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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.

3159 Study Matches

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Patient Derived Preclinical Models

Patient Derived Preclinical Models

Aaron Mansfield
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305691-H01-RST
21-008831
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Inclusion Criteria:

  • 18 years of age and older.
  • Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
  • Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
  • Biopsy must not be considered to be more than minimal risk to the patient.
  • Have a contraindication to percutaneous biopsy including:
    • Significant coagulopathy that cannot be adequately corrected;
    • Severely compromised cardiopulmonary function or hemodynamic instability;
    • Lack of a safe pathway to the lesion per the interventional radiologist;
    • Inability of the patient to cooperate with, or to be positioned for, the procedure.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

 

 

Procedure/Surgery
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Mayo Clinic — Rochester, MN

Immune Profiling in Kidney Transplant Recipients and Living Kidney Donors

Immune Profiling of Kidney Transplant Recipients and Living Kidney Donors

Mark Stegall
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305694-H01-RST
21-008777
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Inclusion Criteria:

  • Individuals ≥ 18 years of age.
  • Adult kidney transplant recipients awaiting transplant, kidney transplant recipients and living kidney donors.


Exclusion Criteria:

  • Subjects under 18 years of age.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

 

 

 

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Undiagnosed Tumor/Undifferentiated Mass Registry (Undiagnosed Tumor/Undifferentiated Mass Registry)

Undiagnosed Tumor/Undifferentiated Mass Registry

Elizabeth Gilman
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305704-P01-RST
21-008859
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Inclusion Criteria:
  

  • Patient presenting to a General Internal Medicine Service.
  • Patient in one of the 3 Mayo Clinic Campuses (Rochester, Arizona, Florida).
  • Patient with an undiagnosed mass: New or enlarging lymph nodes clinically or on imaging:
    • New mass on imaging of soft tissues, bone, spleen, adrenal gland, retroperitoneum, or intraabdominal location without clear organ association .
  • Patient has understood and signed the informed consent to participate in the registry.
  • Patient has the ability to complete all aspects of registry enrollment.
  • Aged 18 and older.

 


Exclusion Criteria:
   

  • Mass involving the breast, brain, kidney, lung, ovary/adnexa, liver, pancreas, sinus, throat, or thyroid gland will be addressed by the respective specialty areas.  
  • Patients with a known history of any condition or factor judged by the investigator to preclude participation in the registry or which might hinder adherence.
  • Lacking the capacity to consent.
  • Prisoners or institutionalized individuals.
  • Pregnant women.

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

 

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The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population (Pathfinder 2)

PATHFINDER 2: A Multi-Cancer Early Detection Study

Karthik Giridhar
All
50 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305712-P01-RST
21-009209
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Inclusion Criteria:


1. Participants must be at least 50 years of age, inclusive, at the time of signing the
Informed Consent Form (ICF).

2. Participants must be capable of giving signed and legally effective informed consent


Exclusion Criteria:


1. Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer
(e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the
basis of a suspicious imaging abnormality).

2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within
the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior
to expected enrollment date and never treated.

- Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous
cell carcinoma of the skin are not excluded.

3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

- Definitive treatment for invasive solid tumor or hematologic malignancy within
the 3 years prior to expected enrollment date. Adjuvant hormone therapy for
cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.

4. Individuals who will not be able to comply with the protocol procedures.

5. Individuals who are not currently registered patients at a participating center.

6. Previous or current participation in another GRAIL-sponsored study. "Participation" is
defined as having signed consent and provided a blood sample.

7. Previous or current employees or contractors of GRAIL.

8. Current pregnancy (by self-report of pregnancy status)

Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test, Device
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Clinical Utility of Eosinophil-Derived Neurotoxin (EDN) in Asthma Diagnosis and Evaluation (EDN)

Eosinophil/Asthma Study

Melissa Snyder
All
1 years and over
This study is NOT accepting healthy volunteers
2021-305715-H01-RST
21-008894
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Inclusion Criteria
•Study Arm 1 Preschool Children < 6 years old 
Asthma Group (N=200) :

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year;
    • Even distribution of socio-demographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Actively sick with covid or flu.

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200)
 :

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls (N=200)
 

  • Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Diagnosis of asthma or any known upper/lower respiratory disease.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 2 Children 6-17 years of age 
Asthma Group (N=200) :

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls  (N=200)
 :

  • Diagnosis of allergy. 
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:
 

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200)
 :

  •  Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:
 

  • Diagnosis of asthma or recurrent wheezing.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 3  Adults > 18 years old
Asthma Group (N=200)
 :

  • Diagnosis of asthma.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:
 

  • Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200)
 :

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200)
 :

  •  Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteriao: 

  • Diagnosis of asthma.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

 

 

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A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) (TPN-101)

A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD

Bradley Boeve
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305733-P01-RST
21-009164
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Inclusion Criteria:


- Have documentation of a clinical genetic test demonstrating the presence of a
confirmed repeat expansion in the C9orf72 gene from a CLIA certified laboratory

- Score ≥ 18 on the Mini-Mental State Exam (MMSE) at Screening

- Have a reliable caregiver to accompany the patient to all study visits.

- For patients with ALS (with or without FTD):

- Diagnosis of ALS (probable, possible, laboratory-supported probable or definite)
according to the World Federation of Neurology revised E1 Escorial criteria

- Onset of weakness within 3 years prior to Screening

- Slow vital capacity (SVC) ≥ 60% of predicted normal adjusted for sex, age, and
height (from the sitting position)

- ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at Screening

- For patients with FTD:

- A gradual, progressive decline in behavior, language, or motor function
consistent with C9ORF72 hexanucleotide expansion-related syndrome such as
behavioral variant FTD, primary progressive vaphasia, or amnestic syndrome

- CDR Dementia Staging Instrument plus National Alzheimer's Coordinating Center
Behavior and Language Domains (CDR plus NACC FTLD) global score of 0.5-2.0 at
Screening


Exclusion Criteria:


- Presence of other significant neurological or psychiatric disorders

- History of significant brain abnormality, including, but not limited to, prior
hemorrhage or infarct, cerebral contusion, encephalomalacia, aneurysm, vascular
malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess
or brain tumor such as meningioma); symptoms or signs of elevated intracranial
pressure, e.g., symptoms or history of head injury or abnormal funduscopic exam. If
there is history or evidence on neurologic exam suggesting possible subdural hematoma
(SDH), patients should be fully evaluated, including magnetic resonance imaging (MRI)
if indicated, to exclude significant, new SDH

Drug
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Enhancing the Natriuretic Peptide System in HFpEF: A Randomized Double-Blind Placebo-Controlled Triple Crossover Study

Enhancing the Natriuretic Peptide System in HFpEF

Paul McKie
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305738-H01-RST
21-008978
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Inclusion Criteria:

