• Diagnosis of IPF or other progressive fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
• Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
• Cognitive impairment or inability to understand and follow instructions.
• Traditional PR completed within 3 months of study recruitment.
• Hospice or end-of-life care at the time of screening.
• Acute exacerbation at the time of screening.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

• Adult patients > 18 years.
• BMI over 30 kg/m^2.
• Participants can give consent to the procedure.
• Participants have no contraindications to LSG. (gastric ulceration).

• Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
• Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
• Patients with hiatal hernia > 3 cm.
• Patients with previous esophageal or stomach surgery.

Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.

• Participants from an existing IRB approved protocol (#18-008476, #14-004401, #712-98)

• Unable to complete study activities.
• Unable to read and speak English.

• Patient must be ≥ 18 years and ≤ 39 years of age at registration.
• Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
• Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
• Patient must have an ECOG performance status 0-3.
• Patient must have a life expectancy > 24 months.
• Patient must be able to complete questionnaires in English.
• Patient must have internet access through computer, tablet, or smartphone.
• Patient must have an email address.
• Patient must have a mobile phone able with text messaging capabilities.
• Patient must be able to accurately provide self-report data (e.g., per clinical judgment, cognitive function is intact). Patient must be able to provide informed consent.

• Patient must not have a recurrence or second primary cancer.
• Patient must not have basal cell skin carcinoma.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•PAD Patients:

• Mild claudication to minor tissue loss (Rutherford 1-5).
• Resting or exercise ankle-brachial index < 0.9 or toe brachial index < 0.6.
• Age 35 or more.

Inclusion Criteria
•Healthy Volunteers:

• Age 35-90.

Exclusion Criteria
•PAD Patients and Healthy Volunteers: 

• Evidence of active infection.
• Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disease.
• Poorly controlled diabetes (HbA1c > 8%).
• BMI < 18 or > 35.
• Recent other major surgery or illness within 30 days.
• Use of immunosuppresive medications or steroids.
• History of organ transplantation.
• Pregnancy, or plans to become pregnant, or lactating.

Exclusion Criteria - Healthy Volunteers:

• hsCRP > 2 mg/L.

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

Eligibility last updated 5/19/23. Questions regarding updates should be directed to the study team contact.

• Adolescents between ages of 13 and 18 years.
• Patients will complete the three week Pediatric Pain Rehabilitation Center program.
• POTS will be identified on the basis of accepted criteria (chronic symptoms of orthostatic intolerance, with heart rate increase of greater than 40 beats per minute or more with head up tilt, in the absence of orthostatic hypotension).
• For this study, the diagnosis will have been made on the basis of autonomic reflex screening performed at Mayo Clinic.
• No-Chronic pain. Chronic pain is identified as pain lasting more than 12 weeks; at the point of referral to the PPRC, pain is identified as causing functional impairment. 
• Patients will have the ability to assent for the participation in the research study.

• Documented disability including developmental delay, cognitive disability, blindness, deafness, paralysis, or psychosis.
• Metal implants, such as pacemakers or braces
• Women cannot be pregnant or breastfeeding.
• Patients will be excluded if they do not complete the three week PPRC program.

• Adolescents between ages of 13 and 18 years.
• Patients will complete the three week Pediatric Pain Rehabilitation Center program.
• POTS will be identified on the basis of accepted criteria (chronic symptoms of orthostatic intolerance, with heart rate increase of greater than 40 beats per minute or more with head up tilt, in the absence of orthostatic hypotension). For this study, the diagnosis will have been made on the basis of autonomic reflex screening performed at Mayo Clinic.
• Chronic pain is identified as pain lasting more than 12 weeks; at the point of referral to the PPRC, pain is identified as causing functional impairment. 
• Patients will have the ability to assent for the participation in the research study.

• Documented disability including developmental delay, cognitive disability, blindness, deafness, paralysis, or psychosis.
• Metal implants, such as pacemakers or braces
• Women cannot be pregnant or breastfeeding.
• Patients will be excluded if they do not complete the three week PPRC program.

