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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

3705 Study Matches

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Developing a Platform for Remote at Home Preoperative Evaluation for Obstructive Sleep Apnea

Preoperative Evaluation for Obstructive Sleep Apnea at Home

Amir Lerman
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308528-H01-RST
22-007042
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Inclusion Criteria:

  • ≥ 18 years of age
  • Patients participating in the virtual preoperative evaluation process at Mayo Clinic
  • Undergoing virtual preoperative evaluation
  • Surgery date ≥ 2 weeks from participation
  • STOPBANG score > 4.


Exclusion Criteria:

  • Patients less than age 18 years.
  • Subjects who are not able to provide consent.
  • Patients without the ability to connect to Wi-Fi to transmit home sleep study data.

Eligibility last updated 7/5/22. Questions regarding updates should be directed to the study team contact.

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Predicting Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) after Hematopoietic Stem Cell Transplantation (HSCT)

Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) Following Hematopoietic Stem Cell Transplantation

Hemang Yadav
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308529-H01-RST
22-006326
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Inclusion Criteria:

  • 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.

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Prevalence and predictors of antineuronal antibody positivity in three cohorts of epilepsy with different risks of autoimmune epilepsy

Antineuronal Antibody Positivity Prevalence and Predictors in Epilepsy With Different Risks of Autoimmune Epilepsy

Kelsey Smith
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308545-P01-RST
22-006431
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Inclusion Criteria:

Cohort A will consist of epilepsy of unknown cause (high pretest probability):

  • ≥ 18 years of age.
  • Focal epilepsy diagnosis.
  • Onset of epilepsy after age 5.
  • No known cause of epilepsy OR presence of hippocampal sclerosis on MRI and;
  • Brain MRI completed prior to enrollment.

Cohort B will consist of epilepsy of known cause (medium pretest probability):

  • Age above 18.
  • Focal epilepsy diagnosis.
  • Known cause of epilepsy including any of the following:
    • confirmed viral;
    • bacterial or parasitic CNS infection;
    • traumatic brain injury, stroke;
    • intraventricular hemorrhage;
    • hypoxic-ischemic encephalopathy;
    • neurocutaneous syndrome;
    • confirmed inborn error of metabolism;
    • confirmed genetic and chromosomal developmental encephalopathy;
    • confirmed genetic epilepsy;
    • malformation of cortical development;
    • neoplasia;
    • neurodegenerative disease.
  • Brain MRI completed prior to enrollment.

Cohort C will consist of idiopathic genetic generalized epilepsy (low pretest probability):

  • Age above 18.
  • Idiopathic generalized epilepsy (juvenile myoclonic epilepsy, juvenile absence epilepsy or generalized tonic-clonic seizures alone).
  • Brain MRI completed prior to enrollment.

Exclusion Criteria

Cohort A :

  • Contraindication for a lumbar puncture (i.e., intracranial mass, bleeding diathesis, spinal developmental anomalies, or local skin infection involving the lower back).
  • Evidence of progressive neurological illness.
  • Prior epilepsy surgery.
  • Known diagnosis of autoimmune encephalitis.
  • Prior treatment with immunosuppressive treatment for neurological symptoms.

Within Cohort A, a sub-cohort with probable autoimmune epilepsy (very high pretest probability
•Cohort A-1) will be selected with the following criteria:

  • Seizure onset in the last 1 year.
  • At least 3 out of the following 6 criteria:
  • High frequency of seizures (at least 4/month for the last 3 months);
  • Antiepileptic drug (AED) resistant (to at least 2 past and/or current AEDs);
  • Comorbid depression and/or psychosis requiring psychotropic medication;
  • History of status epilepticus;
  • Seizures with autonomic semiology defined as any of the following (on history):
    •     cardiovascular (tachycardia, bradycardia, cardiac arrhythmia);
    •     respiratory (cough, hyperventilation, apnea);
    •     gastrointestinal (epigastric sensation, nausea, vomiting);
    •     thermoregulatory, vasomotor and secretory (fever, piloerection, flushing, hypersalivation, spitting);
    •     genitourinary (urinary urge or incontinence).
  •  Fulminant onset of epilepsy characterized by any of the following:
  •      status epilepticus;
  •      ii. viral prodrome (fever, sore throat, runny nose);
  •      iii. cognitive decline noted in the first 3 months following onset of seizures;
  •      iv. new onset psychiatric symptoms (depression and/or anxiety and/or psychosis) in the first 3 months following onset of seizures.

