• Medical students and interns of the department of general surgery with experience of having placed <5 central venous catheters.

• Participants who do not consent to participate in the study.

• TIA with ABCD2 ≥ 4 or ischemic stroke, within the prior 14 days.

• Pre-event inability to perform all of own basic ADLs.
• Unable to obtain informed consent from subject or legally authorized representative.
• Incarcerated.
• Known pregnancy.
• Current mechanical ventilation (can enroll later if this resolves) or tracheostomy.
• Current use of positive airway pressure, or use within one month prior to stroke.
• Anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible.
• Severe bullous lung disease.
• History of prior spontaneous pneumothorax or current pneumothorax.
• Hypotension requiring current treatment with pressors (can enroll later if this resolves).
• Other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP.
• <assive epistaxis or previous history of massive epistaxis.
• Cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus.
• Recent hemicraniectomy or suboccipital craniectomy (i.e., those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure.
• Current receipt of oxygen supplementation > 4 liters per minute.

• Male and female volunteers > 18 years old.
• Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.

• Patients with gangrene.
• Patients with lower leg amputation.
• Having ulcer and any health condition that does not allow proper use of ultrasound scanning.
• People considered in “vulnerable” populations.

• All participants will be 50 years of age or older and younger than 85 years of age. 
• All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
• Other risk factors considered would include:
  • Caucasian race;
  • History of ever smoking (current or prior history of smoking);
  • BMI greater than equal to 30;
  •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
  •  Male sex.

• History of Barrett's esophagus or esophageal adenocarcinoma.
• Prior endoscopy in the last 10 years.
• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients with history of known varices or cirrhosis.
• Patients with history of esophageal or gastric resection.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
• Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

• All participants will be 50 years of age or older and younger than 85 years of age. 
• All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
• Other risk factors considered would include:
  • Caucasian race;
  • History of ever smoking (current or prior history of smoking);
  • BMI greater than equal to 30;
  •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
  •  Male sex.

• History of Barrett's esophagus or esophageal adenocarcinoma.
• Prior endoscopy in the last 10 years.
• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients with history of known varices or cirrhosis.
• Patients with history of esophageal or gastric resection.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
• Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

• All participants will be 50 years of age or older and younger than 85 years of age. 
• All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
• Other risk factors considered would include:
  • Caucasian race;
  • History of ever smoking (current or prior history of smoking);
  • BMI greater than equal to 30;
  •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
  •  Male sex.

• History of Barrett's esophagus or esophageal adenocarcinoma.
• Prior endoscopy in the last 10 years.
• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients with history of known varices or cirrhosis.
• Patients with history of esophageal or gastric resection.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
• Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

• Midlife women, ages 45-60 years old.
• Non-smokers.
• Non-obese.
• Have at least one ovary.
• Free from cardiovascular disease.
• Not taking medications influencing cardiovascular function.

• None.

• Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition.
• Subject scheduled to undergo a TIPS procedure.

• Minors under the age of 18 at the time of enrollment.
• Prisoners.
• Pregnant women.
• Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care.

• Histologically confirmed pancreatic adenocarcinoma with vascular involvement, either borderline/potentially resectable or locally advanced.
• Borderline resectable is defined by the NCCN as tumors (based on cross sectional imaging) with venous involvement of the SMV/portal vein demonstrated tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall. Tumors involving retroperitoneal structures that can be surgically removed (i.e., kidney), will also be included.
• Locally advanced unresectable disease is defined by the NCCN as: Tumors of the head that have greater than 180 degrees of SMA encasement or any celiac abutment, unreconstructable SMV or portal occlusion, or aortic invasion or encasement. Tumors of the body with SMA or celiac encasement of greater than 180 degrees, unreconstructable SMV or portal occlusion, or aortic invasion. Tumors of the tail with SMA or celiac encasement of greater than 180 degrees. Irrespective of location, all tumors with evidence of nodal metastasis outside of the resection field are deemed unresectable.
• Age ≥ 18 years old.
• ECOG Performance Status 0-1.
• Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
• Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy or 36 Gy in 15 fractions).
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.
• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential; i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
• Ability to understand and the willingness to sign a written informed consent document.

• Evidence of disease progression or distant metastases.
• Pregnant or lactating women.
• Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
• Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• An active infection requiring systemic therapy.
• Other serious medical conditions that the investigator feels might compromise study participation.

• > 18 years old.
• AO classification Type 44 A, B, C.
• posterior malleolus fragment measuring < 25% of the maximal A-P diameter of the tibial plafond as measured on pre-operative CT.

