will be used in participants aged ≥ 18 years (Uemura et al., 2014; Matsuo et al., 2009).
    • Note: For participants rolling over from a 6-month multidose study of DCR-PHXC, the eGFR value from either the Day 150 or Day 180 (EOS) visit may be used for screening.
  • Body weight ≥ 10.25 kg for participants rolling over from a previous study of DCR-PHXC OR body weight ≥ 12.75 kg for pediatric siblings.
  • A male participant with a female partner of childbearing potential must agree to use contraception, during the treatment period and for at least 12 weeks after the last dose of study intervention and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) during the treatment period and for at least 12 weeks after the last dose of study intervention.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Participant (and/or participant’s parent or legal guardian if participant is a minor [defined as patient < 18 years of age, or younger than the age of majority, according to local regulations]) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol:
    • Adolescents (12 to < 18 years of age, or older than 12 years but younger than the age of majority, according to local regulations) must be able to provide written assent for participation;
    • For children younger than 12 years of age, assent will be based on local regulations.


Exclusion Criteria:

  • Prior renal or hepatic transplantation; or planned transplantation within the study period;
  • Currently receiving dialysis.
  • Documented evidence of clinical manifestations of systemic oxalosis (including preexisting retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations).
  • Use of an RNAi drug (other than DCR-PHXC) within the last 6 months 5. History of one or more of the following reactions to an oligonucleotide-based therapy:
    • severe thrombocytopenia (platelet count ≤ 100,000/µL);
    • hepatotoxicity, defined as (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 × the upper limit of normal [ULN]) and (total bilirubin > 2 × ULN or International Normalized Ratio [INR] > 1.5);
    • severe flu-like symptoms leading to discontinuation of therapy;
    • localized skin reaction from the injection (graded severe) leading to discontinuation of therapy;
    • coagulopathy/clinically significant prolongation of clotting time.
  • Participants receiving pyridoxine (vitamin B6) must have been at a stable dose for at least 4 weeks prior to Day 1 and must be willing to remain on the same stable dose throughout the study.
  • Participation in any clinical study in which they received an investigational medicinal product (IMP) other than DCR-PHXC within 4 months before Screening:
    • For IMPs (other than DCR-PHXC) with the potential to reduce urine and/or plasma oxalate concentrations, these concentrations must have returned to historical baseline levels prior to Screening.
  • Plasma oxalate > 30 µmol/L.
    • Note: For participants > 18 years of age rolling over from a 6-month multidose study of DCR-PHXC, the plasma oxalate value from either the Day 150 or Day 180 (EOS) visit may be used for screening. If the previous study is blinded at the time of entry in DCR-PHXC-301, plasma oxalate values will be reviewed by the unblinded Medical Monitor. For participants ≤ 18 years of age rolling over from a 6-month multidose study of DCR-PHXC, the plasma oxalate value from Screening in the previous study will be used.
  • Known hypersensitivity to DCR-PHXC or any of its ingredients.
  • Inability or unwillingness to comply with the specified study procedures, including collection of 24-hour urine samples, and the lifestyle considerations.

Eligibility last updated 5/4/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug
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Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography

A Study to Assess Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography

Arjun Sebastian
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121596-H01-RST
18-011744
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Inclusion Criteria:
 

  •  ≥ 18 years old.
  • Primary diagnosis of spinal stenosis.
  • Surgical indication for 1 or 2 level posterior spinal decompression or fusion.


Exclusion Criteria:

  • Previous posterior spinal surgery.
  • Systemic corticosteroid use.
  • Long-term anticoagulation treatment.
  • Diagnosis of diabetes mellitus.
  • Diagnosis of peripheral arterial disease.
  • Current smoker.
  • Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis.
Spinal stenosis, Wound
Integumentary system, Minimally invasive lumbar decompression, Musculoskeletal system, Spinal fusion, Spinal stenosis, Spine decompression, Spine procedures, Wound care, Spine procedure
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