  • Group 1: HFpEF-CKD-will consist of 30 subjects with:
    • Ejection fraction of greater than 55%; and
    • Evidence of increased LV filling pressures, including at least 2 of the following:
    • average septal–lateral E/e’ ratio > 15;
    • tricuspid regurgitation (TR) peak velocity > 2:8 m/s;
    • Left atrial volume index >34mL/m^2 assessed by echocardiography; and
    • Previous diagnosis of HF with New York Heart Association (NYHA) functional class II-III symptoms on chronic loop diuretic therapy; and
    • CKD defined as glomerular filtration rate (eGFR) of 15-60 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation. Subject needs to be on stable dose of chronic loop diuretic for at least 4 weeks prior to study and maintained on the same dose for the duration of the study. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI > 35 (because endogenous natriuretic peptide levels are low in obese subjects).
  • Group 2: HFpEF-EI-will consist of 30 subjects with:
    • Ejection fraction of greater than 55%; and
    • Previous invasive determination of normal pulmonary capillary wedge pressure (< 15 mmHg) at rest and ≥ 25 mmHg during exercise12; and
    • New York Heart Association (NYHA) functional class II-III symptoms but not on chronic loop diuretic therapy; and
    • Glomerular filtration rate (eGFR) of > 60 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI>35 (because endogenous natriuretic peptide levels are low in obese subjects).


Exclusion Criteria:

  • Age < 18 years.
  • Body mass index > 35.
  • Blood pressure < 100/60 or > 180/100 mmHg.
  • Diabetes.
  • Myocardial infarction within 6 months of screening.
  • Unstable angina within 6 months of screening, or any evidence of myocardial ischemia.
  • Significant valvular heart diseases.
  • Hypertrophic, restrictive or obstructive cardiomyopathy.
  • Constrictive pericarditis.
  • Primary pulmonary hypertension.
  • Biopsy proven active myocarditis.
  • Severe congenital heart diseases.
  • Cardiac amyloidosis.
  • Fabry disease.
  • Sarcoidosis.
  • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.
  • Second or third degree heart block without a permanent cardiac pacemaker.
  • Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
  • Hemoglobin < 9 g/dl.
  • ALT > 2 times the upper limit of normal; serum sodium of  < 135 mEq/dL or > 150 mEq/dL.
  • Serum potassium of < 3.5 mEq/dL or > 5.7 mEq/dL.
  • Bother acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data.
  • Received an investigational drug within 1 month prior to dosing.
  • Patients with an allergy to iodine; female subject who is pregnant or breastfeeding.
  • In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.

Eligibility last updated 3/16/22. Questions regarding updates should be directed to the study team contact.

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A Phase 2, Two-part, Placebo-controlled, Parallel-group, Double-blind Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Participants 5 years of Age and Older (IPN60130)

A Study Assessing the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for FOP

Robert Pignolo
All
5 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305740-P01-RST
21-008980
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Key

Inclusion Criteria:


- Written, signed, and dated informed subject/parent consent; and for subjects who are
minors, age-appropriate assent (performed according to local regulations).

- Participants must be clinically diagnosed with FOP, with the R206H ACVR1 mutation or
other FOP variants associated with progressive HO.

- Participants must have disease progression in the preceding year of the screening
visit.

- Participants who have participated in a prior clinical study using another
investigational product for the treatment of FOP may be enrolled after a washout of at
least 5 half-lives of the other investigational product. Participants with prior
treatment such as, but not limited to, imatinib, isotretinoin, garetosmab or
palovarotene may be enrolled 30 days after discontinuation or after washout of at
least 5 half-lives, whichever is longer.

- Participants must be able to perform pulmonary function tests adequately and reliably.

- Participants must be able to have an adequate echocardiography assessment at screening
for evaluation of left ventricular structure and function as defined by the protocol.

- Participants must be accessible for treatment and follow-up and be able to undergo all
study procedures. Participants living at distant locations from the investigational
site must be able and willing to travel to a site for the initial and all on-site
follow-up visits. Participants must be able to undergo low-dose WBCT (excluding head)
without sedation.

- Body weight ≥10 kg.

- Abstinent or using two highly effective forms of birth control. Females must also have
a negative blood or urine pregnancy test prior to administration of study drug.

Key
Exclusion Criteria:


- Participants with complete heart block and left bundle branch block on screening
electrocardiogram.

- Participants with screening echocardiography showing septal or left ventricular free
wall thickness >12 mm for adult participants or a z-score >3 compared with population
norms for children and adolescent participants or left ventricular ejection fraction
(LVEF) <50%.

- Participants with severe mitral or tricuspid regurgitation on echocardiography at
screening.

- Participants with significant underlying lung disease requiring supplementary oxygen
or forced vital capacity <35% of predicted at screening.

- Participants with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal,
endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or another significant
disease as judged by the investigator.

- Participants with severe hepatic impairment.

- Concomitant medications that are strong inhibitors (including grapefruit juice) or
inducers (including St John's Wort) of cytochrome P450 (CYP) 3A4 activity; or kinase
inhibitors such as imatinib.

- Prior use in the past year and concomitant use of bisphosphonates for participants in
the PET-CT sub study.

- Concurrent participation in another interventional clinical study, or a
noninterventional study with radiographic measures or invasive procedures (e.g.
collection of blood or tissue samples).

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

- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5×ULN.

- Participants with hematologic abnormalities:

- Hgb<10g/dL

- Platelets<75,000/mm3

- WBC<2000/mm3

- Participants with coagulation test measurements outside of the normal range at
screening.

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

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
BLU-782, Progressive myositis ossificans
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A2B101-1, BASECAMP-1: Observational Protocol Obtaining Solid Tumor Tissue from Subjects with Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing

A2B101-101: Obtaining Primary Solid Tumor Tissue from Subjects Having Primary Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing

Julian Molina
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305746-P01-RST
21-009252
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Inclusion Criteria
•Part 1:

  • Able to provide written informed consent.
  • Pathologically confirmed solid tumors; e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Gastric and Esophageal Cancer, Ovarian Cancer, Mesothelioma, Breast Cancer, or Head and Neck Cancer and in the Investigator’s opinion the subject is high risk for incurable relapse within two years.
  • Age ≥ 18 years.

Exclusion Criteria
•Part 1:

  • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  • Prior allogeneic stem cell transplant.
  • Prior solid organ transplant.
  • In the investigator’s judgement, the subject is unlikely to complete all protocol required study visits, including hospitalization, study visits and procedures, and follow up visits, or comply with the study requirements for participation. 

Eligibility Criteria
•Part 2:

  • Able to provide written informed consent.
  • Pathologically confirmed solid tumors; e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Gastric and Esophageal Cancer, Ovarian Cancer, Mesothelioma, Breast Cancer, or Head and Neck Cancer and in the Investigator’s opinion the subject is high risk for incurable relapse within two years.
  • Age ≥ 18 years.
  • Subjects are germline HLA-A*02 heterozygous confirmed by HLA typing.
  • Primary tumor tissue showing LOH of HLA-A*02 by NGS.
  • Adequate bone marrow reserve, hematological, renal and hepatic function defined as: 
    • Hemoglobin > 9.0 g/dL;
    • ANC 800/µl;
    • Platelet count > 80,000/µl;
    • Serum Creatinine <1.5 x ULN;
    • Calculated Creatinine Clearance > 60 ml/min;
    • Total Serum Bilirubin < 2 x ULN;
    • ALT< 5 x ULN;
    • AST< 5 x ULN.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 1.
  • Baseline oxygen saturation > 92% on room air.
  • No clinically significant pleural effusion.

