A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
A Study to Evaluate Oral Tamoxifen vs. TamGel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
- Willing to return to enrolling institution for follow-up
- Willing to complete required testing
- Ability to complete questionnaire by themselves or with assistance
- Female (sex that was assigned at birth)
- Ipsilateral intact breast with histology confirmation of atypical ductal or lobular
hyperplasia, or LCIS, within the last 12 months, whether surgically excised or not.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Willingness to agree to use ONE effective form of birth control (abstinence is not an
allowed method) prior to study entry and for the duration of study participation, and
for 2 months following the last dose of study medications. Effective birth control
methods are: copper IUD [intrauterine device], diaphragm/cervical cap/shield,
spermicide, contraceptive sponge, condoms. Women of childbearing potential must have a
negative pregnancy test within five days before starting study medications. Should a
participant become pregnant or suspect she is pregnant while participating in this
study; the participant should inform the study physician immediately.
- Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e.
tanning beds) for the duration of the study.
- Participants must have acceptable organ and marrow function as defined below within 30
days of randomization: judged by treating physician's evaluation of baseline
laboratory data.
- Negative urine pregnancy test, if of childbearing potential. and / or FSH to verify
menopausal status.
- Clinically suspicious mass/lesions Breast cancer in the past 5 years.
- Prior thromboembolism within last 5 years (history of varicose veins and superficial
phlebitis is allowed) Current pregnancy or lactation History of other prior breast
cancer-specific therapy within the previous 2 years (chemotherapy, anti-HER2 agents,
endocrine agents, everolimus, CDK4-6 inhibitors).
- Cytotoxic chemotherapy for any indication in last 2 years.
- Prior use of SERMS or AIs including tamoxifen, raloxifene, anastrozole, letrozole, or
exemestane for prevention or therapy within 5 years.
- Exogenous sex steroid, including oral contraceptive pill use within 1 month prior to
research core needle biopsy (CNB).
- Use of vaginally administered estrogens and hormone coated IUD such as Mirena is
permitted History of any prior ipsilateral breast radiotherapy. Previous unilateral
radiation of the contralateral side is allowed.
- Skin lesions on the breast that disrupt the stratum corneum (eg eczema, ulceration).
- History of endometrial neoplasia
- Current smoker. Cessation for at least 6 weeks
- Current users of potent inhibitors of tamoxifen metabolism. The potent inhibitors of
tamoxifen metabolism are: bupropion, cinacalcet, fluoxetine, paroxetine, quinidine.
- Participants may not be receiving any other investigational agents within 90 days of
enrollment or during this study.
- History of allergic reactions to tamoxifen.
- Uncontrolled intercurrent illness that in the judgement of the treating physician
would make them unsuitable for study participation
- Anticoagulation meds and clinical concern for discontinuing meds for study research
biopsy.
- Identification of a clinically suspicious mass on examination.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/12/22. Questions regarding updates should be directed to the study team contact.
Mayo MRI White-Matter-Nulled Imaging Study (START MRI)
Mayo MRI White-Matter-Nulled Imaging Study
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, 18 years of age or older.
- In good general health as evidenced by medical history but may include a diagnosis of epilepsy.
- Volunteers who are confirmed to have temporal lobe epilepsy based on established medical history and have established outpatient epilepsy care within the Mayo Clinic Health System.
- Participants with a contraindication to MRI. Such contraindications include, but are not limited to: pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, tattoos, implanted electronic infusion pumps or any other condition that would interfere with the MRI, a stent somewhere in the body, a history of allergic reaction to any metals.
- Participants who have structural anatomical legions outside the medial temporal lobe.
- Pregnancy or lactation.
- Participants who report previous experience with claustrophobia, anxiety and/or vertigo when moved inside the scanner.
- Febrile illness within the last thirty days.
- Treatment with another investigational drug or other intervention within the last thirty days.
- Subjects incapable of giving informed written consent.
- Participants in the prisoner population.
Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.
