Social Determinants of Health in Hepatobiliary Cancer Patients
Hepatobiliary Cancer Patients Social Determinants
- ≥ 18 years of age with hepatobiliary cancers and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
- Newly diagnosed hepatobiliary cancers.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/2/22. Questions regarding updates should be directed to the study team contact.
Effect of breathing pattern on resting limb hemodynamics
Breathing Pattern Effect on Resting Limb Hemodynamics
- 18 years of age and older.
- Without current, confounding cardiorespiratory, metabolic, or musculoskeletal conditions.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
• The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection.
• Males and females age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 28 days prior to registration.
• Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0).
• NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
• NOTE: Staging will be according to the AJCC 8th edition.
• Pathological tumor size must be 1.0
•4.0 cm in greatest dimension.
• Surgery for this lung cancer must be completed at least 28 days prior to registration.
• Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. If prior PD-L1 results with Dako 22C3 antibody are not available from a CLIA-accredited laboratory, subjects must be able to provide 5µm x 4unstained slides for prospective analysis to be used for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H&E slides from current diagnosis for future NGS and/or other genetic analyses.
• Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
• Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For subjects randomized to the pembrolizumab arm: If there is > 72 hours between the screening test and C1D1, another pregnancy test (urine or serum) must be performed and must be negative before the subject may start C1D1.
• NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.1.4 for definitions.
• NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• 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) OR
• A WOCBP who is using a highly effective contraceptive method (failure rate of <1% per year), or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study drug. See contraceptive guidance in Section 5.1.4 of the protocol.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
• Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV.
• Patients with tumors that are known to harbor actionable EGFR mutations.
• Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
• Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
• Has had an allogenic tissue/solid organ transplant.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of Human Immunodeficiency Virus (HIV). Note: HIV testing is not required unless mandated by local health authority.
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: Hepatitis B and Hepatitis C testing is not required unless mandated by local health authority.
• Has active TB (Bacillus Tuberculosis) infection.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Shared decision making for kidney transplant candidates to plan for an organ offer decision
Donor Plan Donor Call Tool Evaluation to Promote Shared Decision Making
- Candidate on the kidney transplant waiting list for more than 3 months..
- 18 years of age or older.
- English-speaking.
- Non-English speaking.
- < 18 years of age.
- Patients who choose to opt out of research.
- Unable to provide informed consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/6/23. Questions regarding updates should be directed to the study team contact.
High-dose Hydroxocobalamin (Vitamin B12a) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
High-dose Hydroxocobalamin (Vitamin B12a) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
- Any patient for whom we are able to obtain consent prior to their procedure or after their procedure in the intensive care unit.
- Patient must have a PA catheter, or a CCO/Flo Trak for the procedure.
- Is presenting for a procedure in which CPB will be required.
- Is considered high risk for VS.
- Patient considered to be at high risk for the development of VS will be identified per the guidelines developed by Levin et al. This includes any patient:
- With pre-CPB vasopressor requirement(s); or
- On pre-operative ACE, or beta-blocker or calcium channel blocker therapy; or
- With a euroSCORE > 6; or
- Presenting for pericardiectomy, aneurysm surgery, LVAD surgery or heart transplant, CABG or valve surgery other than a single mitral valve repair.
- Has no contraindications to arterial line or PA catheter placement
- Patient must fall into the defined parameters below for the majority of measurements over a 30 minute period (ex: 3 out of 5 measurements or 6 of 10, etc.):
- Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with VS within 24 hours of coming off CPB;
- “High-dose vasopressor” will be defined as:
- Norepinephrine infusion ≥ 0.1 mcg/kg/min; and/or
- Dopamine infusion ≥ 15mcg/kg/min; and/or
- Epinephrine infusion ≥ 0.1mcg/kg/min; or
- Norepinephrine equivalent infusion of ≥ 0.1mcg/kg/min.
- “Hypotension consistent with VS” will be defined as:
- MAP< 75 mmHg via arterial line monitor.