• Previous surgery about the ankle.
• Non-ambulatory status preoperatively.
• Ipsilateral lower extremity injury which would be expected to affect mobility status’.
• Contraindication to prone positioning during surgery.

• Subjects with an ocular tumor.
• Subjects with a family history of an ocular tumor.
• Subjects without an ocular tumor and no family history of ocular tumor who would serve as a control in specific case-control experiments.
• Ability to understand and willingness to sign the informed consent documents.

• Unable or unwilling to sign or understand the informed consent documents.
• Unwilling to participate in the research.
• Unwilling to allow genetic testing.
• Unwilling to allow samples to be sent to other institutions for testing.
• Not meeting the Inclusion Criteria.

• Adult patients (age ≥ 18 years)
• Adult patients with diagnosis of Congenital Heart Disease (i.e., Tetralogy of Fallot (TOF), Pulmonary Atresia, Coarctation of Aorta, etc.).

• Patients without research authorization.

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

• Subjects are scheduled for a clinically indicated cardiac ultrasound examination at the site.
• Subjects are over the age of 18.

Exclusion Criteria:

• Subjects under the age of 18.
• Women who are currently pregnant.
• Subjects with any known contraindications for ultrasound scanning.
• Philips employees and their family members.

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

Eligibility last updated 9/2922. Questions regarding updates should be directed to the study team contact.

• Group 1: children 5-7 months of age receiving the 3rd scheduled DTap-IPV/Hib+PCV13 dose.
• Group 2: children 10-18 months of age receiving the 1st scheduled MMR+VZV dose.
• Group 3: children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose.
• Group 4: children 0-12 years of age receiving the influenza vaccine or nasal mist.
• Group 5: children 0-12 years of age receiving the SARS-CoV-2 vaccine.
• Group 6: children in any of the above groups that were scheduled for a clinical vaccination after their first research blood collection, but it was cancelled by the provider for any reason.
• Group 7: young adults 18-21 years of age receiving the influenza vaccine or nasal mist or SARS-CoV-2 vaccine.

• History of autoinflammatory or autoimmune disease.
• History of genetic or metabolic disorder.
• History of hematological disorder.
• History of malignancy or active malignancy undergoing suppressive treatment.
• Blood donation or collection within 8 weeks of the study.
• Signs or symptoms consistent with severe infection at the time of first visit.
• Weight less than 6 kg in group 1, less than 7.5 kg for group 2, less than 12 kg for group 3 and less than 6 kg for groups 4 & 5.
• Additional vaccination within 3 weeks prior to baseline blood draw.

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

• Age 18 years of age or older.
• Able to provide informed consent.

• None.

• Provision of signed and dated informed consent form.
• Subject agrees to be compliant with study requirements and adhere to post-operative dietary and exercise recommendations for the duration of the study.
• Subjects between the ages of 22-60 years.
• If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
• Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)):
  • Pre-diabetes – Fasting plasma glucose test >100 mg/dl but ≤ 125 or oral glucose tolerance test ≥ 140 mg/dl but < 200;
  • Diabetes – Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose >126 mg/dl;
  • Hypertension – SBP > 140 or DBP > 90 or the use of an anti-hypertensive medication;
  • Dyslipidemia – Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications;
  • Sleep Apnea – A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6;
  • Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep;
  • Venous Stasis Disease – Presence or history of pretibial venous stasis ulcers;
  • Chronic Joint Disease – Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
• Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
• Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
• Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
• Subjects must be willing to possibly forego any future weight loss procedures (i.e., Vertical Sleeve Gastrectomy) given the unknown long-term effects.
• Residing within a reasonable distance from the Investigator’s treating office (~ 50 miles) and willing and able to travel to the Investigator’s office to complete all routine follow-up visits.

• History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• Large hiatal hernia (> 3 cm) by history or as determined by pre-enrollment endoscopy.
• Pancreatic insufficiency/disease.
• History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• Pregnancy or plans of pregnancy in the next 12 months.
• History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1.  Intranasal/inhaled steroids are acceptable.
• Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• Active gastric erosion, lesion, or gastric/duodenal ulcer.
• History of or current platelet or coagulation dysfunction, such as hemophilia.
• History or present use of insulin or insulin derivatives for treatment of diabetes.
• Type II Diabetes Mellitus (as defined by HgbA1c > 6.5%) for greater than 11 years at the time of enrollment.
• If smoker, plans to quit smoking in the year after enrollment.
• Portal hypertension and/or varices.
• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
• Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical/ psychological assessment.
• Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 
• Patient score > 2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI)
• Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes
• Non-ambulatory or has significant impairment of mobility (i.e., cannot ambulate for 30 minutes).
• Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH > 5.0 U/ml).
• Participating in another clinical study.
• Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• Physician’s assessment that the subject is not an appropriate candidate.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

• Patients with TJA and matched controls.