• Adolescents between ages of 13 and 18 years.
• Patients will complete the three week Pediatric Pain Rehabilitation center Program
• No POTS diagnosis.
• Chronic pain is identified as pain lasting more than 12 weeks at the point of referral to the PPRC; pain is identified as causing functional impairment.
• Patients will have the ability to assent for the participation in the research study.

• Documented disability including developmental delay, cognitive disability, blindness, deafness, paralysis, or psychosis.
• Metal implants, such as pacemakers or braces.
• Women cannot be pregnant or breastfeeding.
• Patients will be excluded if they do not complete the three week pediatric Pain Rehabilitation Center Program.

• Adolescents between ages of 13 and 18 years.
• Patients will have the ability to assent for the participation in the research study.

• Documented disability including developmental delay, cognitive disability, blindness, deafness, paralysis, or psychosis.
• Metal implants, such as pacemakers or braces.
• Women cannot be pregnant or breastfeeding.
• Any active acute or chronic medical condition.

• Be a parent or legal guardian of a recruited participant for this study.
• Be able to provide informed consent to participate.

• Documented disability including developmental delay, cognitive disability, blindness, deafness, paralysis, or psychosis.

• Employed by Mayo Clinic.
• ≥ 18 years old.
• Medical condition that affects work ability.

• Less than 18 years old.

Inclusion Criteria - CRSwNP:

• Age 18 years and older.
• Both males and females.
• Meet clinical definition of CRS which is 12 weeks with at least 2 of the major criteria for diagnosis within the past 24 months (nasal discharge, nasal obstruction, facial congestion, facial pain-pressure-fullness or decrease in sense of smell).
• Presence of nasal polyps as evidenced by a CT scan or rhinoscopy.

 Inclusion Criteria
•wsf AERD aspirin desensitization

• Age 18 years and older.
• Both males and females.
• Be Aspirin sensitive (AERD)
• AERD
  •Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance and scheduled to undergo an aspirin challenge and desensitization in the allergic diseases clinical laboratory.

Inclusion Criteria - AERD non-Aspirin desensitization:

• Age 18 years and older.
• Both males and females.
• Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance.
• Contraindication to Aspirin therapy or by patient choice.

Exclusion Criteria
•All Groups:

• Cystic fibrosis.
• Known pregnancy at the time of appointment.
• Cigarette smoking in the last 6 months.
• Common Variable Immunodeficiency Disease.
• EGPA or small vessel vasculitis.
• Primary ciliary dyskinesia.
• Primary immune deficiency disorder.
• Oral corticosteroids in the past 2 weeks before visit.
• Intramuscular corticosteroids in the past 6 weeks before visit.
• Current cancer treatment with immunotherapy and chemotherapy.
• Treatment with biologics at the time of enrollment.
• Zileuton.

Eligibility last updated 12/20/21. Questions regarding updates should be directed to the study team contact.

• All patients 18 of age or greater.
• VS on final pathology report.
• Surgical intervention (RS, MF, TL, other).
• Primary and revision cases included, including prior radiation.

Exclusion Criteria;

• History of liver disease or abnormal liver function tests.
• Diabetic patients with specific contraindication to omega-3 supplementation.
• History of bleeding disorder, or recommended use of anticoagulation (not including anti-platelets or NSAIDs) during the treatment period.
• Age less than 18 years.
• Neurofibromatosis 1 or 2, or schwanomatosis disorders.
• Non-VS pathology.
• Patients already taking fish oil/omega-3 supplementation.

• Age 21-65.
• BMI ≥ 30 and ≤ 40 kg/m² .
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
• History of failure with non-surgical weight-loss methods.
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling. 
• Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow- up visits.
• Ability to give informed consent.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. 