Cohort B and C: 

  • Contraindication for a lumbar puncture (i.e. intracranial mass, bleeding diathesis, spinal developmental anomalies, or local skin infection involving the lower back).
  • Prior epilepsy surgery.
  • Known diagnosis of autoimmune encephalitis.
  • Prior treatment with immunosuppressive treatment for neurological symptoms.

Eligibility last updated 6/17/22. Questions regarding updates should be directed to the study team contact.

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Is Meeting the Spinal Cord Injury Physical Activity Guidelines Associated with Health-Related and Psychosocial Outcomes?

Spinal Cord Injury Physical Activity Guidelines in Association with Health-Related and Psychosocial Outcomes

Carmen Terzic
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308548-P01-RST
22-006458
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Inclusion Criteria:

  • All SCIMS participants following completion of their regularly scheduled Form II follow-up during the enrollment period for this module.


Exclusion Criteria:

  • SCIMS participants who do not complete their regularly scheduled Form II follow-up within the enrollment period for this module will not be included (e.g., lost to followup, declined to participate in the Form II follow-up, deceased).

Eligibility last updated 6/17/22. Questions regarding updates should be directed to the study team contact.

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Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Characterization of Chronic Kidney Disease With Renal Microvessel Imaging

Shigao Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308562-H01-RST
22-006499
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Inclusion Criteria:

  • Healthy volunteers
    or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
  • ≥ 18 years of age.


Exclusion Criteria:

  • Subjects lacking capacity to consent.
  • Vulnerable subjects such as prisoners; pregnant women; nursing mother.
  • Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
  • Patients with high-risk cardiac diseases.

Eligibility last updated 6/22/22. Questions regarding updates should be directed to the study team contact.

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Impact of POCUS and artificial intelligence-enabled electrocardiogram on detection of asymptomatic patients with aortic stenosis.

Function of Artificial Intelligence-enabled Electrocardiogram in Early Detection of Patients With Aortic Stenosis

Jae Oh
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308568-H01-RST
22-006522
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Patients with positive AI-ECG for AS within 1 year or current will be retrospectively and prospectively identified.


Exclusion Criteria:
 

  • Patients with previous valve surgery, permanent pacemaker, active infective endocarditis, or those who have already been diagnosed as AS.

Eligibility last updated 6/20/22. Questions regarding updates should be directed to the study team contact.

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A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of GDC-6599 in Patients with Chronic Cough

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Vivek Iyer
All
18 years to 80 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308578-P01-RST
22-006576
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Inclusion Criteria:


- Previous diagnosis of CRC, despite optimized treatment for asthma or COPD, or UCC for
at least 1 year.

- Chest X-ray or computed tomography (CT) scan thorax within 5 years prior to screening
visit that confirms the absence of any clinically significant abnormality contributing
to the chronic cough in the opinion of the investigator.

- Cough severity VAS score ≥ 40 at screening visit.

- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted at
screening".

- Mannitol CDR ≥ 12 coughs/100 mg determined at screening visit mannitol challenge test

- For women of childbearing potential: agreement to remain abstinent or use
contraception For men: agreement to remain abstinent or use a condom, and agreement to
refrain from donating sperm.

Inclusion Criteria for Patients with CRC with Atopic Asthma or Patients with CRC with
Non-Atopic Asthma (Part A).

- Physician diagnosis of asthma for ≥ 12 months based upon GINA STEP 2-5.

- Stable treatment with ICS therapy (GINA STEP 2) or ICS therapy and at least one
additional controller (GINA STEP 3- 5) for ≥ 3 months.

- Patients with atopic asthma (n = 20), based upon historic record of positive test for
atopy (if available), or confirmed at screening by positive fluorescence enzyme
immunoassay for specific IgE against at least one of the following five perennial
aeroallergens: animal (cat dander, dog dander, cockroach), dust mite (Dermatophagoides
farinae, Dermatophagoides pteronyssinus), and mold mix.