- Cardiac index > 2.3L/min/m^2 via PA catheter monitor.
- If at the time study drug arrives, the patient who previously met criteria has fallen out, they must once again meet requirements only one time before the drug is given.
- Age < 18 years old.
- Known pregnancy or patients without a documented pregnancy test if not menopausal.
- Known prior anaphylactic or allergic reaction to B12a.
- CKD stage 4 or worse (GFR < 30 ml/min) before study drug administration.
- ECMO (extracorporeal membrane oxygenation) or IABP (intra-aortic balloon pump)prior to study consent and post cardiopulmonary bypass.
- Patients currently on cardiopulmonary bypass.
- Circumstance for which the safety of the patient could be jeopardized by continued adherence to the study protocol.
Eligibility last updated 1/11/22. Questions regarding updates should be directed to the study team contact.
Assessing Renal Health in Patients with Chronic Liver Disease with Multiparametric Hepatorenal MRE/MRI (Hepatorenogram) (Magnetic Resonance Elastography (MRE))
Liver and Kidney Magnetic Resonance Elastography Study
- Primary liver diseases.
- Diagnosis of suspected kidney function insufficient with laboratory test.
- Age ≥ 18 years.
- Patients with kidney congenital diseases, such as renal agenesis, hypoplasia, horseshoe kidney, abnormal location kidney, etc.
- Patients with transplant kidney.
- Patients with HIV infection (lower immune activity).
- History of liver transplantation or hepatic resection.
- Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, a deep brain stimulator, and severe claustrophobia.
- Women who are pregnant or breastfeeding.
- Any severe medical condition that, in the opinion of the Principal Investigator, would serve as exclusion criteria for study enrollment.
Disparities in Liver Cancer in Southeast Asian Americans: Interviews about Social Determinants of Health
Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities
- Patients ≥ 18 years of age with Hepatocellular Carcinoma (HCC) and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
- Diagnosis of HCC.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/23/22. Questions regarding updates should be directed to the study team contact.
Geniculate Artery Embolization for Osteoarthritis
• Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
• Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
• Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
• Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
• Patients who are willing to comply with regular follow up during the 12 month follow-up period
• Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
• Patients with WOMAC Score >=6 in at least 2 categories
• Patients with a weight >250 pounds
• Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
• Patients with known significant peripheral arterial disease precluding common femoral catheterization
• Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• Patients with diabetes who have a hemoglobin A1C of >9%
• Patients who have undergone previous lower extremity embolization
• Patients with uncontrolled emotional disorders per patient medical history
• Patients with chronic pain syndrome or currently under a pain contract
• Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
• Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
• Patients with an abnormal INR (>1.5).
• Patients with a platelet count <50x109/L.
• Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
• Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
• Patients who are pregnant or intend to become pregnant within 6 months of the procedure
• Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
• Patients with a life expectancy <60 months
• Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
• Patients with contraindications to medical and physical rehabilitative treatments of OA
• Patients with known advanced atherosclerosis
• Patients with known current or previous lower extremity fistula
• Patients with rheumatoid arthritis or seronegative arthropathies
• Patients with prior ipsilateral knee surgery.
• Patients with WOMAC Pain Scale < 6
• Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening
Biorepository for Acute Leukemia Research
Biorepository for Acute Leukemia Research
- Specimens will be collected from all consenting adults (age ≥ 18 years) with confirmed or suspected AML or ALL that represents a new diagnosis, a recurrence, or a progression from well recognized harbingers of acute leukemia.
Home Pulmonary Rehabilitation for COPD
Home Pulmonary Rehabilitation for COPD
Inclusion Criteria
- Clinical diagnosis of COPD
- Age ≥40 years
- Current or previous smoker (≥10 packs per year)
- Confidence in using the proposed PR system
- English or Spanish language fluency
Exclusion Criteria
- Unable or unwilling to do Rehabilitation due to physical conditions
Stories for Change: Cancer Prevention
Cancer Prevention: Stories for Change in Hispanic Community
- Hispanic adults (age 18 or older).