• None.

• Age ≥ 18 years old.
• At least one ambulatory visit in one of the participating study sites during the past year.
• SBP > 145 mmHg at most recent clinic visit (may be treated with BP meds already or not), as reported by the participant.
• A self-reported commitment to “work on lowering your blood pressure by 10 points or more to reduce your risk of heart attack and stroke."
• Owns a Smartphone (Android or iOS) and has an email address.
• Willing to receive text messages from the study.
• Can read/write English well enough to use English-based Smartphone apps and fill out online surveys in English.

• Has an arm circumference < 22 cm or > 42 cm.
• Owns a functioning Home Blood Pressure Monitor (HBPM) and has used it in the last 3 months.

• Male or female gender.
• Adults aged 18-100 years old.
• Isolated medial knee pain secondary to medial meniscal pathology or medial compartment osteoarthritis.
• Willingness to trial a medial knee unloader brace for symptomatic improvement.
• Ability to ambulate 100ft without an assistive device.

• No medial knee joint pain.
• Lateral knee joint pain.
• History of knee arthroplasty on affected side.
• Prior meniscal surgery.
• Prior use of a medial knee unloader brace.
• Knee xrays taken greater than 6 months prior to study enrollment.

Aims 1 and 2:

• Patients with clinically indicated contrast enhanced MRI/CT for evaluation of Crohn’s disease.
• Patients with involvement of terminal ileum.
• Patients aged greater than 18 years old.

Aim 3:

• CD patients scheduled to have surgical resection of terminal ileum.
• CD patients age above 18 years old.

• Vulnerable subjects such as prisoners and adults lacking capacity to consent.

• Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months.
• On a gluten-free diet for at least 6 months.
• Experiencing symptoms (i.e., abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea).
• Willing to maintain current gluten-free diet throughout participation in the study. 

• Refractory celiac disease or severe complications of celiac disease.
• Chronic active GI disease other than celiac disease.

all patients with a diagnosis of adrenal insufficiency at the Mayo Clinic from from 1/1/2015 to date, who gave consent to the research project

• Children and adolescents ages 12-17 years old.
• Diagnoses of any depressive or bipolar disorder.
• Ability to read the questionnaire.

• Inability to speak English.

• Patients undergoing a Whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc.) who are deemed intermediate-high risk as per our institutional protocol as shown above.
• Patients > 18 years of age with the above mentioned diagnoses.

• Negligible and low risk patients.
• All patients undergoing arterial resection.
• Age < 18 years old.
• Currently pregnant.

• Eighteen (18) years of age or older as of date on informed consent.
• Patient is able and willing to give informed consent and follow protocol procedures and comply with follow-up visit compliance.
• Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team.
• Patient is determined to be a candidate for transcatheter mitral valve repair by a heart team for both the PASCAL System and the MitraClip System; OR patient is determined to be a candidate for the PASCAL System but not the MitraClip System due to valve anatomy (these patients may qualify to participate in the single- arm PASCAL IID registry and will not be part of the randomized cohort).
• Patient must be deemed a candidate for transseptal catheterization by the site interventional operator.
• Mitral regurgitation (3+ mo to 4+) by echo (TTE or TEE) as measured by the core lab.
• Suitable valve and regurgitant jetrphology by TEE.
• Left ventricular ejection fraction (LVEF) ≥ 20%.
• LVEDD ≤ 80mm by TTE.