- Patients with non-atopic asthma (n = 20), based upon historic record of negative test
for atopy (if available), or confirmed at screening by negative ImmunoCAP test result
for all five perennial aeroallergens: animal (cat dander, dog dander, cockroach), dust
mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), and mold mix, and
relevant local allergens, and no history of symptoms suggesting atopy.

- Never or former smoker (≥ 6 months prior to screening) with < 20 pack-years or
equivalent history.

Inclusion Criteria for Patients with CRC COPD-CB or Patients with CRC COPD (Part B):

- Diagnosis of COPD GOLD I-II ± CB.

- Stable background treatment consisting of a bronchodilator medication and or stable
ICS therapy for ≥ 12 weeks prior to screening visit.

- Former smoker with ≥ 10 pack-years or equivalent history within 6 months of screening.

- Post-bronchodilator FEV1/ forced vital capacity (FVC) ratio ≤ 0.70 at screening.

- Chest X-ray or CT scan within 6 months prior to screening visit or during the
screening period (prior to randomization [Study Visit 2]), that confirms the absence
of clinically significant lung disease besides COPD.


Exclusion Criteria:


- Pregnant or breastfeeding, or intention of becoming pregnant during the study or
within 28 days after the final dose of GDC-6599.

- History of diagnosed bleeding diathesis or easy bruising or bleeding.

- Post-bronchodilator FEV1/ FVC ratio < 0.60 at screening visit (patients with CRC
asthma and UCC only: Part A).

- History of significant hepatic impairment.

- History of aspiration or recurrent pneumonia.

- Respiratory infection (including upper respiratory infection) within 8 weeks prior to
screening.

- Treatment with any strong inhibitor or inducer of CYP3A within 28 days or 5
drug-elimination half-lives, whichever is longer, prior to initiation of study drug.

- Treatment with angiotensin-converting enzyme (ACE) inhibitor within 12 weeks prior to
screening (Study Visit 1) through completion of the study.

- Treatment with opioids (including codeine), pregabalin, gabapentin, amitriptyline, or
nortriptyline for the treatment of cough within 2 weeks prior to screening (Study
Visit 1) through completion of the study.

- Treatment with cough suppressant medication within 2 weeks prior to screening (Study
Visit 1) through completion of the study.

- Known coronavirus 2019 (COVID-19) infection, persistent symptoms of known prior
COVID-19 infection, and/or known positive COVID-19 test within at least 8 weeks prior
to screening and randomization.

- Clinical laboratory value outside the reference range for the test laboratory at
screening.

- Any serious medical condition or abnormality in clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study.

- History of malignancy within 5 years prior to screening, except for appropriately
treated carcinoma in situ of the cervix or non-melanoma skin carcinoma.

Eligibility last updated 2/10/23. Questions regarding updates should be directed to the study team contact.

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Smartwatch and Physician Well-Being: Are Wearables Part of the Solution?

Smartwatches as Part of the Solution for Physician Well-Being

Colin West
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308587-P01-RST
22-006596
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Inclusion Criteria:
 

  • Physician (residents/fellows or practicing faculty physician) employed by the University of Colorado School of Medicine or Mayo Clinic with no anticipated departure within 18 months of enrollment.
  • Physicians must be employed full-time or part-time (at 60% FTE or higher) and have an Android or iOS smart phone.  


Exclusion Criteria:

  • Not in the age range.
  • Not a physician employed by the University of Colorado School of Medicine or Mayo Clinic.
  • Does not own an Android or iOS smart phone. Non-reading subjects.
  • Residents/fellows in their last final year of their respective training program.

Eligibility last updated 6/22/22. Questions regarding updates should be directed to the study team contact.

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3D Ultrasound Imaging of the Axillary Lymph Nodes

3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer

Shigao Chen
Female
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2022-308590-H01-RST
22-006606
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Inclusion Criteria:


- Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care.

- Age of 18 or older.


Exclusion Criteria:


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

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Managing Multiple Seizure Types with Wearable Devices

Development of a Practical, Minimally Invasive Seizure Gauge

Benjamin Brinkmann
All
12 years to 90 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-308608-H01-RST
22-006702
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Inclusion Criteria:

- Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g.,
NeuroPace RNS, Medtronic PC+S, Medtronic RC+S).
- Pediatric subjects 7 years of age or older.


Exclusion Criteria:

- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
- Presence of open or healing wounds near monitoring sites (infection risk).