- Speak Spanish fluently.
- Identify as a survivor or co-survivor of breast, cervical, or colorectal cancer.
- Have received all the recommended COVID-19 vaccinations for their age group (we will be in close quarters during the DST workshop and want to protect any participants who may be immunocompromised after receiving cancer treatment).
- People younger than 18 years old.
- Non-Hispanic individuals.
- Hispanic individuals who do NOT speak Spanish.
- Individuals who do NOT identify as a survivor or co-survivor of breast, cervical, or colorectal cancer.
- Individuals who have not received a COVID-19 vaccination.
Eligibility last updated 8/2/22. Questions regarding updates should be directed to the study team contact
Initial Outcomes of 2-day Pediatric Pain Rehabilitation Program
Pediatric Pain Rehabilitation Program
- Age 12-25
- Patients in the 2-day Pediatric Pain Rehabilitation Program
- Don’t speak English as their first language
Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing
A Study to Assess Pulmonary Congestion During Cardiac Hemodynamic Stress Testing
- All adult patients (≥ 18 years old) who are referred for invasive hemodynamic assessment of chronic dyspnea.
- Patients who have the capacity to understand and consent for the research study.
- Patients with known interstitial lung disease or pulmonary fibrosis.
In Vivo Development of Sodium Magnetic Resonance Imaging Technology
Sodium MRI Pilot
- Men and women.
- Ages ≥ 18 to ≤ 65 years old.
- Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
- Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- No contraindication to MRI.
- No implanted devices within the body (shunts, clips, plates, etc.).
- No dental braces or retainer wires.
Evaluation of 7T Magnetic Resonance Imaging in Multiple Sclerosis
A Study to Evaluate 7T Magnetic Resonance Imaging in Multiple Sclerosis
- Age ≥ 18 years old.
- Capable of giving consent.
- Established diagnosis of Multiple Sclerosis according to McDonald Criteria (2018). Patients may be diagnosed with any of the conventional phases of MS, primary progressive, relapsing remitting, secondary progressive etc.
- Willing to participate in a 7T MRI examination within a few days of their clinical 3T or 1.5T examination.
- Age < 18 years old.
- Any metallic implant, device implant, ventriculoperitoneal shunt, cardiac valve, pacemaker which would constitute a contraindication to 7T imaging.
- Previous craniotomy.
- Permanent facial makeup (for brain scanning).
- Suffer from claustrophobia.
- Pregnancy.
- Fever / elevated temperature.
Normative Biomechanical Measures of Reaching in Able-Bodied Adults
Reach Normal Controls
- 20-59 years of age at time of enrollment
- Failure to give consent or follow simple commands
- Score of 7 or above on the QuickDASH Outcome Measure
- Score of 5 or above on the Oswestry Low Back Disability Questionnaire
- Score of 76 or below on the Lower Extremity Functional Scale
- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis,
fibromyalgia)
- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional
vertigo)
- Insufficient active range of motion of bilateral shoulders or hips that results in
inability to perform forward or lateral reaching tasks
- Any illness or condition which, based on the research team's assessment, will
compromise the patient's ability to comply with the protocol, patient safety, or the
validity of the data collected during this study
Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.
Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease (INTERCEDE)
Gonda Vascular Center Vascular Anomalies Tissue Repository
A Study to Establish a Vascular Anomalies Tissue Repository
- Male or female patients, aged 0 to 100 with a vascular tumor or malformation.
- Able to provide Informed Consent (or parental ability to provide informed consent if under age 18).
- Have 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.
Screening for PEripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) (SPEC-AI)
Screening for PPCM Using AI
- Women of reproductive age, 18 – 49 years.
- Seen for clinical care by an obstetrician/gynecologist or cardiologist; advanced practice nurse or physician assistant working in the selected practice.