Afrezza® INHALE-1 Study in Pediatrics (INHALE-1)
• Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB)
• Subjects ≥4 and <18 years of age
• Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
• Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
• Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
• Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
• Access to stable WiFi connection
• HbA1c ≥7.0% and ≤11%
• Average prandial dose of insulin ≥2 units per meal
• Utilized CGM for ≥70% of the time over a consecutive 14-day period preceding randomization
• History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
• Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
• History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy), or likely need for specific treatment for diabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year
• FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung Function Initiative (GLI) value
• Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of age would make the subject ineligible
• For subjects <8 years of age who are unable to achieve an acceptable FVC reading, FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make the subject ineligible
• Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
• Inability or unwillingness to perform study procedures
• Exposure to any investigational product(s), including drugs or devices, in the past 30 days
• Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism and current or anticipated acute uses of glucocorticoids or weight loss medications, with the exception of metformin and/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior to enrollment) in subjects with T2DM
• Use of antiadrenergic drugs (e.g., clonidine)
• Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
• Current uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
• Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
• Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive urine cotinine test
• Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential, sexually active and not using adequate contraceptive methods as required by local regulation or practice
• An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
• An episode of DKA requiring hospitalization within the last 90 days prior to screening
Tissue characteristics of early vascular aging
Early Vascular Aging in Patients With Early Coronary Artery Disease
- Routine coronary angiography.
- Age ≥ 18 years.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/22/23. Questions regarding updates should be directed to the study team contact.
Magnetic Resonance Elastography of Cognitive Impairment
Magnetic Resonance Elastography pf Cognitive Impairment
- Human subjects will be recruited for the project from the Mayo Alzheimer’s Disease Research Center.
- Cognitively normal elderly patients.
- Patients with mild cognitive impairment.
- Patients with Alzheimer’s disease.
- Agse 18 to 100 years of age.
- Their dementia will not be due to other medical or psychiatric problems.
- Exclude individuals with contraindications to MRI scanning such as a cardiac pacemaker, the presence of intraocular or intracranial metallic objects and MRI incompatible devices.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/19/23. Questions regarding updates should be directed to the study team contact.
Pharmacokinetic profile of rosemary extract supplement
Rosemary Extract Supplement Pharmacokinetic
- Healthy subjects aged between 25 and 55 years.
- Non-smoker.
- Body Mass Index (BMI) between 20 and 30 kg/m^2.
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or
infectious disease.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/7/23. Questions regarding updates should be directed to the study team contact.
Compassionate Use of 3,4 Diaminopyridine in Patients with Congenital Myasthenic Syndrome
Compassionate Use of 3,4 Diaminopyridine in Patients with Congenital Myasthenic Syndrome
- Patients with documented CMS (based on clinical and electrodiagnostic criteria, and in some cases molecular genetic and microelectrode studies performed on muscle biopsy specimens)
Creation of a Longitudinal Biospecimen Repository from Patients with ANCA-associated Vasculitis
Creation of a Biospecimen Repository from Patients with ANCA-associated Vasculitis
- Any patient with a diagnosis of AAV.
- Potential subjects will be identified on the basis of their being scheduled for evaluation in the pulmonary vasculitis clinic.
- All patients scheduled in the clinic will be recruited, either in advance of their appointment (via telephone contact or posted written materials) or at the time of their clinical visit (via a face-to-face meeting).
- Community outreach will not be feasible for this rare disease, but again, all patients scheduled in the pulmonary vasculitis clinic are eligible for recruitment.
- Patients admitted to the hospital with a diagnosis of AAV are also eligible for participation.
- Informed consent will be obtained via usual verbal and written procedures in the clinic itself. Consent will be obtained by clinical research personnel.
- None.
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes
- Non-hospitalized outpatients who are undergoing initial placement of an enteral gastrostomy (G) or jejunostomy (J) tube.
- Age ≥ 22 years.
- Current or history of illegal drug use in the past year.
- Current tobacco use.
- History of a percutaneous enteral tube.
- History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.).
Spinal Cord Stimulation Analysis of Usage Over a 15-Year Period (SASAUP)
Analysis of Spinal Cord Stimulation Usage Over a 15-Year Period
- Adults (≥ 18 years old).
- Patients at Mayo Clinic Arizona and Mayo Clinic Minnesota who participated in spinal cord stimulator trial from January 2010 to December 2019.
- Patients who subsequently underwent permanent implantation of spinal cord stimulator.
- These subjects will be contacted via e-mail or telephone to complete a standardized “yes/no” questionnaire to assess current SCS usage, effectiveness of their implant, overall satisfaction, as well as determine how many patients underwent explantation.
- Individuals under 18 years old.
- Did not participate in spinal cord stimulator trial nor undergone spinal cord stimulator implantation between January 2010 and December 2019.
AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
- Patients must be < 50 years at the time of enrollment.