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

 

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Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Matthew Abdel
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308626-H01-RST
22-006739
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Inclusion Criteria:
 

  • Patients ≥ 18 years or older. 
  • Patients who speak English and are willing to sign the consent form
  • Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 3 months from surgery; symptoms < 3 weeks in duration) of a total knee or total hip arthroplasty, defined as:
    • A sinus communicating with the prosthesis OR
    • Two positive cultures obtained from the prosthesis OR
    • 4 of 5 criteria:
      • Elevated ESR (> 30mm/hr) and CRP (> 10mg/L);
      • Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on;
      • leukocyte esterase strip;
      • Elevated synovial neutrophil percentage (> 80%);
      • One positive culture;
      • Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high;
      • Power field in 5 high power fields x 400).
  • OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR


Exclusion Criteria:

  • Patients with a chronic PJI, defined as:
    • Presentation of symptoms > 4 weeks in duration.
  • Revision surgery or previous two-stage reimplantation.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

 

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A Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension

Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

Elaine Wirrell
All
4 years to 55 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-308664-P01-RST
22-007953
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Inclusion Criteria:

Subject must have a documented history of Lennox-Gastaut syndrome by:

  • Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure.
  • History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz).
  • History of developmental delay.
  • Male or female subjects.
  • Subjects must be age 4-55 years at the time of consent/assent.
  • Must have been < 11 years old at the onset of LGS.
  • Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) each week during the 4-week Baseline period preceding randomization. Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. For seizures that occur in clusters: if countable, an exact seizure count should be used; if uncountable, the caregiver should estimate the number of seizures.
  • Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1.
  • If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
  • Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
  • Parents or caregivers must be able to keep accurate seizure diaries.
  • Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.
  • Subject and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
  • Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.
  • History of COVID-19 vaccination is permitted.


Exclusion Criteria:

  • Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor.
  • Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct.
  • Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline.
  • Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling.
  • Current use of felbamate with less than 18 months of continuous exposure.
  • Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.
  • Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline.
  • Status epilepticus within 12 weeks of Visit 1.
  • Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as determined by the Investigator.
  • Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2).
  • Subject has a history of any serious drug-induced hypersensitivity; e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated < 5 months year prior to enrollment. Stimulation parameters that have been stable for < 4 weeks, or battery life of unit not anticipated to extend for duration of trial.
  • Subject is pregnant, may be pregnant, lactating or planning to be pregnant.
  • Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
  • Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
  • Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are < 3 x ULN.
  • Subject with total bilirubin [TBL] > 2 x ULN (except for Gilbert's syndrome).
  • Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1).
  • History of positive antibody/antigen test for human immunodeficiency virus (HIV).
  • If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products.
  • Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study.
  • Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1).
  • Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin.
  • Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome.
  • Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG).
  • Benzodiazepine rescue administered on average more than once a week in the month before Visit 1.
  • Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

Eligibility last updated 6/7/23. Questions regarding updates should be directed to the study team contact.

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Real-World Functional Activity in Adult Spinal Deformity Surgery

Adult Spinal Deformity Surgery Real-World Functional Activity

Benjamin Elder
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308666-H01-RST
22-007211
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Inclusion Criteria:

  • Ages ≥ 18 years.
  • Diagnosis of degenerative thoracolumbar deformity.
  • Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis.


Exclusion Criteria:

  • Unable to return to Mayo Clinic for follow-up evaluation.

Eligibility last updated 8/5/22. Questions regarding updates should be directed to the study team contact.

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Identification of the optimal analgesic dose of intrathecal hydromorphone for pediatric patients undergoing posterior spine surgery for idiopathic scoliosis

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Kathryn Handlogten
All
10 years to 17 years old
Phase 4
This study is NOT accepting healthy volunteers
2022-308672-H01-RST
22-006823
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Inclusion Criteria:

  • Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.


Exclusion Criteria:

  • Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
  • Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
  • Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.

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Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Gregory Nuttall
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308674-H01-RST
22-006895
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Inclusion Criteria:

  • Patient undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.


Exclusion Criteria:

  • Are unable to grant informed consent or comply with study procedure.
  • Allergy or known sensitivity to magnesium or Renacidin.
  • Expected or high risk of bladder extravasation.
  • Ongoing atrial fibrillation prior to surgery.
  • Are undergoing emergency surgery.
  • Are pregnant.
  • Known hypermagnesemia.
  • Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
  • Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
  • Patients with renal insufficiency, glomerular filtration rate less than 30, since magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
  • Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.

