Establishment and validation of a new protocol and normative values for the evaluation of gastric emptying and gastric accommodation in bariatric surgery patients
Study to Evaluate Gastric Emptying and Accommodation in Bariatric Surgery Patients by Establishing and Validating a New Protocol and Normative Values
- Able to provide written informed consent prior to any study procedures.
- Willing and able to comply with study procedures.
- No medical problems or chronic diseases for healthy volunteers.
- No prior diagnosis of gastroparesis in bariatric surgery groups.
- Body mass index of 18-27 kg/m^2 for healthy volunteers.
- Body mass index of 18-50 kg/m^2 for bariatric surgery groups; type 2 diabetes is permissible as long as there are no exclusion criteria.
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to radiation exposure.
- Ability and willingness to eat all components of the test meal.
- Unable or unwilling to provide informed consent.
- Unable or unwilling to comply with study procedures.
- Prior alteration of gastric anatomy.
- Known or suspected gastroparesis.
- Use of drugs known to alter gastrointestinal function including opiates, GLP1 agonists and analogs and medications known to affect gastric emptying.
- History of recent surgery (within 60 days of screening) in the healthy volunteer group.
- Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes (HbA1c >12%), etc.
- Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator.
- Acute GI illness within 48 hours of initiation of the baseline period.
- Females who are pregnant or breastfeeding.
- History of excessive alcohol use or substance abuse.
- Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study.
- Body weight more than 600 lbs.
Bronchiectasis Research Registry
Bronchiectasis Research Registry
- Over the age of 18
- non-CF Bronchiectasis
- Nontuberculosis Mycobacteria (NTM)
- Under the age of 18
- CF Bronchiectasis
Celiac Disease Registry
Celiac Disease Registry
- Age greater than 3 years
- All subjects will be included even those with a suspected diagnosis of celiac disease and/or dermatitis herpetiformis.
- Patients with
- Collagenous sprue
- Idiopathic sprue
- Lymphocytic enterocolitis
- Idiopathic enteropathies
- Collagenous gastritis
- Whipple’s disease
- Other miscellaneous inflammatory disorders of the small intestine
- Vulnerable population
Medtronic Product Surveillance Registry (PSR)
Product Surveillance Registry
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with an eligible Medtronic product
- Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
- Patient who is, or will be, inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository- HS PROGRESS
Hidradenitis Suppurativa Registry
- Male or female, ≥ 10 years of age.
- Diagnosis of Hidradenitis Suppurativa (HS) by a dermatologist or practitioner experienced in making a diagnosis of HS.
- Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
- Immediate family members (for saliva and genetics data).
- Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.
COPD Hospitalization Registry
COPD Hospitalization Registry
- Hospitalization within 3 months for COPD related causes (exacerbation (including COVID) and/or pneumonia)
- Adults 40 years of age or older..
- Individuals not able to be reached by telephone.
Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.
Validation of Auto Registry and Integration of Ultrasound into Procedure
Study to Validate Auto Registry and Integration of Ultrasound into Procedure
- Subject is at least 18 years of age.
- Subject is indicated for an image fusion study, either for biopsy, ablation or follow-up based on prior MR or CT findings, as normal standard of care.
- Subject is willing and capable of providing informed consent and participating in this study
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Subjects who are pregnant will be excluded from the study.
Scoliosis Outcomes Database Registry (AIS)
A Study to Establish An Adolescent Idiopathic Scoliosis Outcomes Database Registry
Inclusion Criteria
•Database Registry:
- Patients aged ≤ 26 years who present with a curve large enough that a definitive fusion for idiopathic scoliosis would be considered an option.
- Male or female.
- Diagnosis of idiopathic scoliosis for which definitive fusion surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
- Curve cobb of any magnitude – operative range.
- Spina bifida Oculta is permitted.
- Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
- Non-operative idiopathic scoliosis patients:
- Aged ≤ 26 years, male or female, curve cobb of ≥40º, whom elected not to proceed with surgery; or
- Aged ≤ 26 years, male or female, Curve cobb ≥ 30º and approaching skeletally mature (defined as Age: girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 or sanders ≥7).
Execlusion Criteria
•Database Registry:
- Prior spinal surgery.
- 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.
- Unable or unwilling to firmly commit to returning for required follow-up visits.