• History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
• Prior gastrointestinal surgery with sequelae; i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions.  
• Prior open or laparoscopic bariatric surgery.  
• Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery. 
• Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease.  
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 
• Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.  
• A gastric mass or gastric polyps > 1 cm in size.  
• A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.  
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.  
• Achalasia or any other severe esophageal motility disorder.
• Severe coagulopathy. 
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ 9. 
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
• Chronic abdominal pain.
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation. 
• Hepatic insufficiency or cirrhosis.
• Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.  
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
• Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.  
• Patients receiving daily prescribed treatment with high dose aspirin (> 80 mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.  
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
• Patients who are pregnant or breast-feeding.  
• Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. 
• Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
• Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.  
• Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia or cancer.  
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.  
• Specific diagnosed genetic disorder such as Prader Willi syndrome. 
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 
• Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism. 
• If deemed medically inappropriate or ineligible by investigator. 

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

• Obese men and women ≥ 20 and ≤ 45 years of age. 

• Diabetes or fasting plasma glucose > 126 mg/dL.
• Anemia (female subjects hemoglobin of < 11 g/dl and male subjects hemoglobin < 12 g/dl).
• Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment).
• Renal failure (serum creatinine > 1.5mg/dl).
• Chronic active liver disease (AST > 144IU/L or ALT > 165IU/L).
• Oral warfarin group medications or history of blood clotting disorders.
• Smoking.
• Pregnancy or breastfeeding.
• Alcohol consumption greater than 2 glasses/day or other substance abuse.
• Untreated or uncontrolled hypothyroidism.
• Debilitating chronic disease (at the discretion of the investigators).

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

Eligibility last updated 11/28/22. Questions regarding updates should be directed to the study team contact.

PRE-REGISTRATION:

• Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e., carcinoid) as assessed by local pathology.
• The pathology report must state ONE of the following:
  • Well- or moderately-differentiated neuroendocrine tumor;
  • Low- or intermediate-grade neuroendocrine tumor.
• Carcinoid tumor (including typical or atypical carcinoid tumors): 
  • Documentation of histology from a primary or metastatic site is allowed.
• Functional (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) or nonfunctional tumors are allowed.
• Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e., large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e., adenocarcinoid tumor) are not eligible.
• Recurrent or locally-advanced/unresectable or metastatic disease.
• Neuroendocrine tumor of bronchial (i.e., lung) primary site.
• Lesions must have shown radiological evidence of disease progression in the 12 months prior to pre-registration.
• Tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to pre-registration; however, documentation of SSTR positivity in the 6 months prior to pre-registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions.
• Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy should not be considered measurable unless the lesion has clearly progressed since the procedure.
• Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 1 cm with CT or MRI (or ≥ 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.

REGISTRATION:

