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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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Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization

Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization

Erin O'Brien
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304498-H01-RST
21-004400
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Inclusion Criteria - CRSwNP:

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

 Inclusion Criteria
•wsf AERD aspirin desensitization

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

Inclusion Criteria - AERD non-Aspirin desensitization:

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

Exclusion Criteria
•All Groups:

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

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

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A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of CFT7455 in Subjects With Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma (CFT7455-1101)

A Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

Eli Muchtar
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304502-P01-RST
21-004436
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Inclusion Criteria:


1. Be willing and able to provide signed informed consent for the trial.

2. Age ≥18 years at the time of signed consent.

3. Have histologically or cytologically-confirmed NHL or MM that is r/r disease and must
not be candidates for regimens known to provide clinical benefit to be eligible for
the study.

4. MM subject must have a documented diagnosis of MM and measurable disease at
enrollment. Measurable disease is defined as:

- M-protein ≥0.5g/dL by Serum Protein Electrophoresis (sPEP) or

- ≥200mg/24-hour urine collection by Urine Protein Electrophoresis (uPEP) or

- Serum Free Light Chain (FLC) levels >100 mg/L involved light chain and an
abnormal kappa/lambda (?/?) ratio in subjects without measurable serum or urine
M-protein or

- For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be
reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥
0.50g/dL.

5. Prior treatments for MM subjects must have the following:

- Received at least 3 prior anti-myeloma regimens including at least 2 consecutive
cycles of lenalidomide, pomalidomide, a proteasome inhibitor a glucocorticoid and
an anti-CD38 antibody (induction with or without a bone marrow transplant with or
without maintenance therapy is considered one regimen).

- Refractory disease defined as disease that is nonresponsive to therapy (failure
to achieve minimal response or development of progressive disease) or disease
progression within 60 days from the last dose of their last myeloma therapy.

6. NHL subjects must have documented diagnosis of NHL and measurable disease defined by
measurable disease (consistent with Lugano classification) defined as at least one
lesion that can be accurately measured in at least two dimensions with PET-CT,
documented within 4 weeks of their projected cycle one day one (C1D1) visit. Minimum
measurement must be >15 mm in the longest diameter.

7. NHL subjects must have received the following regarding prior therapy:

- Peripheral T-cell Lymphoma: At least one prior line containing alkylator-based
chemotherapy. Note: For subjects with Anaplastic Large Cell Lymphoma (ALCL), the
subject must also have received CD30 antibody therapy.

- Mantle Cell Lymphoma: ≥2 lines of therapy, including CD20 antibody and alkylator
chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.

- Follicular Lymphoma: ≥2 lines of therapy, including CD20 antibody therapy and
alkylator chemotherapy.

- Diffuse Large B-cell Lymphoma: ≥2 lines of therapy, including prior CD20 antibody
therapy, and has received prior autologous bone marrow transplant (or is
ineligible for bone marrow transplant).

- Other NHL: Subjects must have been treated with all standard of care therapies
available to the subject which, in the assessment of the investigator, may be
beneficial to the subject.

8. A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least one of the following conditions applies:

- A woman of non-childbearing potential (i.e., physiologically incapable of
becoming pregnant) defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous
amenorrhea [in questionable cases a blood sample with simultaneous follicle
stimulating hormone (FSH) > 40 MIU/mL and estradiol < 40 pg/mL (<147 pmol/L) must
be obtained].

- Females on hormone replacement therapy (HRT) and whose menopausal status is in
doubt will be required to use one of the contraception methods specified in the
study protocol if they wish to continue their HRT during the study. Otherwise,
they must discontinue HRT to allow confirmation of postmenopausal status prior to
study enrollment.

- Agree to having ongoing pregnancy tests during the study and after
discontinuation of the study.

9. A male participant must have either had a prior vasectomy or agree to use a condom
during the treatment period and for at least 90 days after the last dose of study
treatment.