- Patient must have eligibility confirmed by rapid central imaging review.
- Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size.
- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
- Patients must have a histological diagnosis of osteosarcoma.
- Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
- Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
- Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
- Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least
equivalent to MAP.
- Patients with unresectable primary tumor.
- Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central
lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
- Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.
- Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy.
Note: Once the patient has been enrolled on the study,
additional computed tomography (CT) scans are not anticipated prior to thoracic surgery.
Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
- Patients with evidence of extrapulmonary metastatic disease.
- Patients who received pulmonary surgery for lung metastasis prior to enrollment.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.
MC210301 Long Term Followup of Patients Enrolled in MC1137 (BEAUTY) (BEAUTY)
Long-term Follow Up of Patients Previously Enrolled in MC1137 (BEAUTY)
For patients still alive:
- Enrolled in BEAUTY Study (MC1137) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up.
- Able to provide written informed consent.
- Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY (Request tissue from prior biopsy of site of recurrence).
- Ability to complete questionnaires by themselves or with assistance.
For patients who have died:
- Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up.
- Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY.
- Not enrolled in BEAUTY study (MC1137).
Eligibility last updated 6/30/22. Questions regarding updates should be directed to the study team contact.
Post-Operative Mobility after Operative Fixation of Geriatric Distal Femur Fractures: Which Construct Gives Patients More Independence?
Post-Operative Mobility after Operative Fixation of Geriatric Distal Femur Fractures
- Patients ≥ 60 years old who sustain a low energy distal femur fracture (AO-OTA 33A-C) and can give informed consent will be included.
- Patients with neuromuscular pathology that precludes safe or normal ambulation, metastatic disease, major psychiatric illness, or active drug or alcohol abuse.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/22/23. Questions regarding updates should be directed to the study team contact.
(ECTx) DS1062-A-U102, Phase 1b, Multicenter, Open-label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Pembrolizumab with or without Platinum Chemotherapy in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung02) (TROPION-Lung02)
A Study to Evaluate DS-1062a Combined with Pembrolizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
- Histologically confirmed at diagnosis of NSCLC that:
- Is advanced or metastatic.
- Participants with non-squamous histology must have documented negative test
results for actionable EGFR and ALK genomic alterations. Participants with
squamous histology are required to undergo testing for EGFR and ALK genomic
alterations if they are nonsmokers or under the age of 40 years.
- Has either documented negative or unknown test results for actionable genomic
alterations in ROS1, NTRK, BRAF, RET, MET, or other actionable oncogenic driver
kinases.
- Participants with tumors that harbor KRAS mutations are eligible for this study.
- Participants with non-actionable genomic alterations in EGFR, ALK, ROS1, NTRK,
BRAF, RET, MET, or other kinases are eligible for the study.
- Documentation of radiological disease progression while on or after receiving the most
recent treatment regimen, if any, for advanced or metastatic NSCLC.
- Must meet the following prior therapy requirements for advanced or metastatic NSCLC:
- Dose escalation (all cohorts): Has received ≤2 lines of prior anticancer therapy
for locally advanced or metastatic NSCLC.
- Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with
200 mg fixed dose of pembrolizumab): Has not received PD-1/PD-L1, PD-L2, CTLA-4
directed immunotherapy and may or may not have been treated with systemic
chemotherapy for advanced or metastatic NSCLC.
- Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with
200 mg fixed dose of pembrolizumab and 4 cycles of AUC 5 carboplatin or cisplatin
75 mg/m^2): Has not been treated with systemic anticancer therapy for advanced or
metastatic NSCLC.
- Willing and able to undergo a mandatory tumor biopsy.
- Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue
is available, for measurement of TROP2 expression levels or other biomarkers.
- Has adequate bone marrow reserve and organ function at baseline within 7 days prior to
Cycle 1 Day 1.
- Is not a candidate for surgical resection or chemoradiation with curative intent.
- Experienced grade 3 or higher immune-related adverse events (AEs) with prior treatment
of anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 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).
- Received a live vaccine within 30 days prior to the first dose of study treatment.
- Active, known, or suspected autoimmune disease.
- Concomitant use of chronic systemic (IV or oral) corticosteroids or other
immunosuppressive medications, except for managing AEs.
- Prior organ transplantation, including allogeneic tissue or solid organ
transplantation.
- Has spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required
steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be
ruled out by imaging at screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary
illnesses.