Eligibility last updated 5/15/23. Questions regarding updates should be directed to the study team contact.

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Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

William Breen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308704-P01-RST
22-006990
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of glioblastoma.
  • ECOG Performance Status (PS) ≤ 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Postoperative/post-biopsy tumor plus surgical bed size 6 cm in maximum diameter.

Exclusion Criteria

  • Unable to undergo MRI scans with contrast.
  • Unable to undergo an 18F-DOPA-PET scan.
    • Example reasons for inability to complete this scan: Parkinson’s Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists);
  • NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the On-Study form.
  • Any of the following:
    • Men or women of childbearing potential who are unwilling to employ adequate contraception;
    • Nursing women;
    • Pregnant women.
  • IDH mutation identified in the tumor on surgical pathology.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Procedure/Surgery, Radiation
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Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy. (PIVOINE)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥ 14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

Robert Pignolo
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308712-P01-RST
22-007027
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Inclusion Criteria:


- Participant has completed the EOS or End of Treatment Visit of Study PVO-1A-301 or
PVO-1A-202 (PVO-1A-202 Parts C and D correspond to Study PVO-1A-204 in France) and did
not previously withdraw consent from any of the parent studies to be eligible for
Study CLIN-60120-452.

- Participant must be ≥ 14 years of age (aligned with the age of treated participants in
the ongoing parent studies PVO-1A-301 and PVO-1A-202/PVO-1A-204) and qualify as 100%
skeletally mature (if < 18 years, based on assessments carried out at parent EOS Visit;
if ≥ 18 years, automatically considered 100% skeletally mature) or have reached final
adult height based on investigator's assessment, at the time the Study CLIN- 60120-452
informed consent is signed.


Exclusion Criteria:


- History of allergy or hypersensitivity to retinoids, gelatin, lactose (note that
lactose intolerance is not exclusionary) or palovarotene, or unresponsiveness to prior
treatment with palovarotene.

- Uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine,
metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease.

- Intercurrent known or suspected non-healed fracture at any location;

- Any other medical condition/clinically significant abnormalities that would expose the
participant to undue risk or interfere with study assessments.

- Amylase or lipase > 2 × above the upper limit of normal (ULN) or with a history of
chronic pancreatitis.

- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN.

- Fasting triglycerides > 400 mg/dL with or without therapy.

- Suicidal ideation (type 4 or 5) or any suicidal behaviour at the Inclusion Visit as
defined by the Columbia-Suicide Severity Rating Scale (C-SSRS).

- Current use of vitamin A or beta carotene, multivitamins containing vitamin A or beta
carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use
of these products during palovarotene treatment.

- Exposure to synthetic oral retinoids other than palovarotene within 4 weeks of the
Inclusion Visit.

- Concurrent treatment with tetracycline or any tetracycline derivatives due to the
potential increased risk of pseudotumor cerebri.

- Use of concomitant medications that are strong inhibitors or inducers of cytochrome
P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib.

- Palovarotene is commercially available in the country where the study is being
conducted.

- Any reason that, in the opinion of the investigator, would lead to the inability of
the participant and/or family to comply with the protocol.

Eligibility last updated 7/1/22. Questions regarding updates should be directed to the study team contact.

Drug
Progressive myositis ossificans
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A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy (METRE-PL)

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With PL

A.J. Vinaya Simha
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308741-P01-RST
22-007213
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Inclusion Criteria:

  • Diagnosis of Partial Lipodystrophy.


Exclusion Criteria:

  • Previous treatment with metreleptin.

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

 

Drug, Other
Familial partial lipodystrophy, metreleptin
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Efficacy of Peripheral Nerve Blocks for Acute Episodic Migraine Treatment and Prophylaxis

Efficacy of Nerve Blocks for Episodic Migraine

Stephen Merry
All
18 years to 64 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-308744-H01-RST
22-007151
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Inclusion Criteria:


- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 headache days a month at a severity of 5/10 pain level or greater.

- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.

- History fits the definition of migraine:

- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe
intensity, aggravation by/causing avoidance of routine physical activity; and

- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels
better).


Exclusion Criteria:


- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.

- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:

- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;

- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);

- Intrauterine device (IUD);

- Total hysterectomy or tubal ligation;

- Abstinence (no sex).

- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or
corticosteroids.

- Previously received peripheral nerve blocks (PNBs).

- Currently anticoagulated.

- Currently receiving Botox for migraine prophylaxis.

- Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study.

- Currently using opiate medications for pain.

- History of drug or alcohol abuse within the prior two years.

- Have unstable medical or surgical diseases that could impair participation in this study.

- History of craniotomies, burr holes, skull fractures and/or have open skull defects.

- Patients with implanted nerve stimulators or shunts.

- Phobia of needles.

- Active skin or soft tissue infection overlying injection sites.

- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.

Eligibility last updated 7/24/23. Questions regarding updates should be directed to the study team contact.

Drug
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A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)

A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Konstantinos Leventakos
All
18 years to 130 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308746-P01-RST
22-010542
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Inclusion Criteria:

  • Written informed consent.
  • Aged 18 or above.
  • Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation.
  • Documented PD-L1 expression by PD-L1 IHC per local report.
  • Confirmed progression during treatment with a CPI-including regimen.
  • ECOG performance status of 0 or 1 at enrolment.
  • Life expectancy of ≥ 12 weeks at enrolment.
  • Adequate bone marrow, liver and kidney function.


Exclusion Criteria:

  • Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion.
  • Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation).
  • Previous treatment with an anti-TIGIT therapy.
  • Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
  • Primary or secondary resistance after treatment with 2 or more regimens including a CPI.
  • Symptomatic central nervous system (CNS) metastasis.
  • Thromboembolic event within 3 months prior to enrolment.
  • Other invasive malignancy within 2 years prior to screening.

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

 

Drug
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A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Disease (PF-ILDs)

Cassandra Braun
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308749-P01-RST
22-006681
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Inclusion Criteria:


1. Patients ≥ 18 years old at the time of signed informed consent.

2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).

4. Patients may be either:

- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks);

- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g., either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

5. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.

6. DLCO ≥ 25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.

7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.

8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g., Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.


Exclusion Criteria:


1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) < 0.7 at Visit 1.

2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.

3. Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).

4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.

5. Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).

6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period; e.g., hip replacement.
Registration on lung transplantation list would not be considered as planned major surgery.

7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in
situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.

8. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 x upper limit
of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.

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

Eligibility last updated 9/1/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Concordance and Communication about Perceived Financial Hardship in Patients with Multiple Myeloma and Their Caregivers

Perceived Financial Hardship in Patients with Multiple Myeloma and Their Caregivers

Nandita Khera
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308754-H01-RST
22-008274
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Inclusion Criteria:

  • Patients treated at Mayo Clinic with Multiple Myeloma and their caregivers.


Exclusion Criteria:
 

  • < 18 years of age. 

Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

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Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients

An Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients

Gustavo Cortes Puentes
All
14 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308755-H01-RST
22-007173
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Inclusion Criteria:

  • Age ≥ 14 years old. Subjects speaking any language will be offered participation.
  • Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient’s parents/guardian.
  • Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.
  • Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).


Exclusion Criteria:

  • Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
  • The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study):
  • Recent surgical procedures (< 3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery. The presence of previously known respiratory disorders including pulmonary embolism (< 6 months), pleural effusion, pneumothorax, hemoptysis.
  • Recent myocardial infarction (< 1 month), new cardiac arrythmia (< 3 months), recent cardiac pacemaker implantation (< 3 months).
  • Heart failure symptoms, significant shortness of breath, tachycardia, or angina
  • The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Diagnostic Test
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Spondyloarthritis Research Program: Biorepository of biosamples from patients with Spondyloarthritis

A Study Biomarkers for Diagnosis, Disease Activity, Prediction of Response to Therapy and Prognosis in Spondyloarthritis

Kerry Wright
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308757-H01-RST
22-007175
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Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Must be able to provide informed consent.
  • Physician diagnosis of axSpA, peripheral SpA or inflammatory bowel disease related arthritis.


Exclusion Criteria:

  • Individuals who do not comprehend English (i.e., participants must be able to read and sign a consent form without the assistance of an interpreter).
  • Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent).
  • Individuals regarded as belonging to a vulnerable population (e.g., prisoners).
  • Antibiotic exposure within two weeks of stool microbiome collection.
  • Patients who have a history of malignancy, exception: documented history of cured non-metastatic squamous or basal cell skin carcinoma will be allowed.