Exclusion Criteria:


1. Presence of central nervous system (CNS) disease.

2. Has received prior radiotherapy within 2 weeks of start of study treatment.

3. Have active pneumonitis.

4. Have any of the following:

- Non-secretory or oligosecretory MM

- Plasma cell leukemia

- Systemic light chain amyloidosis

- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin
changes (POEMS) Syndrome

- Lymphoblastic lymphoma

- Mycosis fungoides

- Sezary syndrome

- Primary cutaneous T-cell lymphomas

- Primary CNS lymphoma

- B-cell or T-cell prolymphocytic leukemia

5. Subjects with a peripheral neuropathy ≥ Grade 2.

6. Known malignancy other than study indication that is progressing or has required
treatment within the past three years.

7. Received live, attenuated vaccine within four weeks of first dose.

8. Known history of human immunodeficiency virus (HIV) infection. No HIV testing is
required unless mandated by local health authority.

9. Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc)
antigen.

10. Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of
viral load. If hepatitis C antibody test is positive, a confirmatory test should be
performed. If the test is negative, subject is eligible for this trial.

11. Concurrent administration of strong CYP3A modulators.

12. Is pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment.

13. Subjects on proton pump inhibitors (PPIs). The last dose of PPIs must be administered
seven days prior to administration of study drug. Antacids are acceptable when
administered in a staggered dosing manner with CFT7455.

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

Eligibility last updated 10/19/22. Questions regarding updates should be directed to the study team contact.

Drug
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The Effect of Semaglutide in Subjects with Non-cirrhotic, Non-alcoholic Steatohepatitis (Essence)

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) (ESSENCE)

Alina Allen
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304521-P01-RST
20-013372
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Inclusion Criteria:

  • Age above or equal to 18 years at the time of signing informed consent.
  • Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to screening visit (V1).
  • Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification7 based on a central pathologist evaluation of the baseline liver biopsy.
  • A histological NAS ≥ 4 with a score of 1 or more in both steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.


Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products. 2. Previous participation in this trial. Participation is defined as randomisation. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. Argentina, Belgium, Brazil and EU/EEC countries: See local requirements in Appendix 9 (Section 10.9). 4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 180 days before the screening visit (V1)* . Participation is defined as exposure to investigational medicinal product and includes any post-treatment follow up period. 5. Documented causes of chronic liver disease other than NAFLD.
  • Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
  • Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
  • Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
  • Presence or history of hepatocellular carcinoma at randomisation.
  • Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A).** In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
  • ALT > 5 times ULN at screening (V2A).
  • AST > 5 times ULN at screening (V2A).
  • Doubling of ALT or AST level between V1 and V2A deemed clinically significant in the opinion of the investigator.
  • Total bilirubin > 1.5 mg/dL at screening (V2A). Total bilirubin level > 1.5 mg/dL is allowed if conjugated bilirubin is within normal range.
  • Alkaline phosphatase levels > 2 x ULN at screening (V2A).
  • INR of prothrombin time ≥ 1.35 at screening (V2A).
  • MELD score > 12 points at screening (V2A).
  • eGFR < 30 mL/min/1.73 m^2 as defined according to the CKDEPI creatinine equation (KDIGO 2012)39 at screening (V2A).
  • HbA1c > 80 mmol/mol (9.5%) at screening (V2A).
  • Thrombocyte count less than 150,000 per microliter of blood (V2A), unless it reflects the patient's habitual thrombocytes level and there is no presence of portal hypertension in the opinion of the investigator.
  • For subjects with T2D: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening (V2A) and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examinations.
  • Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
  • Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
  • Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the patient’s weight, in the opinion of the investigator, are allowed.
  • Presence or history within the past 5 years prior to screening (V2A) of malignant neoplasms other than hepatocellular carcinoma. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
  • Presence of acute pancreatitis within the past 180 days prior to screening (V2A).
  • History or presence of chronic pancreatitis at screening (V2A).
  • History or presence of type 1 diabetes.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Any of the following: myocardial infarction, stroke, classification of heart failure New York Heart Association (NYHA) Class IV, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 90 days prior to the day of screening (V2A) and between screening and randomisation.
  • Unstable body weight defined as more than 5% self-reported change in body weight in the period from 90 days prior to the screening visit (V1). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, the body weight should be stable in the opinion of the investigator from time of biopsy until screening (V1).
  • Any condition which, in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
  • Any subject where a substantial weight loss in the investigator’s opinion might jeopardise subject’s safety.

* Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention (e.g., vaccine) or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening (V1).

**Dose is considered stable if the total daily dose has not changed within the time frame. Shifts between generic drugs and brand-names is allowed as long as the total daily dose is not changed.

Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug
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Development and Validation of a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma

A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma

Kathleen Yost
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304151-H01-RST
21-003059
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Inclusion Criteria:

  • Able to read and write English fluently.
  • Can sign consent for themselves.
  • Age 18 years or older.
  • Diagnosis of sporadic Vestibular Schwannoma (VS) (also called acoustic neuroma).


Exclusion Criteria:

  • Age less than 18 years old.
  • Diagnosis of VS secondary to neurofibromatosis type 2 (NF2).
  • Lack of capacity to consent.
  • Unable to read/write English fluently.
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PROSPECTIVE EVALUATION OF CHRONIC PANCREATITIS FOR EPIDEMIOLOGIC AND TRANSLATIONAL STUDIES (THE PROCEED STUDY) (PROCEED)

PROCEED

Santhi Swaroop Vege
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-304153-H01-RST
21-003038
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Inclusion Criteria
•All Groups:

  • All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes.
  • Meet one set of group-specific inclusion criteria listed below.
  • All participants must be ≥ 18 years old and ≤ 75 years at the time of enrollment.

Inclusion Criteria
•No Pancreas Disease Controls:

  • No personal history or symptoms of pancreatic disease.
  • No upper abdominal symptoms
  • *Participant will answer “No” and “None” to below questions to meet this criterion:
    • Have you had a stomach ache or pain more than SIX times in the past year?
    • □ YES            □ NO
  • How many times have you had a feeling of WANTING TO THROW UP (nausea) in the last year?
    • □ NONE        □ ANY
  • No family history of pancreatic disorders, celiac disease, cystic fibrosis.
  • No history of acute infectious or inflammatory conditions requiring medical treatment or evaluation in the preceding 6 months (per provider clinical judgment).
  • No history of cancer, except for non-melanoma skin cancers.
  • No known pregnancy at the time of enrollment.
  • No solid organ transplant or history of HIV/AIDS.
  • Able to provide an informed consent.
  • Not currently incarcerated.
  • ASA 1-2.

Inclusion Criteria - Chronic Upper Abdominal Pain of Suspected Pancreatic Origin:

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration for which a pancreatic origin is clinically considered in the differential diagnosis.*

* Pancreatic type pain is defined as epigastric pain that is often constant, often worsens post-prandially, and may radiate to the back. This can often be associated with lipase/amylase elevations that do not meet the threshold for diagnosis of AP (i.e. <3-fold upper limit of normal).

  • No history of AP or CP.
  • No prior endoscopic sphincterotomy or pancreatic surgery.
  • Normal cross-sectional abdominal imaging (CT and MRI/MRCP).**

** CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment as “Chronic Abdominal Pain – Undifferentiated”. The second imaging study can be performed in this situation after the enrollment and the final assignment into the appropriate subgroup can be done after review of the imaging results.

  • If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation and attempts will be made to complete this during follow-up as feasible. If the second study could not be performed, the subject will be assigned to Chronic upper abdominal pain group if the available study was normal or as Indeterminate CP if the available study shows Cambridge 1-2 findings.

Inclusion Criteria - Indeterminate CP with no history of AP:

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration for which a pancreatic origin is clinically considered in the differential diagnosis*

* Pancreatic type pain is defined as epigastric pain that is often constant, often worsens post-prandially, and may radiate to the back. This can often be associated with lipase/amylase elevations that do not meet the threshold for diagnosis of AP (i.e. <3-fold upper limit of normal).