Exclusion Criteria
•Par 2:

  • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  • Prior allogeneic stem cell transplant.
  • Prior solid organ transplant.
  • Presence of any indwelling catheter or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal, pericardial catheter).  Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
  • Subjects who have received any cancer therapy (investigational agent or not), including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 3 weeks of planned leukapheresis or 5 half-lives, whichever is shorter.
  • Has a diagnosis of immunodeficiency or autoimmune disease requiring continued systemic therapy (e.g., monoclonal antibody therapy).
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to completion of antibiotic course).
  • Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon sponsor agreement.
  • Known or suspected chronic, active Epstein Barr Virus (EBV).
  • Has known active history of or screened positive for Human Immunodeficiency Virus (HIV).
  • Has known active history of or screened positive for Hepatitis B (HBsAg positive) or C (anti-HCV positive).
  • Unstable angina, myocardial infarction, cardiac angioplasty or stenting, or any other significant cardiac disease within the last 6 months.
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
  • Requires supplemental home oxygen.
  • Significant pulmonary disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or obstructive pulmonary disease).
  • Females of childbearing potential who are pregnant or breastfeeding.
  • In the investigator’s judgement, the subject is unlikely to complete all protocol required study visits, including hospitalization, study visits and procedures, and follow up visits, or comply with the study requirements for participation. 

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

 

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A ProspecTive Prevalence Study in Adolescent and Adult Patients Dependent on Parenteral Nutrition to Assess tHe Incidence of Intestinal FailuRe-AssocIated LiVer DiseasE (THRIVE-1)

Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition (THRIVE-1)

Manpreet Mundi
All
12 years to 80 years old
This study is NOT accepting healthy volunteers
2021-305761-P01-RST
21-009120
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Inclusion Criteria:


- The participant and/or their parent/Legally Authorized Representative is willing and
able to provide signed informed consent or assent as appropriate

- Male or female adults 18 to 80 years of age, or adolescents 12 to 17 years of age

- Patients dependent on parenteral nutrition (PN) that receive PN for an average ≥ 4
days a week for 10 weeks or longer prior to screening to meet nutritional, caloric,
fluid, and/or electrolyte needs

- The Investigator expects no changes in the lipid, dextrose, amino acid, or vitamin
regimen to be medically necessary during the participant's participation in the study

- Willingness of participant to maintain his/her current habitual oral diet and fluids
regimen for the study duration


Exclusion Criteria:


- Participants taking steatogenic medications for ≥12 weeks in the past 12 months (e.g.,
amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids,
over the usual dose of estrogen for hormone replacement therapy, and valproate); those
taking any medicine (e.g., metformin, thiazolidinediones, ursodeoxycholic acid,
pentoxifylline, S-adenosyl-L-Methionine, and betaine) that could affect the
measurement of IFALD within 12 weeks prior to study entry

- Participants taking potential hepatotoxic medications that in the judgement of the
Investigator is causing hepatic abnormalities

- Participants with a cardiac pacemaker, intravascular stents, other metallic devices,
and claustrophobia which are contraindicated to magnetic resonance imaging

- Participants who took choline supplements or choline-containing multivitamins within
14 days of screening

- History of major organ transplant (e.g., heart, kidney, liver, etc.)

For more information on eligibility criteria, please contact the sponsor.

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

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

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Validation and Reliability of a Single Operator Technique for Stress Sonography in Healthy Elbow Medial Ulnar Collateral Ligaments (UCLUS)

Ulnar Ligament Ultrasound Stress Test

Jacob Sellon
Male
18 years to 40 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305767-H01-RST
21-009058
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Inclusion Criteria:

  • Males, age 18-40 years old.
  • Staff members and trainees within the Sports Medicine Division and Physical Medicine and Rehabilitation Departments of Mayo Clinic.


Exclusion Criteria:

  • Individuals under 18 or over 40 years old.
  • Prior or current history of elbow joint pain, injury, or surgery such as elbow joint arthritis, prior/current elbow ulnar collateral ligament injury that required subject to take time off from sport, or history of any elbow surgery.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

 

Orthopedic US scan, Ultrasonography of forearm, Ultrasonography of joint of upper extremity, Diagnostic Test
Elbow instability, Joint instability
Elbow joint unstable, Ultrasound, Musculoskeletal system
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Prospective Observational Study of Patient-Reported and Clinical Outcomes Among Patients with Triple-Class Refractory Multiple Myeloma (TCR MM) (A MagnetisMM-Real World [RW] Study) (MagnetisMM-RW)

A study of how current treatments impact the course of relapsed myeloma and the effect of the treatments on the quality-of-life measurements.

Shaji Kumar
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305783-P01-RST
21-009198
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Inclusion Criteria:

  • Male or female age ≥ 18 years.
  • Prior diagnosis of multiple myeloma according to IMWG criteriaa , and measurable disease.
  • Relapsed MM refractory to at least one IMiD, PI, and anti-CD38 antibody; patient does not need to be refractory to all three classes of treatment in the same LOT in order to be eligible.
    • Note: Refractory is defined as having progressive disease (PD) while on therapy or within 60 days following treatment.
    • Note: PD will be defined as one or more of the following based on the 2016 IMWG consensus criteria for response and minimal residual disease assessment in MM:
      • Increase of 25% from lowest confirmed response value in one or more of the following criteria:
      • Serum M-protein (absolute increase must be ≥ 0.5 g/dL);
      • Serum M-protein increase ≥ 1 g/dL, if the lowest M component was ≥ 5 g/dL;
      • Urine M-protein (absolute increase must be ≥ 200 mg/24 h);
      • In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be > 10 mg/dL);
      • In patients without measurable serum and urine M-protein levels and without measurable involved FLC levels, bone marrow plasma-cell percentage irrespective of baseline status (absolute increase must be ≥ 10%);
      • Appearance of a new lesion(s), ≥ 50% increase from nadir in the sum of the products of the maximal perpendicular diameters of measured lesions of > 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion > 1 cm in short axis; ≥ 50% increase in circulating plasma cells (minimum of 200 cells per µL) if this is the only measure of disease.
  • Relapsed or refractory to last anti-MM regimen.
  • ECOG performance status ≤ 2.
  • Receiving subsequent treatment after becoming TCR (but not necessarily the first subsequent treatment), where initiation of this treatment will define the index date.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • * If application of International Myeloma Working Group (IMWG) criteria for diagnosis of MM or assessment of response is not available as part of regular clinical practice, clinician assessment may be used. The specific criteria used will be documented in the case report form.