- Complex congenital heart disease (single ventricle physiology, complex cardiac surgery or significant shunts with cardiac structural changes).
- Significant conduction abnormalities.
Motion Compensation Study
A Motion Compensation Study
- Subject is at least 18 years of age.
- Subjects is indicated for a routine ultrasound examination at the site, including with or without examination with contrast.
- Subject is willing and capable of providing informed consent and participating in this study.
- Subjects who are pregnant will be excluded from the study.
- Subjects with a limited capacity to consider being scanned on an additional ultrasound system will be excluded.
Pulmonary Hypertension Association Registry (PHAR)
A Study to Develop a Pulmonary Hypertension Association Registry (PHAR)
- New patients to a PHA Care Center with either newly diagnosed or established PAH or CTEPH (within 6 months of first outpatient visit at the PHCC).
- Informed consent for data to be abstracted and included in the PHAR provided by the patient or guardian.
- Able to understand and speak either English or Spanish.
- Any exception to the Inclusion Criteria above.
Familial Hypercholesterolemia Identification REgistry (FHIRE) (FHIRE)
A Study to Develop A Familial Hypercholesterolemia Identification REgistry (FHIRE)
- 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.
Rochester Older Adult Registry (ROAR) (ROAR)
A Study to Establish a Rochester Older Adult Registry (ROAR)
- 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.
- 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).
A Single-Use Duodenoscope in a Real-World Setting (CIS-018)
A Single-Use Duodenoscope in a Real-World Setting
- Subject is ≥ 18 years old.
- Subject is indicated and scheduled for an elective, non-emergent ERCP.
- Subject is willing and able to give informed consent and HIPAA authorization.
- Subject has altered pancreaticobiliary anatomy including:
- Billroth II;
- Roux-en-Y gastric bypass;
- Loop gastric bypass;
- Post-Whipple;
- Roux-en-Y hepaticojejunostomy.
- Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
- Subject has one or more of the following severe co-morbid conditions:
- Morbid obesity (BMI ≥ 40);
- Unstable cardiopulmonary conditions;
- Severe and uncorrectable coagulopathy;
- Severe and uncorrectable thrombocytopenia.
- Subject has clinically significant esophageal, pyloric or duodenal strictures.
- Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
- Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
- Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.
Sleep Health, Symptoms, and Functional Performance in People With Inflammatory Bowel Disease (Sleep Health in IBD)
Sleep Health in Inflammatory Bowel Disease
Inclusion Criteria:
- Age ≥ 18 and < 60 years.
- Diagnosed with IBD (Crohn’s disease, ulcerative colitis, or indeterminate colitis).
- Living in the United States.
- Patients with current ostomies or ileal pouches.
- Currently in a medication trial for non-FDA approved medication for IBD.
- Who are blind
- With current cancer treatment.
- Pregnant or breastfeeding.
- Work night or rotating shifts.
- Diagnosed with severe psychiatric (bipolar disorder, schizophrenia).
- Neurological conditions affecting the non-dominant hand (due to actigraphy monitoring).
- Those who do not read and write in English
- Those without internet access or email address (due to use of internet surveys).
- Note: We will delay data collection for at least four weeks for those who have had surgery, and 2 weeks for those who have traveled across a time zone or due to daylight savings.
Eligibility last updated 6/9/22. Questions regarding updates should be directed to the study team contact.