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

 

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Spondyloarthritis Research Program: Biorepository of biosamples from patients with psoriatic arthritis

Biorepository of Biosamples From Patients With Psoriatic Arthritis in the Spondyloarthritis Research Program

Elena Myasoedova
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308759-H01-RST
22-007176
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Inclusion Criteria:

  • All patients with PsA diagnosed after 2005.
    • Diagnosis defined as a clinical diagnosis by a rheumatologist.
  • Ability to consent.

A multifaceted approach will be utilized for recruitment of PsA patients for the study:

  • Recruitment letters will be sent to the PsA patients identified in the Rochester Epidemiology Project (REP) cohort.
  • PsA patients seen in the Division of Rheumatology that are not in REP will also be actively recruited.
  • New patients referred to our Division would also be eligible for recruitment.


Exclusion Criteria:

  • Individuals who do not comprehend English (i.e., participants must be able to read and sign a consent form without the assistance of an interpreter.)
  • Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent).
  • Individuals regarded as belonging to a vulnerable population (e.g., prisoners).
  • Antibiotic exposure within two weeks of stool microbiome collection.
  • Patients who have a history of malignancy, exception: documented history of cured non-metastatic squamous or basal cell skin carcinoma will be allowed.

Eligibility last updated 3/29/2023. Questions regarding updates should be directed to the study team contact.

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A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

Janani Reisenauer
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308799-P01-RST
22-007277
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Inclusion Criteria:

  • Subject is 18 years or older at the time of the procedure.
  • Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
  • Pulmonary nodule ≤ 2 cm in largest diameter.
  • Subject able to understand and adhere to study requirements and provide informed consent.


Exclusion Criteria:

  • Planned lymph node staging performed before nodule biopsy.
  • Nodule is a pure ground glass opacity.
  • Plan to biopsy multiple nodules.

Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

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The 4th Dimension: How Do Our Faces Change Over Time?

Mayo Employee Aging Facial Changes

Basel Sharaf
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308809-H01-RST
22-007357
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Inclusion Criteria:

  • ≥ 18 years of age. 


Exclusion Criteria:
 

  • < 18 years of age.

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

 

 

Age spots
Aging, Change in facial features, Complexion finding, Facial appearance finding, Integumentary system
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Pilot project for measuring RNA species in exhaled breath condensate of lung cancer patients and healthy controls

Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate

Farhad Kosari
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
2022-308824-P01-RST
22-007326
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Inclusion Criteria:

  • In the Lung Cancer group, any patient of 18 years or older with lung cancer.
  • In the control group, any 18 year or older volunteer with no history of Lung Cancer.


Exclusion Criteria:
 

  • Anyone with a history of lung disease, such as emphysema. Also, anyone with a history of cancer except Lung Cancer in the experimental group.

Eligibility last updated 7/15/22. Questions regarding updates should be directed to the study team contact.

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Understanding Rheumatoid Arthritis Pain Using Functional Neuroimaging

Using Functional Neuroimaging to Understand Rheumatoid Arthritis Pain

John Davis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308831-H01-RST
22-007555
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Inclusion Criteria:
 

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


Exclusion 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.

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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With MTAP Homozygous Deletion

Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Konstantinos Leventakos
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308833-P01-RST
22-007414
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Inclusion Criteria:


- Histologically confirmed diagnosis of a solid tumor malignancy with homozygous
deletion of the MTAP gene detected in tumor tissue or ctDNA.

- Unresectable or metastatic disease.

- Patients must have received standard therapies appropriate for their tumor type and
stage with disease progression on or after the most recent treatment.

1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease.

2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease.

- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation
at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.

- Age ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ function.


Exclusion Criteria:


- Prior treatment with a PRMT5 or MAT2A inhibitor therapy (Phase 2 only).

- Active brain metastases or carcinomatous meningitis.

- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of
study treatment.

- Major surgery within 4 weeks of first dose of study treatment.

- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or
other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption
syndrome) likely to alter absorption of study treatment or result in inability to
swallow oral medications.

- Cardiac abnormalities.

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

 

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