• Confirmation of SSTR positivity by Alliance Imaging Core Lab (ICL) at Imaging and Radiation Oncology Core (IROC) Ohio central radiographic review.
• Patients with treatment-naive or previously-treated disease are allowed. Patients with previously-treated disease must have demonstrated radiographic disease progression on the prior therapy.
• No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. < lutetium Lu 177 dotatate).
• No prior treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g., deforolimus, everolimus, sirolimus, temsirolimus, etc.).
• Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective radioembolization) or ablative therapies (i.e., cryoablation, radiofrequency ablation, etc.) is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site. Prior liver-directed or other ablative treatment must be completed at least 28 days prior to registration.
• Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to registration.
• Radiation therapy (conventional fractionated or stereotactic ablative) to the lung and/or mediastinum must be completed at least 28 days prior to registration.
• Prior treatment with systemic anticancer therapy must be completed at least 28 days prior to registration (except for somatostatin analogs in patients with functional tumors). Continuation of treatment with somatostatin analogs while on protocol therapy is allowed provided that the patient:
  • Has functional tumors (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome);
  • Has been on a stable dose of somatostatin analog therapy for at least three months;
  • Has previously demonstrated radiographic disease progression while on somatostatin analog therapy.
• Patients must have completed any major surgery at least 28 days prior to registration. Complete wound healing from major surgery should occur prior to registration.
• Patients should have improvement of any toxic effects of prior therapy (except alopecia, fatigue, and other non-reversible toxic effects such as neuropathy from cisplatin) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1 or less.
• Not pregnant and not nursing, because this study involves:
  • An investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown;
  • An agent that has known genotoxic, mutagenic, and teratogenic effects.
  • Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Hemoglobin ≥ 8.0 g/dL.
• Platelet count ≥ 75,000/mm^3.
• Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
• Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance ≥ 40 mL/min.
• Calculated by the Cockcroft-Gault equation -ION:
• Total bilirubin ≤ 2.0 x ULN.
• In patients with Gilbert's syndrome, if total bilirubin is > 2.0 x ULN, then direct bilirubin must be =< 2.0 x ULN.
• Albumin ≥ 2.8 g/dL.
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN.
• No known central nervous system metastases unless adequately treated, stable, and off steroid support for at least 14 days prior to registration.
• No other currently active malignancy that requires therapy or is expected to require therapy during the study (excluding non-melanoma skin cancers or in situ carcinomas, such as breast or cervical).
• No uncontrolled diabetes mellitus, defined as fasting glucose > 200 mg/dL, despite optimal medical therapy.
• No known uncontrolled hypercholesterolemia (defined as fasting cholesterol > 300 mg/dL OR > 7.75 mmol/L) or hypertriglyceridemia (defined as fasting triglycerides > 2.5 x ULN), despite optimal medical therapy -
• No known active hepatitis B (defined as hepatitis B surface antigen [HbsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) Patients with human immunodeficiency virus (HIV) positivity are allowed if CD4 count > 500 cells/uL.
• No known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to registration.
• No receipt of live attenuated vaccines in the 7 days prior to registration.
• No known liver cirrhosis.
• No known prior drug-induced pneumonitis that was symptomatic or required treatment
• No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent.
• No known hypersensitivity to everolimus or other rapamycin analogs (e.g., sirolimus, temsirolimus, etc.).
• Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient:
  • has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome);
  • has been on a stable dose of somatostatin analog therapy for at least three months;
  • has previously demonstrated radiographic disease progression while on somatostatin analog therapy. For subjects receiving lutetium Lu 177 dotatate, there should be a minimum of 14 days between long-acting somatostatin analogue and lutetium Lu 177 dotatate dosing. Short-acting somatostatin analogs should not be administered within 24 hours of lutetium Lu 177 dotatate dosing. Following lutetium Lu 177 dotatate dosing, long-acting somatostatin analogs may be administered between 4 and 24 hours after each dose.
• Chronic concomitant treatment with strong inhibitors or inducers of CYP3A4 is not allowed on this study. Patients on strong inhibitors or inducers of CYP3A4 must discontinue the drug(s) 7 days prior to registration.
• Chronic concomitant treatment with strong inhibitors or inducers of P-glycoprotein (PgP) is not allowed on this study. Patients on strong inhibitors or inducers of PgP must discontinue the drug(s) 7 days prior to registration.

RE-REGISTRATION:

• Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review.
• Not pregnant and not nursing.
• Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to re-registration is required.
• ECOG performance status 0-2.
• Hemoglobin ≥ 8.0 g/dL.
• Platelet count ≥ 75,000/mm^3.
• Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
• Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance ≥ 40 mL/min.
• Calculated by the Cockcroft-Gault equation.
• Total bilirubin ≤ 2.0 x ULN.
• In patients with Gilbert's syndrome, if total bilirubin is > 2.0 x ULN, then direct bilirubin must be ≤ 2.0 x ULN.
• Albumin ≥ 2.8 g/dL.
• AST/ALT ≤ 3.0 x ULN.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

• Adult (age 18 or greater) patients who consent for enrollment in the study.
• Have undergone allogeneic HSCT within 100 days or autologous HSCT within 30 days.