Individualized Medicine Biobank for Mitochondrial Diseases
Individualized Medicine Biobank for Mitochondrial Diseases
- Age birth-100 years, male or female, any race/ethnicity
- Potential participant shall have a confirmed diagnosis of a mitochondrial disease or a suspected diagnosis based on a review of clinical history by a Mitochondrial Disease Biobank working group member using the clinical criteria listed in the table below
- Selected participants shall have at least two documented conditions contained within the minor clinical criteria
- Minor Criteria
- Symptoms compatible with a mitochondrial defect
- Smaller numbers of RRF or widespread electron microscopy abnormalities of mitochondria
- Antibody-based demonstration of an mito defect or residual activity of an mito complex 20%–30% in a tissue, 30%–40% in a cell line, or 30%–40% in >2 tissues
- Fibroblast ATP synthesis rates 2–3 SD below mean, or fibroblasts unable to grow in galactose media
- Nuclear or mtDNA mutation of probable pathogenicity
- One or more metabolic indicators of impaired metabolic function
- Minor Criteria
- OR one condition in the major criteria with evidence of a condition in the minor criteria, will be considered for inclusion of a participant of appropriate age
- Major Criteria
- Multi-systemic symptoms characteristic of mito disorder
- Progressive clinical course with episodes of exacerbation
- A family history strongly indicative of an mtDNA mutation
- Exclusion of other metabolic or non-metabolic disorders
- >2% ragged red fibers (RRF) in skeletal muscle
- Cytochrome c oxidase negative fibers (>2-5%) or residual activity of a mito complex <20% in a tissue; <30% in a cell line, or <30% in >2 tissues
- Fibroblast ATP synthesis rates >3 SD below mean
- Nuclear or mtDNA mutation of undisputed pathogenicity
- Major Criteria
- 1st-degree relatives of affected participants (described above) are also invited to participate in the project.
- In addition, samples from participants with one of the following mitochondrial disease diagnosis will be included:
- Alpers’ progressive sclerosing poliodystrophy
- Barth syndrome
- CPEO
- Dominant optic atrophy
- Friedriech’s Ataxia
- Hereditary paraganglioma
- Hereditary spastic paraplegia
- Kearns-Sayre syndrome Leber hereditary optic neuroretinopathy
- Leigh and Leigh-like Syndrome
- MELAS
- MERRF
- NARP
- Pearson syndrome
- Wolfram syndrome
- Mitochondrial fatty acid oxidation disorder
- Urea cycle defect
- Unwilling to provide informed consent
- Unwilling to consent to providing biospecimens to be stored in the biobank for an indefinite amount of time and to be used in future research studies of as yet unknown design
- Does not have a diagnosis of mitochondrial disease or clinical symptoms that are indicative of a potential mitochondrial disease as determined by a chart review by at least one Individualized Medine Biobank for Mitochondrial Disease working-group member
Suturing Pattern for Endolumenal Stenting Procedures
Suturing Pattern for Endolumenal Stenting Procedures
- Non-vulnerable adults who are receiving an endoscopically- placed stent for any indication.
- Pregnancy.
- Imprisoned individuals.
- Institutionalized patients.
Bioengineered Cardiac Tissue for Cardiomyopathy Analysis
Bioengineered Cardiac Tissue for Cardioyopathy Analysis
- Patients age 0-100 years.
- Clinically diagnosed cardiomyopathy.
- Unaffected biological family members.
- Uunrelated healthy controls.
- IRB# 13-00008 participants.
-
Allergy to subcutaneous lidocaine, bupivicaine, or epinephrine.
Eligibility last updated 11/22/21. Questions regarding updates should be directed to the study team contact.
Prehabilitation for Advanced Ovarian Cancer Patients
Prehabilitation
- Females, age 18 years or older.
- Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis.
- Suspected Stage IIIC or IV disease based on clinician staging and imaging.
- Curative intent treatment with platinum-based chemotherapy.
- Planned surgical intervention at some point during treatment course.
- Ability to read English.
- No diagnosed severe cognitive impairment.
- Ability to provide informed consent.
- Ability to utilize technology to watch online modules for the Resilient Living Program.
- Females under 18 years of age.
- Hemiplegia or paraplegia.
- Current pregnancy.
Validation of Software to Anonymize Patient Faces from Cranial MRI
Study to Validate Software Used to Make Patient Faces Anonymous from Cranial MRI
- Stratified balance of age/sex.
- Standard MRI medical/safety exclusion criteria.