Adolescent Autonomic Dysfunction Registry and Biobank
A Study to Create an Adolescent Autonomic Dysfunction Registry and Biobank
- Male or female patients with presenting symptoms suggestive of Adolescent Autonomic Dysfunction.
- Able to provide Informed Consent (or parental ability to provide informed consent if under age 18).
- Has a Mayo Clinic Number.
- Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent, non-English speaking) or whose parents are unable to provide informed consent if under age 18.
Popliteal Artery Entrapment Syndrome (PAES) Prospective Registry (PAES)
A Study to Create a Registry for Popliteal Artery Entrapment Syndrome
- Patients diagnosed with popliteal artery entrapment syndrome (PAES) and undergo surgical management.
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Medically managed PAES.
Type 1 and Type 2 Diabetes registry
Type 1 Diabetes registry
- Clinical diagnosis of type 1 diabetes.
- Refusal of permission to use medical records for ongoing research.
Type 1 and Type 2 Diabetes registry
Type 1 Diabetes registry
- Clinical diagnosis of type 1 diabetes.
- Refusal of permission to use medical records for ongoing research.
Cavernous Malformation Prospective Registry (cav mal)
Cavernous Malformation Prospective Registry
- Individuals identified radiographically or pathologically with an intracranial or intraspinal cavernous malformation will be included in this study
- Electronic medical record states they were told of the finding of a cavernous malformation
Cystic Fibrosis Patient Registry
Cystic Fibrosis Patient Registry
- All individuals with Cystic Fibrosis (CF) or individuals with CF related disorders (e.g., CRMS, CFTR-related disorders)
- Pregnant woman, fetuses or neonates
Airway Stenosis Specimen Registry
Airway Stenosis Specimen Registry
- Subject must be > 18 years of age
- Presumed or known or screening of airway diseases of the head, neck and lungs generating airway stenosis (which includes but not limited to the following: idiopathic scarring and inflammation, trauma, head and neck neoplasms (masses/nodules) malignant or benign, subglottic diseases, infections, Head and Neck malignancies metastatic to other organs and other Airway diseases.
Thoracic Outlet Syndrome Registry
Thoracic Outlet Syndrome Registry
- Patients referred to the Gonda Vascular Center Thoracic Outlet Syndrome Clinic.
- None
Aortic, Peripheral & Venous (APV) Product Surveillance Registry Platform Base Clinical Investigation
Product Surveillance Registry-APV
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- Patient has, or is intended to receive or be treated with, an eligible Medtronic product.
- Patient is consented within the enrollment window of the therapy received, as applicable.
- Patient who is, or is expected to be, inaccessible for follow-up.
- Patient is excluded by local law.
- Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
Cardio-Oncology Clinic Registry
Cardio-Oncology Clinic Registry
- Patients referred to the Mayo Clinic cardio-oncology clinic.
- Adults ≥ 18 years old.
- Individuals < 18 years old.
Global Cardio Oncology Registry (G-COR) (G-COR)
Global Cardio Oncology Registry
- New cardio-oncology consultation for breast cancer patients; or
- New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients; or
- New cardio-oncology consultation for acute or chronic leukemia patients; or
- New cardio-oncology consultation for multiple myeloma or AL amyloidosis; or
- New cardio-oncology consultations for immune check-point inhibitors cardiac
evaluation.
- All patients have to be 18 years old or older.
- Cardio-oncology patients who have previously had cardio-oncology evaluation and follow
up by the investigators.
- Minors less than 18 years old.
- Inability or unwillingness to consent to participate.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.
Thoracic Specimen Registry
A Study to Collect Thoracic Specimens to Develop a Thoracic Specimen Registry
- Subject must be > 18 years of age
- Presumed or known or screening of Thoracic Diseases (which includes but not limited to the following: thoracic neoplasms (masses/nodules) malignant or benign, interstitial lung diseases (ILD), chronic obstructive pulmonary disease (COPD), thoracic infections, thoracic malignancies metastatic to other organs, other cancers metastatic to the thoracic cavity.
SLIP II REGISTRY
A Study of Comparing Patient Outcomes and Satisfaction with or without Expert Panel Review before Making a Final Decision about Surgery for Grade I Degenerative Lumbar Spondylolisthesis
- Patients at least 18 years of age with symptomatic lumbar spinal stenosis and single-level grade I degenerative spondylolisthesis (3 –14 mm).