Exclusin Criteria: 

• Subject transferred from another institution having already been admitted there for > 24h. This proposal seeks to create a biorepository whose purpose will be to determine mechanism of ARF/ARDS development based on initial hospital course. If a substantial part of a patient’s hospital course preceeds enrollment (and is affected by care received at another institution), we may not get meaningful insights into the ARDS mechanism by enrolling them well into the disease processes that are involved in the pathogenesis of ARDS.
• ARDS at the time of hospital admission. Since this study is looking at the mechanisms of ARDS development, we would seek to enroll patients before ARDS develops. 
• Patient’s goals of care are such that ICU transfer (and specifically use of noninvasive or mechanical ventilation) would not be considered. As such, these patients would not be able to develop the outcome of interest (ARDS).
• Admitted for:
  1. Admission only for chemotherapy administration.
  2. Control of symptoms related to diarrhea, vomiting, dehydration due to inability to swallow, dysphagia, pain or mucositis. 

Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.

• Demographic characteristics: ≥ 18 and ≤ 65 years of age.
• Required laboratory results: negative pregnancy test for those with female sex assigned at birth (contraception will not be required to participate in the study).
• Health status: Schizophrenia spectrum disorder (as defined by the DSM-5; Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia, Schizoaffective Disorder, Catatonia, Other Specified Schizophrenia Spectrum Disorder, Unspecified Schizophrenia and Other Psychotic Disorder; but NOT Substance/Medication-Induced Psychotic Disorder or Psychotic Disorder Due to Another Medical Condition) for case group; control group can have any non-schizophrenia spectrum psychiatric illness with exceptions listed below  
• Ability to understand study procedures and to comply with them for the entire length of the study.
• Has an established mental health provider (e.g. ,integrated behavioral health, Mayo W11 psychiatric longitudinal clinic) or a follow up appointment with a new mental health provider within 2 weeks of study appointment.

• Demographic characteristics: < 18 or  ≥ 65 years of age.
• This exclusion criterion is implemented primarily to keep research team and patient safe. It is common for patients with psychosis to be agitated and sometimes violent in acute settings. It is also common for hostility/violence to be completely resolved with adequate treatment. Hence, a patient with recent violence while unmedicated, can have very low risk of violence once adequately treated. Risk of violence will be assessed on case-by-case basis for this study, taking into account legal history, documented history of hostility/violence in medical records, response to medications, medication non-compliance. Clinical judgment will be used to identify and exclude patients who pose significant risk of violence.
• Any active movement disorder that would interfere with quality TMS-EEG.
• Any confirmed or suspected history of a seizure.
• Any major neurocognitive disorder.
• Current diagnosis of Bipolar Disorder with psychotic features or Major Depressive Disorder with psychotic features.
• Current diagnosis of Autism Spectrum Disorder.
• No follow up appointments with a primary care physician or mental health provider.
• Positive pregnancy test
• Positive or presumptive positive urine drug screen test for alcohol or any illicit substance (with the exception of cannabis) at time of recruitment.
• Those with female sex assigned at birth with negative pregnancy test actively trying to become pregnant. Women who are lactating will be included, as long as the infant/toddler can be away from mother for the duration of the study (per mother’s judgement).
• Use of benzodiazepines; any antiepileptic drugs (including gabapentin, valproate, topiramate, carbamazepine, lamotrigine, etc.), opioids, and opioid antagonists.
• TMS or electroconvulsive treatment within the past 12 months, and any past significant adverse events with TMS exposure.
• Any past neuroanatomic findings of gross structural abnormalities; or such findings detected on the MRI. Gross structural abnormalities of the brain include aneurysms, tumors, encephalomalacia and other anatomic sequalae of trauma, infarcts, etc. Of note, in routine clinical practice significant anatomic abnormalities are rarely discovered in patients undergoing workup for psychosis.
• Any active substance use disorder, apart from cannabis and nicotine use disorder.
• Claustrophobia and inability to tolerate MRI (including MRI non-compatible implants, and movement disorders that would interfere with obtaining a quality MRI image).
• Inability or unwillingness of individual to give written informed consent.
• Current involuntary hospitalization as evidenced by active 72h hold; any type of ongoing commitment process (including provisional discharge, stay of commitment, awaiting commitment hearing, etc.).
• Insufficient knowledge of English.
• Any metal, electronic, or other implant that is incompatible with TMS or MRI technology.

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

Eligibility last updated 12/12/23. Questions regarding updates should be directed to the study team contact. 