  • No history of AP or CP.**

**AP is defined as compatible symptoms (upper abdominal pain) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR).

  • Cambridge grade I-II changes of CP# on cross-sectional imaging (CT or MRI/MRCP).***

*** CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment.  CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment as “Chronic Abdominal Pain – Undifferentiated”. The second imaging study can be performed in this situation after the enrollment and the final assignment into the appropriate subgroup can be done after review of the imaging results.

  • If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation and attempts will be made to complete this during follow-up as feasible. If the second study could not be performed by month 6 after enrollment, the subject will be assigned to Chronic upper abdominal pain group if the available study was normal or as Indeterminate CP if the available study shows Cambridge 1-2 findings. 
  • No prior endoscopic sphincterotomy or pancreatic surgery.

Inclusion Criteria - Acute Pancreatitis (AP):

  •  History of one documented attack of AP in the preceding 18 months.*

* AP is defined as compatible symptoms (upper abdominal pain) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR). Patient should not have had an attack of AP in the month prior to enrollment.

  • Patients should not have had an ERCP prior to the episode of AP.
  • Pancreatitis episode is not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
  • Pancreatic necrosis, if present, is <50% (to be verified by a CPDPC site radiologist).
  • Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP).***

*** CT and MRI/MRCP must be performed ≤ 24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study  can be performed in this situation after the enrollment.

  • If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation. Final group assignment in this situation will be based on the available study.   
  • No prior pancreatic surgery.

Inclusion Criteria - Recurrent Acute Pancreatitis (RAP):

  • Two or more documented attacks of AP* separated by at least 1 month, with complete symptom resolution between the attacks.

* AP is defined as compatible symptoms (epigastric pain with nausea or vomiting) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR).

  • Patient should not have had an ERCP prior to having first documented attack of pancreatitis.
  • Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP)**

**CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study can be performed in this situation after the enrollment.

  • Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP).**

**CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study can be performed in this situation after the enrollment.

  • If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation. Final assignment in this situation will be based on the available study.
  • In a rare circumstance, the last imaging patient had was >24 months prior to enrollment. In this circumstance, the patient is still eligible for enrollment, and can undergo CT scan first, and if there is no evidence of Cambridge 3-4 findings, undergo an MRI/MRCP to fulfill entry criteria. If the planned studies could not be completed within 6 months after enrollment, the final group assignment will be in this situation will be based on the available study.
  • Pancreatitis episodes are not attributable to gallstones, medications, trauma or autoimmune pancreatitis.
  • No prior pancreatic surgery.

Inclusion Criteria - Definite Chronic Pancreatitis

  • Presence of unequivocal CP (i.e., Cambridge grade ≥ 3) and/or parenchymal and/or ductal calcifications by cross-sectional imaging (IV contrast-enhanced MRI/MRCP or CT) verified by the CPDPC site radiologist.*

* Must exclude the possibility that calcifications are vascular. Calcifications noted by EUS only (and not correlated with CT) are not included as definite CP. A non-contrast CT scan or MRI/MRCP documenting definite CP as per criteria is acceptable for enrollment.

  • Pancreatic histology diagnostic of CP (including findings of fibrosis [Ammann’s ≥ 6], chronic inflammation, and acinar loss) as verified by a CPDPC site pathologist, if pathology slides are available for review.


Exclusion Criteria:

  • History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which   results in suspected disconnected duct syndrome.
  • Primary pancreatic tumors
    •pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 
  • Pancreatic metastasis from other malignancies.
  • History of solid organ transplant, HIV/AIDS.
  • Known isolated pancreatic exocrine insufficiency (e.g., in the absence of any eligible inclusion criteria).
  • Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator’s opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
  • Patients with known abnormal creatinine (GFR < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP (yellow) subgroups).
  • Failure to agree for longitudinal follow-up.
  • Known Pregnancy. All participants of childbearing potential, except if post-menopausal [i.e., no menses for ≥ 2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
  • Currently incarcerated.
  • Inability to get MRI/MRCP in patients with chronic abdominal pain of suspected pancreatic origin (Green II) or Suspected CP (Yellow groups) at baseline (e.g., metal object in the body which precludes performance of MRI).
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CHIlled Platelet Study (CHIPS)

CHIlled Platelet Study "CHIPS"

Allan Klompas
All
18 years to 84 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-304170-P01-RST
21-003137
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Inclusion Criteria:

  • Age greater than 28 days and less than 85 years.
  • Planned complex cardiac surgery with planned use of cardiopulmonary bypass.