Exclusion Criteria:

  • Diagnosis of current smoldering MM, active plasma cell leukemia, amyloidosis, and Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome.
  • Prior stem cell transplant within 12 weeks prior to study enrollment or active graft-versus-host-disease (GVHD).
  • Any other active malignancy within 3 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • No investigational drug within 30 days or 5 half-lives preceding the index date, and throughout course of the study.
  • Prior or concomitant treatment with an anti-BCMA bispecific antibody, including PF-06863135.
  • Currently pregnant or breastfeeding.
    • Note: Additional inclusion/exclusion criteria may be applied in a sensitivity analysis to more closely match the Phase 2 MagnetisMM-3 (study C1071003) trial population depending on available data.
  • The following information will be collected at the time of enrollment to the extent data are available. Laboratory measurements will be based on the most recent reading at the time of enrollment:
    • Left ventricular ejection fraction (LVEF) > 40% by a multigated acquisition (MUGA) scan or echocardiogram (ECHO);
    • Adequate hepatic function;
    • Total bilirubin < 2 x upper limit of normal (ULN) (< 3 x ULN if documented Gilbert’s syndrome);
    • Aspartate transaminase (AST) < 2.5 x ULN; and
    • Alanine aminotransferase (ALT) < 2.5 x ULN;
    • Adequate renal function;
    • Creatinine clearance > 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method;
    • Adequate bone marrow function o Absolute neutrophil count (ANC) > 1.0 x 10^9 /L;
    • Platelets > 25 x 10^9 /L; and
    • Hemoglobin > 8 g/dL;
    • Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) Grade < 1.
  • History of impaired cardiovascular function or clinically significant cardiovascular diseases (CVD), defined as any of the following within 6 months prior to study enrollment:
    • Acute myocardial infarction (AMI) or acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
    • Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
    • Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
    • Prolonged QT syndrome (or triplicate average QTc corrected using Fridericia’s formula [QTcF] > 470 msec at screening);
    • Presence of ongoing Grade > 2 peripheral sensory or motor neuropathy;
    • History of any grade peripheral sensory or motor neuropathy, collected among patients with prior BCMA-directed therapy;
    • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade > 3 peripheral motor polyneuropathy.
  • Presence of surgical (including major surgery within 14 days prior to study enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the individual inappropriate for the study.
  • Presence of active hepatitis B virus (HBV), hepatitis C virus (HCV), SARS-CoV-2, human immunodeficiency virus (HIV), or uncontrolled infection. Active infections must be resolved at least 14 days prior to study enrollment.
  • Prior treatment with investigational drug within 30 days or 5 half-lives preceding the index date.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Single-cell Gastric Epigenomics and Transcriptomics in Humans

Gastric Epigenome and Transcriptome in Humans

Adil Bharucha
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305786-H01-RST
20-012002
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Inclusion Criteria:

  • Male or female patients, aged 18 years and older.
  • Scheduled to undergo gastric surgery for obesity.
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.
  • Medications. Opiates and high doses of anticholinergic agents (e.g., amitriptyline greater than 50 mg daily).
  • Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.

Eligibility last updated 9/1/21. Questions regarding updates should be directed to the study team contact.

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A Novel Mechanism of Hidradenitis Suppurativa: A Neuroendocrine Interaction Between Mast Cells, HPA Axis and Endocannabinoid System

Neuroendocrine System in HS

Afsaneh Alavi
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2021-305802-P01-RST
21-007888
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Inclusion Criteria:

  • Male or female, at least 18 years old.
  • Subjects with diagnosis of Hidradenitis Suppurativa (HS) and at least one active inflammatory lesion (nodule, abscess or tunnel) and has indication for deroofing or surgery.
  • Subject must be in general good health without uncontrolled significant co-morbid conditions (except for hidradenitis suppurativa) as judged by the investigator, based on medical history.
  • Has/will have undergone surgery for HS treatment at the Department of Dermatology, Mayo Clinic between September 2021 and December 31, 2022


Exclusion Criteria:

  • Individuals < 18 years old.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

 

 

 

 

 

 

Inclusion Criteria:

-           -          

 

 

 


Exclusion Criteria:
 

  • Current use of any biologics, mast cell stabilizer or investigational drug within 4 weeks prior to skin sample, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
  • Patients who have the comorbidities listed below:
    • Mast cell disorder
    • Active infection
    • Malignancy
    • Pregnancy
    • Major dermatitis (e.g. atopic dermatitis, psoriasis)
  • Patients whose records are incomplete

 

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The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S™) in the Treatment of Post-Covid Symptoms

Mindfulness Intervention for Post-Covid Symptoms

Ivana Croghan
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-305823-H01-RST
21-009820
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Inclusion Criteria:
 

  • 18 years of age or older at time of consent.
  • Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester:  
    • fatigue-predominant  (N=20);
    • pain-predominant  (N=20); 
    • orthostasis-predominant  (N=20).
  • Not pregnant by subject self-report at time of consent.
  • Have the ability to provide informed consent.
  • Have the ability to complete all aspects of this trial.
  • Have access to an iPhone, iPad, or Android device.  
  • Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators.


Exclusion Criteria:
    

  • Individuals < 18 years old.
  • Used an investigational drug within the past 30 days.
  • Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
  • Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
  • Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients’ QOL, or stress.
  • An unstable medical or mental health condition as determined by the physician investigator.

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

 

Device
Coronavirus disease 2019, General infectious diseases, Post-COVID-19 syndrome
COVID-19, Chronic post-COVID-19 syndrome, Disease caused by 2019 novel coronavirus, Post-acute COVID-19, Respiratory system
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A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients with Neovascular Age-Related Macular Degeneration

UBX1325 for Treatment of Neovascular ARMD

Matthew Starr
All
50 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305828-P01-RST
21-009324
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Inclusion Criteria:

  • Patients aged ≥ 50 years.
  • Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening with either the CNV or fluid involving the center of the fovea.
  • Neovascular AMD patients who have had at least 3 anti-VEGF treatments in the study eye in the preceding 6 months prior to Screening, no less often, than approximately every 2 months
  • BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1. On Day 1, BCVA cannot be 10 or more letters from Screening:
    • Note: if both eyes are eligible, the one with the poorer BCVA should be chosen. If BCVA is equal, the eye with the greatest potential for vision gains, in the opinion of the Investigator, should be selected.
  • BCVA in the non-study eye of 35 ETDRS letters (equivalent to 20/200 on the Snellen chart) or better.
  • IOP ≤ 23 mmHg in the study eye.
  • Clear ocular media and adequate pupillary dilation to permit CFP, SD-OCT, and adequate BCVA evaluation.
  • Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.