- History of another primary malignancy (beyond NSCLC) except for:
- Malignancy treated with curative intent and with no known active disease for ≥3
years.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of
Stage ≤T2cN0M0 without biochemical recurrence or progression.
Methylation and Chromatin Abnormalities in Myelodysplastic Syndromes and Chronic Myelomonocytic leukemia.
Methylation and Chromatin Abnormalities in Myelodysplastic Syndromes and Chronic Myelomonocytic leukemia.
- Patients with myeloid neoplasms including MDS, MDS/MPN overlap syndromes and CMML
- Any patients not meeting the above mentioned disease criteria.
- Any patient who has declined participation in research activity.
- For quarterly samples if hemoglobin is <8 gm/dl and/or HCT < 30%
A Biorepository of Induced Pluripotent Stem Cells from Subjects with Liver Disease
A Biorepository of Induced Pluripotent Stem Cells from Subjects with Liver Disease
- Age 18 years or older.
- Able to provide written or verbal informed consent.
- Healthy volunteersor patients diagnosed with suspected, possible, probable, or definite chronic liver disease by a Mayo hepatologist or liver surgeon.
- Age 17 years and younger.
Detection of Circulating tumor cells (CTC) from Patients with Hepatocellular Carcinoma (HCC)
Detection of Circulating tumor cells (CTC) from Patients with Hepatocellular Carcinoma (HCC)
- Adult, age 18 to 100
- Patients with BLC C HCC with portal vein invasion or extrahepatic metastasis.
- Patient with significant anemia (Hemoglobin <7g/dL)
Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
- Adults: 18-100
- Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy
- Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.)
- Kidney Disease/Poor Renal Function
- Elevated creatinine levels
- Seizures
- Asthma
- Hemolytic anemia
- Claustrophobia
- BMI over 45
Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence
Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence
- Adults self-referred or referred by their physicians starting a senotherapeutic intervention.
- Any individual with senescence-associated medical conditions as defined above, refractory to current standards or care, or without known treatments.
- Any individual taking senotherapeutic agents or performing dietary restriction for any reason.
- Absolute contraindications to indicated senotherapeutic agents due to drug-drug or other interactions.
- Pregnancy or breast-feeding.
- Clinically significant dehydration, infection, renal or hepatic insufficiency.
- Excessive acute or chronic alcohol use.
- Acutely ill individuals requiring hospitalization, emergency, or urgent care.
Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial (VIP BOLT)
A Trial of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
- Bilateral Lung Transplantation (LTx) recipients.
- Mean pulmonary artery pressure < or = 35 mmHg.
- Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.
- Single lung transplant
- Multiorgan transplant.
- Donor after cardiac death (DCD).
- Re-transplant.
- Intention to use prophylactic post-operative ECMO.
- Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge
resection are not an exclusion criterion.
- Previous pleurodesis.
- Preoperative ECMO and/or mechanical ventilation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/29/23. Questions regarding updates should be directed to the study team contact.
Pediatric Neuromyelitis Optica Spectrum Disorder (NMOSD) 1 Year Observational Study
Pediatric Neuromyelitis Optica Spectrum Disorder (NMOSD) 1 Year Observational Study
- NMOSD/AQP4-IgG positive at time of enrollment, or historically positive sample tested on a reliable assay [ex. cell based assay (CBA), or fluorescence-activated cell sorting (FACS)].
- Diagnosis of NMOSD
- Male and female children
- Age between 2-17 years at time of enrollment
- Ability to give consent/assent (by patient or caregiver) as appropriate per IRB guidelines
- Ability and willingness to complete the study
- Inability to provide informed consent
- Inability to complete required forms via phone, mail or email.
Recurrent Clostridium Difficile vs Post Infectious IBS: A Prospective Study
Recurrent Clostridium Difficile vs Post Infectious IBS: A Prospective Study
Inclusion Criteria:
- Adults >18years of age
- Attending Mayo Clinic
- At least 1 prior documented episode of CDI
- Presenting with diarrhea with at least 3 bowel movements/24 hours of Bristol type 6-7, no alternative diagnosis
- Not started on antimicrobial treatment
- Written informed consent
- Prior diagnosis of Irritable Bowel Syndrome
- Fulminant CDI (hypotension or shock, ileus, or megacolon)
- Severe CDI (WBC >15,000/ul , or creatinine >1.5 mg/dL)
- Diagnosed Inflammatory Bowel Disease
- Concomitant laxative intake
TRE in Type 2 Diabetes (See Food Study 3) (SFS3)
• Overweight/obese adults with metformin-only treated type 2 diabetes
• 18-65 years old
• BMI:25-35 kg/m2
• HbA1c: 6.5-8.5%
• Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
• Owns a smartphone.