• Adult (≥ 18 years of age) patients with incident RA defined by the 1987 ACR classification criteria.

• < 18 years old. 

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

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

• Adult partipicipants, ≥ 18 years of age.
• Participants from the partnering African-American (AA) churches.

• Individuals less than 18 years of age.

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.

• Age 18 or older.
• Diagnosis of keratoconus.
• Available baseline corneal topography and pachymetry.
• Amsler-Krumeich keratoconus classification of stage 1 or higher.

• No prior corneal transplantation or INTACTS.
• No prior use of hybrid, corneal or scleral gas permeable lenses.
• Presence of corneal scarring.

Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

• Inpatients or outpatients.
• Voluntary clinical patient with the capacity to assent (or consent if 18) to treatment and a parent or legal  guardian with the capacity to consent (if younger than 18).
• Biological female or male (nonbinary or other gender identities are not exclusionary).
• 12-18 years of age.
• Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age; The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age.
• In a current episode of MDD with duration of at least 4 weeks but less than 3 years.
• Depressive symptom severity as demonstrated by CDRS-R total composite score of forty or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R.
• A minimum score of 1 (“wish to be dead”) on the C-SSRS severity of ideation subscale.
• Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more.
• Eligible for transcranial magnetic stimulation (TMS) based on safety criteria.
• On a medically acceptable form of birth control during the 10 day acute treatment course if female and of child bearing potential.
• Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form criteria for relevant statistical considerations.

• Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
• Lifetime diagnosis of a psychotic disorder confirmed by a research screening interview (including schizophrenia, major depressive disorder with psychotic features, and bipolar disorder with psychotic features).
• Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).
• Positive urine drug screen at baseline.
• Patients with a history of epilepsy or unexplained seizures.
• Any family history of epilepsy.
• Patients medicated with drugs lowering the seizure threshold (examples: neuroleptic agents and tricyclic antidepressants).
• History of any treatment with electroconvulsive therapy or TMS.
• Use of any investigational drug within 4 weeks of baseline.
• Prior brain surgery.
• Risk for increased intracranial pressure such as a brain tumor.
• Life-time history of head trauma with loss of consciousness for greater than 5 minutes duration.
• Any true positive findings on the TMS safety screening form (TASS).
• Pregnant or nursing patients.
• Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head within. 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).
• Patients with any implanted stimulators or implants controlled by physiologic signals, including VNS, SCS, PNS, defibrillators and pacemakers.
• Patients with neurological conditions that include a history of seizures, cerebrovascular disease, cerebral aneurysm, dementia, movement disorders, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the CNS.
• Patients with a history of increased intracranial pressure, history of severe headaches within the previous 1 year, or severe head trauma.
• Implanted medication pumps and cardiac pacemakers.
• Patients suffering from vascular, traumatic, tumoral, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication.
• Patients with an unstable medical illness (other than depression).
• Inability to adhere to the protocol.

Eligibility last updated 1/20/22. Questions regarding updates should be directed to the study team contact.

Inclusoin Criteria: 

• Documentation of the participant’s informed consent to study procedures and for the use of PHI (HIPAA Authorization, if applicable):
  • NOTE: Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant’s legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc.
• Previously consented to participate in A3-45 screening.
• Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
• If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
• As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.

• Current treatment with an FDA approved medication for Alzheimer’s disease, including prior or current treatment with a prohibited medication as described in section 6.2.1.
• Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five halflives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm.
• NOTE: Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
• Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).

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

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

• ≥ 75+ years
• Part of National Patient-Centered Clinical Research Network (PCORnet) and the Veterans Affairs (VA) system.
• Enrolled in the PREVENTABLE trial.

• < 75 years of age. 

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

Eligibility last updated 5/25/23. Questions regarding updates should be directed to the study team contact.

• Healthy, pregnant women 26 – 36 weeks gestation with a singleton pregnancy and accurate dating (last menstrual period confirmed by 1st or 2nd trimester ultrasound).
• Currently receiving routine prenatal care will be recruited.