Exclusion Criteria:

  • Concurrent disease in the study eye or structural damage, other than nAMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye. This includes, but is not limited to, the following:
    • Macular edema of etiologies other than nAMD;
    • Clinically significant subretinal fibrosis;
    • Subfoveal lipid with atrophy involving center of fovea;
    • Cataract requiring surgery during the study period;
    • RPE atrophy or tear or rips involving the macula;
    • Presence of macular hole;
    • History of uveitis;
    • Vitreomacular traction;
    • Clinically significant epiretinal membrane (ERM);
    • Aphakia or Anterior Chamber Intraocular Lens (A/C IOL);
    • Other retinovascular disease.
  • Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to Screening (mild blepharitis is acceptable)
  • Subretinal hemorrhage with bleeding area ≥ 4 disc area in the study eye
  • History of vitrectomy in the study eye
  • History of intraocular, periocular, or corneal surgery in the study eye within 3 months prior to screening, or anticipated need for such surgery during the study
  • History of panretinal photocoagulation (within 6 months) or macular laser photocoagulation (within 3 months) in the study eye prior to Day 1
  • History of corneal transplant in the study eye
  • Concomitant use of > 2 medications for the treatment of glaucoma and unstable glaucoma in the study eye (i.e., inadequate IOP control). Combination drugs, if given in a single drop, are considered 2 medications
  • Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
  • Presence of severe myopia (-8 diopters or greater) in the study eye
  • The use of intraocular steroids in the study eye within the last 2 years prior to screening
  • History of Visudyne® photodynamic therapy in the study eye
  • Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus imaging 
  • Intraocular surgery, including cataract surgery, in the study eye ≤ 3 months of screening
  • Known allergy to any component (phosphate buffered saline and polysorbate 80) of the Study Drug or to any component of Aflibercept, or a clinically relevant sensitivity to fluorescein dye
  • Female patients who are pregnant, lactating, or of childbearing potential who do not agree to use highly effective methods of birth control (e.g., progesterone-only hormonal contraception, double barrier, or intrauterine device) during the study and for 3 months following the last dose of Study Drug. Postmenopausal females (> 45 years old and without menses for more than 1 year) and surgically sterilized females are exempt from these requirements.
  • Male patients who do not agree to use a highly effective method of contraception during the study and for 3 months following the last dose of Study Drug, if sexually active with a female partner of childbearing potential.
  • Patients who within 3 months of screening received or are concurrently on another investigational drug or vaccine study, including patients who previously received treatment in a UBX1325 study. Coronavirus Disease 2019 (COVID-19) vaccinations are permitted prior to or during the course of the study.
  • Any uncontrolled medical condition, in the opinion of the Investigator, would preclude participation in this study, including, but not limited to, history of malignancy within the last 3 years (however, non-facial, basal cell carcinoma is allowed), history of myocardial infarction within the last 6 months, or concomitant therapy.

Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.

 

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DCC-3014-03-001: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION) (MOTION)

Phase 3 Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Scott Okuno
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305844-P01-RST
21-009962
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Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening).
  • Symptomatic disease as defined as at least moderate pain per BPI Worst Pain or at least moderate stiffness per Worst Stiffness NRS item (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period, prior to the first dose, and documented in the medical record.
  • Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol.
  • Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug.
  • Must have at least 1 measurable lesion according to RECIST Version 1.1, with a minimum tumor size of 2cm.
  • Adequate organ and bone marrow function.
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
  • Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
  • Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device.


Exclusion Criteria:

  • Previous use of systemic therapy targeting colony stimulating factor 1 (CSF1) or CSFR1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed.
  • Received therapy for TGCT, including investigational therapy within 14 days prior to the administration of study drug or within 28 days for therapies with a half-life longer than 3 days or an unknown half-life prior to the administration of study drug.
  • Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis).
  • QT interval corrected by Fridericia's formula (QTcF) > 450 ms in males or > 470 ms in females or history of long QT syndrome.
  • Concurrent treatment with any study-prohibited medications.
  • Major surgery within 14 days of the first dose of study drug.
  • Any clinically significant comorbidities.
  • Active liver or biliary disease including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis.
  • Malabsorption syndrome or other illness that could affect oral absorption.
  • Known active human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or known active mycobacterium tuberculosis infection.
  • If female, the participant is pregnant or lactating.
  • Known allergy or hypersensitivity to any component of the study drug.
  • Contraindication to MRI.
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A Randomized, Double-blind, Placebo Controlled, Dose Escalation Pilot Study Evaluating the Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial lung disease-related Cough (MACS-02)

Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough (MACS-2)

Vivek Iyer
All
18 years to 85 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305848-H01-RST
21-009475
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Inclusion Criteria:

Subjects who meet all the following criteria will be eligible for the study:

  • Women and men between 18 and 85 years of age.
  • Have a diagnosis of interstitial lung disease (ILD) according to the American Thoracic Society Guidelines.
  • Have a chronic cough for at least 3 months prior to the screening visit.
  • Patients should be on a stable dose of ILD-directed therapies for 3 months prior to enrollment and will be allowed to continue their ILD-directed therapies. These include –but are not limited to- corticosteroids, immunosuppressing agents such as azathioprine and mycophenolate, as well as antifibrotic medications including nintedanib and pirfenidone. Additional corticosteroids and adjustment of ILD-directed therapy doses is permitted if deemed appropriate by the treating physician.
  • Have a score of ≥ 40mm on the Cough Severity VAS at Screening..
  • Women of child-bearing potential must use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
  • Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
  • Have provided written informed consent.
  • Are willing and able to comply with all aspects of the protocol.


Exclusion Criteria:

Subjects are NOT eligible for this study if they meet any of the following criteria:

  • Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have smoked within the past 12 months.
  • Former smokers with > 20 pack-year history of smoking.
  • Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a subject’s cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0).
  • History of opioid use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for example, to treat pain) is permitted.
  • History of baclofen use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications (for example, to treat spasticity) is permitted.
  • Presence of an untreated or undertreated cause (other than ILD) for the patient’s chronic cough (per ACCP guidelines). e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain the patient’s chronic cough.
  • Requiring concomitant therapy with prohibited medications.
  • Treatment with any pharmaceutical or biological investigational therapy (excluding COVID vaccination and COVID related monoclonal antibody therapy).
  • Participation in another clinical trial that does not allow co-enrollment within 4 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) during screening.
  • Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis.
  • Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal hypertension.
  • History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline (patients who have previously been on either amitriptyline or duloxetine for chronic cough or other reasons and have tolerated the medication will be offered participation regardless of previous response to therapy).
  • Currently pregnant or breastfeeding female subject.
  • Presence of any medical condition or disability that the investigators believe could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended travel) during the subject’s participation in the study. 
  • Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot safely discontinue at least 2 weeks prior to the screening period.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY) (REGENCY)

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

Fernando Fervenza
All
18 years to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305850-P01-RST
21-010402
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Inclusion Criteria:

  • Signed Informed Consent Form.
  • Age 18-75 years at time of signing Informed Consent Form.
  • Ability to comply with the study protocol, in the investigator's judgment.
  • Active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN by renal biopsy performed in the 6 months prior to screening or during screening:
    • One or more active glomerular lesions must be present;
    • Class V disease may be present in addition to Class III or IV;
    • The local biopsy report will be used to determine eligibility.
  • SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III or IV LN (above) and current or past positive antinuclear antibody (ANA) Positive ANA is defined by ANA at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive ANA test at least once. UPCR ≥ 1 on a 24-hour collection at screening
  • Receipt of at least one dose of pulse methylprednisolone IV (≥ 250 mg) or equivalent for treatment of the current episode of active LN during the 6 months prior to screening or during screening, or to be given on Day 1 prior to the first infusion.
    • A maximum of 3 g methylprednisolone IV or equivalent during the 4 weeks prior to screening or during screening is allowed.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception, as defined below: Women must remain abstinent or use two reliable methods of contraception, including at least one method with a failure rate of < 1% per year, during study treatment and for 18 months after the final dose of obinutuzumab or placebo and 6 weeks after the final dose of MMF. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation; male sterilization; established, proper use of hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method used by the female partner that together result in a failure rate of < 1% per year during the treatment period and for 90 days after the final dose of MMF. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.


Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo or within 6 weeks after the final dose of MMF.
  • Women of childbearing potential, including those who have had a tubal ligation, must have a negative urine pregnancy test at screening. Positive test results will be confirmed with a serum pregnancy test. Severe renal impairment, as defined by eGFR < 30 mL/min/1.73 m^2 (as estimated using the CKD-EPI equation) or the need for dialysis or renal transplantation.
  • Sclerosis in > 50% of glomeruli on renal biopsy.
  • Presence of rapidly progressive glomerulonephritis, defined by any of the following:
    • Crescent formation in ≥ 50% of glomeruli assessed on renal biopsy;
    • Sustained doubling of serum creatinine during the 2 months prior to screening;
    • The investigator’s opinion that the patient has rapidly progressive glomerulonephritis.
  • Receipt of any of the following excluded therapies:
    • Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 9 months prior to screening or during screening;
    • If an anti-CD20 therapy has been received between 9 and 12 months prior to screening, the peripheral CD19+ B-cell count must be ≥ 25 cells/µL;
    • Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening;
    • Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening;
    • Oral inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening;
    • Any live vaccine during the 28 days prior to screening or during screening.
  • Severe, active central nervous system SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia.
  • High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions.
  • Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation.
  • HIV infection:
    • For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.
  • Tuberculosis (TB) infection:
    • Testing for latent TB will be performed at screening if required by local regulations or in accordance with local clinical practice;
    • Latent TB after completion of appropriate treatment is not exclusionary.
  • Active infection of any kind, excluding fungal infection of the nail beds.
  • Any major episode of infection that also fulfills any of the following criteria:
    • Requires hospitalization during the 8 weeks prior to screening or during screening;
    • Requires treatment with IV antibiotics or anti-infectives during the 8 weeks prior to screening or during screening;
    • Requires treatment with oral antibiotics or anti-infectives during the 2 weeks prior to screening or during screening:
      • Antibiotics or anti-infectives given in the absence of a major episode of infection are not exclusionary.
  • History of serious recurrent or chronic infection.
  • History of progressive multifocal leukoencephalopathy (PML).
  • History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years:
    • Patients with non-melanomatous carcinomas of the skin that have been treated or excised and have resolved are eligible.
  • Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening.
  • Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening.
  • Intolerance or contraindication to study therapies, including any of the following:
    • History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion;
    • Intolerance or contraindication to oral or IV corticosteroids;
    • Intolerance to MMF;
    • Lack of peripheral venous access.
  • Any of the following laboratory parameters:
    • AST or ALT > 2.5 x ULN;
    • Amylase or lipase > 2 x ULN;
    • Neutrophils < 1.5 x10^3 /µL;
    • Positive hepatitis B surface antigen (HBsAg);
    • Patients who are HBsAg negative and hepatitis B core antibody (HBcAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring until 12 months after the last dose of obinutuzumab or placebo.
  • Positive hepatitis C serology Patients with positive hepatitis C antibody test result with no detectable hepatitis C virus (HCV) RNA at least 6 months after completion of antiviral therapy are eligible but will require monthly HCV RNA monitoring until 12 months after the last dose of obinutuzumab or placebo.
  • Hemoglobin < 7 g/dL, unless caused by autoimmune hemolytic anemia resulting from SLE.
  • Platelet count < 25,000/µL.
  • Positive serum human chorionic gonadotropin measured at screening.

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

 

 

Biologic/Vaccine, Other
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A Randomized, Placebo-controlled, Double-blind, Multi-center Phase 2/3 Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients with Symptomatic Polycystic Liver Disease (HS-20-677)

A Randomized, Placebo-controlled, Double-blind, Multi-center Phase 2/3 Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients with Symptomatic Polycystic Liver Disease

Marie Hogan
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-305857-P01-RST
21-009647
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Inclusion Criteria:

  • Voluntary and valid written informed consent to participate in the trial provided by the patient before any trial related procedures are performed.
  • Male or female patient, ≥ 18 years at screening.
  • Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥ 2500 mL/m at screening.
  • Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen.
  • Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial.
  • Female patients of childbearing potential must be willing to use an acceptable method of contraception from screening and during the entire trial.
  • Male patients must be willing to use condom as method of contraception from screening and throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).


Exclusion Criteria:

  • Surgical intervention for PLD within 3 months before screening.
  • Treatment with an SSA within 3 months before screening.
  • Non-responsive to previous treatment of PLD with an SSA as per the Investigator’s assessment.
  • Cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy.
  • Presence of extrahepatic cysts that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial.
  • Severe kidney disease, as defined by estimated glomerular filtration rate (eGFR) 160 mmHg and/or diastolic blood pressure of >100 mmHg at screening.
  • Severe liver disease defined as liver cirrhosis of Child-Pugh class C.
  • Use of oral contraceptives or estrogen supplementation within 3 months before screening.
  • Poorly controlled diabetes (hemoglobin A1c ≥ 10%) at screening.
  • Patients with a known history of hypothyroidism, unless they have been on adequate and stable replacement thyroid hormone therapy for at least 3 months before the first dose of the IMP.
  • Uncontrolled hypertension defined by a systolic blood pressure of > 160 mmHg and/or diastolic blood pressure of > 100 mmHg at screening
  • History of significant cardiac disease or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following:
    • History of myocardial infarction, angina pectoris or coronary artery bypass graft within 6 months before screening;
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block or high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II and third-degree atrioventricular block);
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
    • Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia;
    • Treatment with concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives or 7 days (whichever is longer) before the first dose of IMP;
    • Patients with a baseline QTc interval corrected by Fridericia's formula (QTcF) > 450 msec for males and > 470 msec for females at screening.
  • Patients with vascular compromise, including, but not limited to, mesenteric thrombosis, portal hypertension and thrombocytopenia (platelet counts less than 100 x 10^9 /L).
  • Pregnant, lactating or planning to be pregnant during the trial.
  • Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in the trial.
  • History of solid organ transplantation.
  • Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or other components of CAM2029, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient.
  • Contraindications to, or interference with, MRI assessments, as dictated by local hospital regulations.
  • Previously treated/randomized in the current clinical trial.
  • Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening or during the trial.
  • Any other contraindicated serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial.
  • Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator.
  • Unwilling or unable to comply with the requirements of the protocol or in a situation or condition that, in the opinion of the Investigator, may interfere with participation in the trial.
  • On the staff, affiliated with, or a family member of the personnel directly involved with this trial.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC) (ATTACC)

Study of RP-3500 With Niraparib or Olaparib in Advanced Solid Tumors

Siddhartha Yadav
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305858-P01-RST
21-009516
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Inclusion Criteria:


- Male or female and ≥18 years-of-age at the time of signature of the informed consent

- Confirmed advanced solid tumors resistant or refractory to standard treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

- Evaluable disease as per RECIST v1.1

- Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent
laboratory demonstrating eligible tumor biomarkers.