- Symptomatic spinal stenosis will be defined as radicular and/ or back pain either induced or aggravated by activity and relieved by rest in a patient with either moderately
- Serious medical illness (ASA Class IV or higher)
- Spondylolysis, multilevel spondylolisthesis, or high grade spondylolisthesis
(Grade II or greater than 14 mm) - Subjects will be enrolled by participating spine surgeons who are investigators in the study. These patients will be identified within the existing practice of each surgeon. There will be no advertising or any effort to recruit patients into the study from outside the practice of a study surgeon investigator.
Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
A Study to Establish a Multi-focal Registry for Ground Glass Opacities
- ≥ 18 years of age.
- Have two or more Ground Glass Opacities (GGO) on CT imaging.
- GGOs must be ≤ 3 cm in the greatest dimension.
- GGOs must be greater than half ground glass.
- < 18 years of age.
Evaluation of the Natural History and Management of Cardiac Sarcoidosis: the Mayo Cardiac Sarcoid Registry
the Mayo Cardiac Sarcoid Registry
Adults evaluated in any Cardiology clinic with the diagnosis of probable or definite sarcoidosis.
Patients declining to participate in the prospective registry.
Surveillance HeartCare® Outcomes Registry (SHORE) (SHORE)
Surveillance HeartCare® Outcomes Registry
- 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.
- Patients who are pregnant at the time of blood draw.
Mayo Clinic Community Research Registry (MCCRR)
Mayo Clinic Community Research Registry
- Adult (18-90), male/female/other.
- Self-reported racial/ ethnic minority.
- Internet access via mobile device and/or computer/tablet.
- Able to read and write in English or Spanish.
- Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature.
- Under the age of 18 years old.
- Identified as non-underrepresented racial/ethnic minority or medically underserved minority.
- Unable to read and write in English or Spanish.
Eligibility last updated 11/8/21. Questions regarding updates should be directed to the study team contact.
Prospective Study of Adrenal Disorders: Clinical Registry, Imaging Analysis and Biomaterial Collection
Clinical Registry, Imaging Analysis and Biomaterial Collection
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Patients with:
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adrenal mass of any etiology
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steroidogenesis defect ( examples: 21OH congenital hyperplasia, 11 beta congenital hyperplasia)
-
primary or secondary adrenal insufficiency
-
Cushing’s syndrome due to pituitary or ectopic ACTH production
-
Inadequate glucocorticoid, mineralocorticoid or androgen axis of unknown etiology
-
Healthy individuals
-
Patients seen for problems other than mentioned above and willing to contribute biomaterial
-
-
Age 18-99 years
Exclusion Criteria: -
Age <18 years
Observational Registry study of Patients with Paroxysmal Nocturnal Hemoglobinuria treated with Pegcetacoplan
Paroxysmal Nocturnal Hemoglobinuria treated with Pegcetacoplan Patient Registry
- Enrolled in the core PNH registry or has PNH confirmed by high-sensitivity flow cytometry who will enroll in the core PNH registry.
- Currently receiving pegcetacoplan treatment.
- Patient or legally authorized representative are willing and able to provide written informed consent to participate in the pegcetacoplan PNH registry in a manner approved by the IRB/IEC and local regulations.
- Participating in an interventional PNH clinical trial.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MacTel Study
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MacTel Study
Eligibility Criteria
Registry Probands
- Must have a confirmed clinical diagnosis of MacTel Type 2.
- Must be 18 years of age or older.
- Should not have diabetic retinopathy with 10 or more microaneurysms.
- Have no confounding ocular conditions that may now or in the future complicate the evaluation of MacTel Type 2.
- Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form’s contents and sign the informed consent.
Family Members
- Family members of any proband who are of the age approved by the IRB/IEC at the clinic where the family member will be seen may consent for screening. Halfsiblings are allowed to participate.
- If confirmed to be affected with MacTel Type 2, the Family Member may consent to be enrolled in the registry.
Pompe Disease Registry Protocol
Spontaneous Intracranial Hypotension Registry
A Clinical Registry of Spontaneous Intracranial Hypotension
- Study subjects will be patients who meet the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
- Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
- Adult patients ≥ 18 years old.
- Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy), inability to provide informed consent.
- Expected inability to complete the follow-up assessment.
- Current pregnancy.
Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.