Any medical/obstetrical contra-indication to exercise during pregnancy per ACOG guidelines, including:

• • • • •  
• Hemodynamically significant heart disease.
• Restrictive lung disease.
• Incompetent cervix/cerclage.
• Increased risk for premature labor .

• Between the ages of 18-50 years old.
• Are of moderate to high fitness level and participate in regular physical activity.
• Must have a body mass index (BMI) less than 31 kg/m^2.
• Must be able to provide clear informed written consent.

• History of chronic respiratory, cardiovascular, metabolic disease or neural/cognitive disorders.
• Anemia (< 12 g/dl for males, < 11 g/dl for females).
• Migraines.
• Active smoker (smoke within the past 6 years), or have more than 5 pack-years of smoking history
• Females who are pregnant or trying to become pregnant.

Task 1 Specific:

• History of pneumothorax, functionally limiting barotraumas or any inability to equalize tympanic pressure (e.g., during diving, swimming or flying).
• Current dental abscesses or jaw pain consistent with severe dental caries.
• Prior allergies or serious side effects from vasoconstrictors such as Afrin™ (oxymetazoline hydrochloride) utilized for sinus decongestion.
• Hyperbaric exposure within the last 24 hours (for chamber visits).

• Adult (≥ 18 years of age) traumatic brachial plexus injury (BPI) patients who underwent spinal accessory nerve or intercostal nerves transfer to musculocutaneous nerve or branch to biceps from Jan 1 2010 to Dec 31 2020.
• Once consented, they will be given an appointment to return to the Mayo Clinic Brachial Plexus clinic for a physical follow-up to undergo a standard post nerve reconstruction evaluation.  For patients who consented but are not able to travel to Mayo Clinic for a physical review, a virtual consult will be scheduled. 

• Patients less than 18 years old and those with brachial plexus palsy resulting from birth injury, compressive neuropathy, resection of tumors, cervical spine surgery, radiation therapy, inflammatory or auto-immune conditions will be excluded.

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

Eligibility last updated 1/11/23. Questions regarding updates should be directed to the study team contact.

• Adult males and females, ages 40 to 85 years.
• Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years until discontinuation of treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit.  Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
• All skin phototypes ≥ grade I of Fitzpatrick’s classification.
• Mild-to-moderate global face wrinkles and mild-to-moderate global fine lines based on a modified Griffiths’ 10-point scale.
• Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
• Volunteer willingness to discontinue any other anti-aging topical or parenteral treatments for the duration of the study.
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related treatment.
• Can provide written informed consent to being photographed for purposes of treatment for medical, scientific purposes.

• Pregnant or nursing, or planning on becoming pregnant during the study period.
• Subjects who have had an antiaging or esthetic treatment prior to the study: Botox or Botox‐like products, peelings, plastic surgery, resurfacing with Laser, IPL, threats, radiofrequency treatments, hyaluronic acid treatment, Plasma‐Rich Platelets treatment, or any other specific treatments prone to change the skin aspect during the last 6 months.
• Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies, collagen diseases, or skin cancer involving the treated sites within the past 6 months.
• Cutaneous marks on the experimental area which could interfere with the assessment of skin reactions (pigmentation problems, scar elements, over‐developed pilosity, ephelides, and nevi in too great quantity, sunburn, beauty spots, freckles, etc.).
• Participants with asymmetric photodamage on dorsal hands due to environmental exposures (i.e., golfing) and/or other skin lesions including burns or scars resulting in significant skin surface variability between dorsal hands.
• Eczematous reaction still visible, scar, or pigmentary sequelae of previous tests on the experimental area.
• Allergy to colophony or nickel.
• Allergy or reactivity to drugs, food or cosmetic products previously observed, including perfumes or cologne products.
• Skin hyper‐reactivity.
• Forecast of intensive sun, tanning bed use or UV phototherapy during the test period.
• Treatment with Vitamin A acid or its derivatives within 3 months before the beginning of the study.
• Treatment with topical corticoids on the experimental area within 16 days before the study.

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