- Submission of available tumor tissue or willingness to have a biopsy performed if safe
and feasible

- Acceptable hematologic and organ function at screening

- Negative pregnancy test for women of childbearing potential at Screening and prior to
first study drug.

- Ability to swallow and retain oral medications.


Exclusion Criteria:


- Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.

- Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10
days or 5 half-lives (whichever is longer), prior to first dose of study drug.

- Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose
of study drug.

- History or current condition, therapy, or laboratory abnormality that might confound
the study results, or interfere with the patient's participation for the full duration
of the study treatment.

- No other anticancer therapy is to be permitted while the patient is receiving study
treatment.

- Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study
treatment dose.

- Uncontrolled, symptomatic brain metastases.

- Uncontrolled high blood pressure

- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis

- Presence of other known active invasive cancers.

- Pregnant or breastfeeding women.

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the study protocol and/or follow-up procedures outlined in the
protocol.

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

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

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Electrophysiologic and Biosensor Signal Analysis of Patients and Controls (PSA)

Electrophysiologic and Biosensor Signal Analysis of Patients and Controls

Erik St. Louis
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305864-H01-RST
21-010416
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Inclusion Criteria:

Subjects

  • Clinically or genetically confirmed diagnosis of a neurological, psychiatric, or medical condition of interest.
  • Age ≥ 18 years at time of diagnosis.

Controls

  • Healthy control participants, either a convenience sample of patient’s friends, acquaintances, or family members; or alternatively, community controls, or control outpatients seen at Mayo Clinic.
  • Age ≥ 18 years at time of survey.


Exclusion Criteria:

Subjects

  • Age < 18 years at time of diagnosis.
  • Inadequate familiarity with the English language.
  • Presence of any medical condition or surgical history that could affect the safety of the subject or interfere with study assessments, safety, or the ability of the subject to complete the evaluation per the judgment of the site principal investigator.

Controls

  • Age < 18 years at time of survey.
  • Inadequate familiarity with the English language.
  • Presence of any medical condition or surgical history that could affect the safety of the subject or interfere with study assessments, safety, or the ability of the subject to complete the evaluation per the judgment of the site principal investigator.
  • Personal history of the neurological, psychiatric, or medical conditions being studied.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

 

 

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MC210601 Phase II Clinical Trial of PLX038 in Patients with Platinum-resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancer

PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305866-P01-RST
21-012233
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Inclusion Criteria
•Registration:

  • Age ≥ 18 years.
    • NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
  • Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as “ovarian cancer”).
  • Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant.
  • No more than one prior line of therapy for platinum resistant disease.
    • NOTE: Prior PARP inhibitor therapy is allowed.
  • Measurable disease per RECIST 1.1.
  • Disease that is amenable to two biopsies.
  • Life expectancy greater ≥ 12 weeks.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • The following laboratory values obtained ≤ 28 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement);
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.

Exclusion Criteria
•Registration:

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

  • Pregnant persons.
  • Nursing persons.
  • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Histology other than high grade serous carcinoma.
  • Prior treatment restrictions.
  • Chemotherapy ≤ 4 weeks prior to registration.
  • Immunotherapy ≤ 4 weeks prior to registration.
  • Radiotherapy ≤ 4 weeks prior to registration.
  • Any other investigational therapy ≤ 4 weeks prior to registration.
  • History of prior or concurrent malignancy ≤ 2 years prior to registration.
    • Exceptions: If natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Myocardial infarction within 6 months of study entry;
    • NYHA class III or IV heart failure;
    • Uncontrolled dysrhythmias or poorly controlled angina;
    • History of serious ventricular arrhythmia (VT or VF) and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of Long QT syndrome).
  • Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents.
    • Exception: Patients should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better.
  • Known HIV.
    • Exception: Patients on effective anti-retroviral therapy with undetectable viral load ≤ 6 months prior to registration are eligible for this trial.
  • Known hepatitis.
    • Exception: For patients with evidence of chronic hepatitis B virus infection the HepB viral load must be undetectable on suppressive therapy, if indicated, to be eligible.
    • Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • Receiving any other investigational agent.
  • History of clinically significant gastrointestinal bleeding, colitis, or gastrointestinal perforation.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Requirement for anticoagulation treatment that increases INR or APTT above the normal range.
    • Exceptions: low dose DVT or line prophylaxis allowed.
  • Known CNS disease.
    • Exception: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression.
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determined that immediate CNS specific treatment is not required and is unlikely to be required during the 1st cycle of therapy.
  • Known Gilbert's syndrome or homozygous for the UGT1A1*28 variant allele or other relevant alleles with severely reduced UGT1A1 activity.
  • Patients who require treatment with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038.
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MarkVCID Validation in the General Community (MarkVCID2)

Validation of MarkVCID in the General Community

Ronald Petersen
All
60 years to 90 years old
This study is NOT accepting healthy volunteers
2021-305868-H01-RST
21-009529
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Inclusion Criteria:

  • Male or female.
  • Aged 60 to 90 years, inclusive at Visit 1 Screen.
  • Clinical diagnosis of normal cognition, subjective cognitive decline, mild cognitive impairment or mild dementia ( CDR® ≤ 1.5).
  • Fluent in English or Spanish.


Exclusion Criteria:

  • Contraindications to MRI such as inability to fit inside the MRI scanner, difficulty with close or confined spaces or presence of MRI non-compatible implants such as pacemakers or aneurysm clips.
  • History of or current neurologic, psychiatric or medical disease that could confound the results of the study tests and procedures.
  • Clinical diagnosis of moderate or severe cognitive impairment or dementia, requiring assistance with basic activities of daily living.

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

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Shared Decision Making For Patients Living With Fibromyalgia

Shared Decision Making For Fibromyalgia Patients

Arya Mohabbat
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305869-H01-RST
21-010359
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Inclusion Criteria
•Patients:

  • Patient age 18 or above.
  • Confirmed diagnosis of fibromyalgia (FM).
  • Patient must be able to understand and provide informed consent and HIPAA authorization.
  • Able to speak and read English.

Exclusion Criteria
•Patients:

  • Patients < 18 years of age.
  • Inability to provide informed consent or HIPAA authorization.
  • Individuals that decline study participation.
  • Patients without a confirmed diagnosis of FM.