• Active or anticipated pregnancy during the study
• type 2 diabetes treated with medications other than metformin
• presence of eating disorders as noted by screening survey.
Early Naturalistic Hands-on Autism Caregiver Training (ENHAnCE) Study (ENHANCE)
Early Naturalistic Hands-on Autism Caregiver Training
- Children diagnosed with autism spectrum disorder (ASD).
- Between 2 years, 0 months to 4 years, 11 months of age.
- With less than phrased speech.
- Child must have at least one caregiver willing to participate in the study.
-
Children and parents if they do not meet the above inclusion criteria.
Global Prevalence of Hidradenitis Suppurativa - Scientific Collaboration
Hidradenitis Suppurativa Global Prevalence
- 18 years or older.
- Generally healthy adult (At the discretion of the PI).
- Visitor accompanying a current mayo clinic patient to an appointment.
- Patient and the patient’s visitor cannot be being seen in the dermatology department.
- Known diagnosis of Hidradenitis Suppurativa.
Eligibility last updated 9/13/22. Questions regarding updates should be directed to the study team contact.
Noninvasive Ultrasound Assessment of Detrusor Dysfunction (QUBV)
Ultrasound Bladder Vibrometry
Inclusion Criteria;
- Age ≥ 18 years old.
- Scheduled to undergo UDS for clinical care of one of the included diagnoses.
- Obesity (BMI > 35kg/m^2).
- Known neurologic disease impacting bladder function (e.g., spinal cord injury, multiple sclerosis, Parkinson’s, prior cerebrovascular accident).
- Previous pelvic radiation therapy.
- Previous radical pelvic surgery (such as for uterine or colorectal cancer).
- Prior bladder surgery (including prostate resection).
- Pregnant or breast-feeding women.
Eligibility last updated 11/8/22. Questions regarding updates should be directed to the study team contact.
Gene transcriptional profile of normal biceps muscle
Normal Biceps Muscle Gene Transcriptional Profile
- ≥ 18 years or age.
- Undergoing open cubital tunnel release at the level of their elbow will be selected to collect muscle biopsies of their biceps muscle.
- Previous history of peripheral nerve injury involving the musculocutaneous nerve.
- Previous history of surgery at the level of the arm (fractures around the shoulder or elbow).
- Medical history of neurological diseases.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.
Natural History of Von Willebrand Disease (VWD)
Von Willebrand Disease Natural History
- Patients with type 1 Von Willebrand Disease (VWD).
- Unable to give informed consent or assent.
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.
Hair cortisol in diagnosis of endogenous hypercortisolism.
Diagnosing Endogenous Hypercortisolism with Hair Cortisol
- ≥ 18 and ≤ 95 years old.
- Undergoing evaluation for endogenous Cushing Syndrome by various laboratory methods as a part of clinical evaluation at the Endocrine clinics.
Patients with baldness; however, 70-80% population of CS is represented by women.
- Patients exposed to exogenous glucocorticoids.
Computational Analysis of Spoken Language in Mania
Spoken Language Computational Analysis in Mania
- Ages 18-75, inclusive.
- Assigned male or female at birth.
- Provision of informed consent before any study procedures are performed.
- English speaker.
- Documented clinical diagnosis for Bipolar I Disorder.
- Currently experiencing a manic or hypomanic episode as determined by primary clinical staff.
- Age under 18 or greater than 75 years.
- Positive urine drug screen for amphetamines or cocaine.
- Expressing paranoid delusions regarding electronic surveillance corresponding to YMRS question 8 > 6.
- Documented clinical diagnosis of neurologic disorder causing dysarthria.
- Documented clinical diagnosis of developmental delay or congenital hearing impairment.
- Currently involuntarily hospitalized.
- Deemed by clinical staff to not be appropriate for voice recording.
- YRMS > 30.
- Failure to comprehend study objectives via comprehension questionnaire.'
- Individuals who have a guardian or are otherwise unable to consent for themselves.
- Current communicable disease requiring isolation.
Eligibility last updated 12/11/23. Questions regarding updates should be directed to the study team contact.