Exclusion Criteria:

  • Expected order for washed or volume reduced platelets.
  • Patient with known anti-platelet antibodies.
  • Platelet transfusion refractoriness due to anti-HLA antibodies.
  • Known or suspected pregnancy.
  • Previously randomized in this study.
  • Conscious objection or unwillingness to receive blood products.
  • Known IgA deficiency.
  • Known congenital platelet disorder.
  • Known congenital bleeding disorder.
  • Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis.
  • Patients intended to receive whole blood either intra-operative or post-operative for bleeding.
  • Platelet transfusion (of any type) within 24 hours prior to receiving study platelets.
  • Pre-operative thrombocytopenia.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Image guidance navigation provides objective feedback that can be used to evaluate surgical trainees and consultants. (TruDi)

Image Guidance Navigation Provides Objective Feedback That Can Be Used to Evaluate Surgical Trainees and Consultants

Janalee Stokken
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304177-H01-RST
21-001245
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Inclusion Criteria:
 

  • Resident, fellow or teaching physicians participating and endoscopic sinus surgery for chronic rhinosinusitis.


Exclusion Criteria:
   

  • Anyone not meeting inclusion criteria or anyone not wishing to participate.
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Study Evaluating the Prevalence of the KIT D816V Mutation in Peripheral Blood of Patients with Evidence of Systemic Mast Cell Activation (MCA)

Study Evaluating the Prevalence of the KIT D816V Mutation in Peripheral Blood of Patients with Evidence of Systemic Mast Cell Activation (MCA)

Thanai Pongdee
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304189-P01-RST
21-003756
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Inclusion Criteria:

  • Written informed consent.
  • Age ≥ 18 years.
  • Presenting with at least one of the three criteria below as evidence of systemic MCA:
    • Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND sBT levels ≥ 8 ng/ml. One of the organ systems must be the cardiovascular system;
    • Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing, and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND sBT levels ≥ 8 ng/ml. One of the organ systems must be the cardiovascular system;
    • Severe anaphylaxis (Ring and Messmer grading ≥ II) due to Hymenoptera sting, regardless of sBT levels;
    • Severe anaphylaxis (Ring and Messmer grading ≥ II), with cardiovascular involvement and documented event-related tryptase elevation fitting the formula 20% of baseline plus 2 ng/ml evaluated in at least 1 event.


Exclusion Criteria:

  • Patient diagnosed with any of the following WHO SM sub-classifications:
    • Mastocytosis in the Skin (MIS; Adult CM);
    • Indolent Systemic Mastocytosis (ISM);
    • Smoldering Systemic Mastocytosis (SSM);
    • SM-Associated Hematologic Neoplasm (SM-AHN);
    • Aggressive Systemic Mastocytosis (ASM);
    • MC Leukemia (MCL);
    • MC Sarcoma (MCS).

Eligibility last updated 5/13/22. Questions regarding updates should be directed to the study team contact.

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Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated To Chemotherapy or Radiation, In Advanced Cancer Patients – A Confirmatory Phase III MNCCTN Trial

Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

Charles Loprinzi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304197-P01-RST
21-011317
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically-confirmed cancer in an advanced incurable stage.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale).
  • Serum creatinine < 2.0 mg/dl and SGOT (AST) or SGPT (ALT) values < 3 times upper limits of normal, ≤ 120 days prior to registration.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Able to provide written informed consent.
  • Able to complete questionnaire(s) by themselves or with assistance.