Inclusion Criteria
•Clinicians:

  • Clinicians providing care to eligible patients at the Fibromyalgia Clinic and division of General Internal Medicine (Mayo Clinic Jacksonville and Rochester).

Exclusion Criteria
•Clinicians:

  • Individuals that decline study participation.

Eligibility last updated 10/1/21. Questions regarding updates should be directed to the study team contact.

 

 

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    Mayo Clinic — Rochester, MN

    Quantitative Analysis of Short-Term Follow-Up CT Scan in Patients Undergoing Bronchoscopic Lung Volume Reduction (BLVR) with Endobronchial Valves

    Postprocedural CT Scan in Patients Undergoing Bronchoscopic Lung Volume Reduction with Endobronchial Valves to Determine Benefit or Adverse Effects

    Tobias Peikert
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305871-H01-RST
    22-001325
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    Inclusion Criteria:

    • Age ≥ 18 years.
    • Subjects must have undergone bronchoscopic lung volume reduction with endobronchial valve(s) placement for treatment of emphysema at Mayo Clinic-Rochester within timeframe of 3/01/2022 to 2/28/2023.
    • Subjects must consent to undergoing CT scan of the chest prior to hospital discharge.


    Exclusion Criteria:

    • Previous endobronchial valve placement (i.e., undergoing secondary procedure to have additional valves placed or valves upsized).
    • Presence of large post-procedure pneumothorax, as defined by > 2 cm of air present between lung margin and chest wall measured at level of the hilum, identified prior to study CT acquisition.

    Eligibility last updated 3/1/22. Questions regarding updates should be directed to the study team contact.

    Diagnostic Test, Radiation
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    Mayo Clinic — Rochester, MN

    An Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-3745 in Participants with Glycogen Storage Disease Type 1a (GSD1a) (GSD1a)

    A Study of mRNA-3745 in Participants With Glycogen Storage Disease Type 1a (GSD1a)

    Eva Morava-Kozicz
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-305874-P01-RST
    21-009551
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    Inclusion Criteria:


    - Documented GSD1a with confirmation by genetic testing

    - Documented history of ≥1 hypoglycemic event with blood glucose <60
    milligrams/deciliter (mg/dL) (<3.3 millimoles/liter [mmol/L]) and symptoms of
    hypoglycemia in the absence of acute illness, with at least one such event in the 4
    weeks before signing the Informed Consent.


    Exclusion Criteria:


    - Liver transplant, including hepatocyte cell therapy/transplant

    - Received gene therapy for GSD1a

    - Presence of liver adenoma >5 centimeters (cm) in size

    - Presence of liver adenoma with growth of >2 cm or >5 newly diagnosed liver adenoma, in
    the previous 2 years.

    Note: Additional inclusion/exclusion criteria may apply, per protocol.

    Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.

     

     

    Drug
    Glycogen storage disease type Ia
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    Evaluation of the Hemp Serum IgE Antibody Assay for Potential Evaluation of Cannabis/CBD/Hemp-Related Product Allergy (ADL)

    Cannabis Allergy Study

    Joshua Bornhorst
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305878-H01-RST
    21-009210
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    Inclusion Criteria;

    • Individuals ≥ 18 years old.
    • Documentation by a doctor of allergic reactions upon cannabis exposure.


    Exclusion Criteria:

    • Individuals < 18 years old.
    • Currently undergoing anti-IgE drug treatment (e.g., Omalizumab).

    Eligibility last updated 12/3/21. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion with the Watchman Device: The ICE WATCHMAN study (WATCH-ICE)

    The ICE WATCHMAN Trial

    Mohamad Adnan Alkhouli
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-305887-H01-RST
    21-009613
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    Inclusion Criteria:

    • Men and women, ≥ 18 years of age.
    • The patients is eligible to undergo WATCHMAN device implant procedure.
    • The patient is eligible for short term anticoagulation therapy.
    • Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
    • Ability to give informed consent for the procedure.
    • The patient is able and willing to undergo the procedure under moderate sedation.
    • The patient is able and willing to return for required 45-day TEE.


    Exclusion Criteria:

    • Patient has contraindication for short term anticoagulation.
    • The patient has history of a hypercoagulable state per medical record documentation.
    • Pregnancy or planning to get pregnant during the investigation.

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

    Device, Procedure/Surgery
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    Mayo Clinic — Rochester, MN

    EA2201, A Phase II Study of Neoadjuvant Nivolumab Plus Ipilimumab and Short-Course Radiation in MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma (EA2201)

    Testing Nivolumab and Ipilimumab With Short-Course Radiation in Advanced Rectal Cancer

    Zhaohui Jin
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-305889-P01-RST
    21-009838
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    Inclusion Criteria:

    • Patient must be ≥ 18 years of age.
    • Patient must have histologically confirmed adenocarcinoma of the rectum with the inferior margin within 15 cm from the anal verge based on colonoscopy and/or flexible sigmoidoscopy.
    • Patient must have T3-4Nx or TxN+ disease (stage II or III) based on magnetic resonance imaging of the pelvis and computed tomography of the chest and abdomen. These baseline scans must be done within 28 days prior to registration.
    • Patient must have MSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) tumors based on immunohistochemistry or PCR (polymerase chain reaction).
    • Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
    • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
    • Patient must agree to not receive live vaccines while on this study.
    • Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for at least one month (female patients) or one week (male patients) prior to the start of study drug and continue for 5 months after the last dose of study drug (for female patients). Investigators must counsel patients on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
    • Leukocytes ≥ 3,000/mcL (must be obtained ≤ 14 days prior to protocol registration).
    • Absolute neutrophil count (ANC) ≥ 1,500/mcL (must be obtained ≤ 14 days prior to protocol registration).
    • Platelets ≥ 100,000/mcL (must be obtained ≤ 14 days prior to protocol registration).
    • Total bilirubin ≤ institutional upper limit of normal (ULN) (must be obtained ≤ 14 days prior to protocol registration).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x institutional ULN (must be obtained ≤ 14 days prior to protocol registration)
    • Creatinine ≤ 1.5 x institutional ULN (must be obtained ≤ 14 days prior to protocol registration).
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.


    Exclusion Criteria:

    • Patient must not have previously received chemotherapy or immunotherapy for rectal cancer.
    • Patient must not have previously received radiotherapy to the pelvis.
    • Patient must not have had major surgery performed within 28 days prior to registration.
    • Patient must not have a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan.
    • Patient must not have a serious active infection requiring IV antibiotics at time of registration.
    • Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible for this study because of the risk of recurrence or exacerbation of disease.
    • Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
    • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A repeat pregnancy test must be done within 72 hours prior to first dose of treatment if the baseline test was done outside the 72 hour window. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
      • has achieved menarche at some point;
      • has not undergone a hysterectomy or bilateral oophorectomy; or
      • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

    Eligibility last updated 9/14/21. Questions regarding updates should be directed to the study team contact.

    Biologic/Vaccine, Radiation
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    Location Contacts
    Mayo Clinic — Rochester, MN