• Primarily degenerative MR.
• Patient in whom TEE is contraindicated or screening TEE is unsuccessful.
• Mitral valve anatomy which might limit PASCAL System or MitraClip System access, use, and/or deployment or sufficient reduction in mitral regurgitation will be evaluated on a case-by-case basis by the Central Screening Committee. Anatomic considerations including, but not limited to, the following will be taken into consideration for assignment into the roll-in, randomized, or registry cohorts or excluded altogether:
  • Insufficient mobile leaflet available for grasping the PASCAL or MitraClip System;
  • Evidence of moderate or severe calcification in the grasping area;
  • Presence of a significant cleft or perforation in the grasping area;
  • Lack of both primary and secondary chordal support in the grasping area;
  • Leaflet mobility < 8 mm;
  • Mitral valve orifice area < 4.0 cm^2.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Chronic scarred thrombi may be considered for inclusion by the core lab.
• Echocardiographic evidence of severe right ventricular dysfunction.
• Patient with refractory heart failure requiring advanced intervention (i.e., left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure).
• Recent stroke.
• Bradycardia with heart rate < 45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmia.
• Any recent percutaneous coronary, carotid, endovascular intervention, carotid surgery, or cardiac surgery.
• Recent implant or revision of any rhythm management device (i.e., pacemaker, ICD, cardiac resynchronization therapy [CRT] with or without cardioverterdefibrillator [CRT-D]).
• Tricuspid valve disease requiring surgery or severe tricuspid regurgitation.
• Other severe valve disorders requiring intervention or left ventricular outflow obstruction.
• Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, or recent myocardial infarction (per WHO definition).
• Any planned interventional cardiac procedure
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
• Recent hemodynamic instability (e.g., need for inotropic support or intra-aortic balloon pump or other hemodynamic support device).
• Known history of untreated severe symptomatic carotid stenosis (> 50% by ultrasound) or asymptomatic carotid stenosis (> 70% by ultrasound).*
• Severe COPD in which the primary mechanism of dyspnea is pulmonary disease rather than heart failure.
• Severe aortic stenosis (aortic valve area < 1.0 cm²) or severe aortic regurgitation
• Absence of CRT with a Class I indication criteria for biventricular pacing.
• Resting systolic blood pressure 160 mmHg after repeated measurements
• Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with V wave less than twice the mean of the pulmonary capillary wedge pressure.
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) or DVT/PE in the past 6 months.
• Presence of an occluded or thrombosed IVC filter that would interfere with the delivery catheter, or presence of an ipsilateral deep vein thrombosis.
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
• Severe renal insufficiency with eGFR ≤ 25 mL/min or requiring chronic renal replacement therapy.
• Concurrent medical condition with life expectancy of less than 12 months in the judgment of the investigator.
• Known bleeding or clotting disorders or patient refuses blood transfusion.
• Modified Rankin Scale ≥ 4 disability.
• Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair).
• Active systemic infection, including active endocarditis.
• Untreatable hypersensitivity or contraindication to any of the following:
  • Aspirin or Clopidogrel or Ticlopidine; OR
  • Heparin or Bivalirudin; OR
  • Warfarin, Nitinol Alloys (nickel and titanium);
  • Contrast media.
• Pregnant or planning pregnancy within next 12 months.
  • Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to procedure and be adherent to an accepted method of contraception.
• Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment.
• Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
• Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship.

* Carotid stenosis refers specifically to the internal carotid artery unless significant external carotid artery involvement is also observed.

• Mayo Clinic patients with suspected Familial Hypercholesterolemia (FH).
• Age ≥ 18 years.
• LDL cholesterol ≥ 190 mg/dl.
• Capable of providing informed consent.

• Lack of research authorization.
• Unable to provide informed consent.

• Male and female subjects between 0 and 99 years of age.
• Adult participants who are ADPKD affected.
• Pediatric participants ADPKD affected or siblings unaffected or affected unknown.
• Adult participants must have been scheduled for an MRI exam.  Concomitant MRI imaging is not required for pediatric patients under this protocol.
• Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principle investigator, to comply with all requirements of the study.

• Female subjects that are pregnant.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria for Controls:

• Healthy volunteers
  aged 18-80 years.
• Able to provide written informed consent before participating in the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Inclusion Criteria for Constipated Patients:

• Male and female volunteers aged 18-80 years.
• Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer:
  • <3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.
• Able to provide written informed consent before participating in the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria for Controls (items marked with an asterisk also apply to patients):

• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
• Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.
• Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 3rd or 4th degree perineal tear.
• Medications that are likely to alter gastrointestinal motility: e.g., opiates andanticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).
• Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.*
• Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.
• Pregnant women, prisoners and institutionalized individuals.*

• Patients who are undergoing elective direct current cardioversion, either externally or via the patient’s internal cardioverter-defibrillator.

• Patients under age 18.

• Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks.

• Pregnant patients.

• Patients who cannot provide informed consent because of cognitive dysfunction.

• Premenopausal women (18-50 years old).
• Subjects with endometriosis.

• Postmenopausal women.
• AP diameter when lying supine greater than 32 cm 
• Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
• Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)
• Pregnant