Registration


Exclusion Criteria:

Any of the following because this study involves:

  • An agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant persons;
    • Nursing persons.
  • Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible).
  • Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for ≤ 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy).           
  • Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection (including HIV);
    • cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient;
    • psychiatric illness/social situations that would limit compliance with study requirements.
  • Inability to swallow oral formulations of the agent(s).
  • Tube feeding or nasogastric tube.

Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Other
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A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids

A Study to Evaluate Obinutuzumab to Treat Immunosuppression-dependent or Immunosuppression/Treatment-resistant Focal Segmental Glomerulosclerosis

Fernando Fervenza
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304199-H01-RST
21-003887
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Biopsy proven Focal Segmental Glomerulosclerosis (FSGS) lesion
  • Foot process effacement ≥ 80% on electron microscopy.
  • Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy.
  • Resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. Patient who have contraindication to or refuse to take high dose corticosteroids are allowed. 


Exclusion Criteria:

  • Genetic or secondary forms of FSGS.
  • Hepatitis B, C or HIV positive.
  • Pregnant or breast-feeding.
  • Active infection.
  • Kidney transplant.
  • Anemia with Hgb < 8.0 g/dL.
  • Thrombocytopenia with platelet count < 100’000.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
  • Patients who have received cyclophosphamide in the last 6 months.
  • Patients who received rituximab previously with CD20 count of < 5 cells/microliter  at the time of enrollment.
  • For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug.
  • For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug.
Biologic/Vaccine
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A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE) (ATMOSPHERE)

A Study to Evaluate Gene Therapy to Treat Neovascular Age-related Macular Degeneration

Sophie Bakri
All
50 years to 89 years old
Phase 2/3
This study is NOT accepting healthy volunteers
2021-304212-P01-RST
21-003698
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Inclusion Criteria:

  • Males or females, aged ≥ 50 years and ≤ 89 years.
  • An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye at Screening Visit 1.
  • If both eyes are eligible, the study eye must be the participant’s worse-seeing eye, as determined by the investigator prior to randomization.
  • Must have a diagnosis of subfoveal CNV secondary to AMD in the study eye, along with fluid within the parafovea (3-mm center of the macula, based on the early treatment diabetic retinopathy grid) at Screening Visit 1.
    • CNV lesion characteristics as assessed by the CRC: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm^2).
  • Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
  • Must be willing and able to comply with all study procedures and be available for the duration of the study.
  • Women must be postmenopausal (defined as being at least 12 consecutive months without menses) or surgically sterilized (ie, having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy).
  • Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use condoms (and their partners to use a medically accepted method of contraception) from the day of RGX-314 administration until 4 weeks after RGX-314 administration.
  • Must be willing and able to provide written, signed informed consent.
  • Response criteria: Based on the Screening Visit 2 SD-OCT, participants must have improvement in fluid of > 50 μm or, if the participant has < 50 μm of fluid, then any improvement in fluid and have a CRT < 400 μm at the screening visit, as determined by the CRC. Note that, if the participant has disease other than fluid contributing to an increase (i.e., pigment epithelial detachment [PED] or subretinal hyper-reflective material [SHRM]) in CRT, they will be enrolled if they have < 50 μm of fluid (intraretinal or subretinal), as determined by the CRC.
  • Additionally, participants who received 10 to 12 anti-VEGF injections in the study eye in the 12 months prior to Screening Visit 1 must demonstrate a complete fluid response as determined by CRC review of the Screening Visit 2 SD-OCT, defined as complete resolution of fluid.


Exclusion Criteria:

  • CNV or macular edema in the study eye secondary to any causes other than AMD.
  • Subfoveal fibrosis or atrophy as determined by the CRC.
  • Study eye that required > 12 anti-VEGF injections in the 12 months prior to the Screening Visit
  • Any condition in the investigator’s opinion that could limit VA improvement in the study eye.
  • Active or history of retinal detachment in the study eye.
  • Advanced glaucoma in the study eye defined as IOP of > 23 mmHg not controlled by 2 IOP-lowering medications or any invasive procedure to treat glaucoma (e.g., shunt, tube, or minimally invasive glaucoma surgery [MIGS] devices; selective laser trabeculectomy, and argon laser trabeculoplasty are permitted).
  • Study eye with nAMD diagnosed > 4 years from Screening Visit 1.
  • Any condition in the study eye that, in the opinion of the investigator, may increase the risk to the participant, require either medical or surgical intervention during the course of the study to prevent or treat vision loss, or interfere with study procedures or assessments.
  • History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1. Yttrium aluminum garnet capsulotomy is permitted if performed > 10 weeks prior to the Screening Visit 1.
  • History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
  • Presence of any implant in the study eye at Screening Visit 1 (excluding intraocular lens or MIGS).
  • History of malignancy or hematologic malignancy that may compromise the immune system requiring chemotherapy and/or radiation in the 5 years prior to Screening Visit 1. Localized basal cell carcinoma will be permitted.
  • Receipt of any investigational product within the 30 days of enrollment or 5 half-lives of the investigational product, whichever is longer.
  • Received gene therapy.
  • History of retinal toxicity caused by a therapy that may affect VA, eg, chloroquine or hydroxychloroquine.
  • Ocular or periocular infection in the study eye that may interfere with the surgical procedure.
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.
  • Any participant with the following laboratory values at Screening Visit 1 will be withdrawn from study:
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN);
    • Total bilirubin > 1.5 × ULN, unless the participant has a previously known history of Gilbert’s syndrome and a fractionated bilirubin that shows conjugated bilirubin < 35% of total bilirubin;
    • Prothrombin time > 1.5 × ULN, unless the participant is anticoagulated:
      • Participants who are anticoagulated will be monitored by local labs and managed per local practice to hold or bridge anticoagulant therapy for the study procedure; consultation with the Medical Monitor is also required;
    • Hemoglobin < 10 g/dL for male participants and < 9 g/dL for female participants;
    • Platelets < 100 × 10^3/μL;
    • Estimated glomerular filtration rate < 30 mL/min/1.73 m^2.
  • Currently taking anticoagulation therapy for which holding anticoagulation therapy for RGX-314 administration is not indicated or considered to be unsafe in the opinion of the treating investigator (i.e., retinal surgeon), as well as the physician prescribing anticoagulation for the participant.
  • Any concomitant treatment that, in the opinion of the investigator, may interfere with ocular surgical procedure or healing process.
  • Known hypersensitivity to ranibizumab or any of its components.
  • Has a serious, chronic, or unstable medical or psychological condition that, in the opinion of the investigator or Sponsor, may compromise the participant’s safety or ability to complete all assessments and follow-up in the study.
  • Prior corneal transplant in the study eye.
  • Pigmentary glaucoma in the study eye.

Inclusion Criteria for Participants in the Control Arm Who Cross Over to RGX-314 Treatment After Week 54:

  • Study eye will be the eye that qualified at randomization.
  • Study eye has a CRT < 400 μm of fluid or (in cases where a participant may have nonfluid elevation in the CRT, eg, pigment epithelial defect) < 50 μm of excess fluid, as confirmed by the masked CRC.
  • Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use condoms (and their partners to use a medically accepted method of contraception) from the day of RGX-314 administration until 4 weeks after RGX-314 administration.


Exclusion Criteria:

  • CNV or macular edema in the study eye secondary to any causes other than AMD.
  • New subfoveal fibrosis or atrophy since randomization, as determined by the CRC, or any condition preventing VA improvement in the study eye.
  • Ocular or periocular infection in the study eye that may interfere with the surgical procedure.
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attacks since randomization.
  • Uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.
  • Any concomitant treatment that, in the opinion of the investigator, may interfere with ocular surgical procedure or healing process.
  • History of malignancy or hematologic malignancy that may compromise the immune system requiring chemotherapy and/or radiation since randomization. Localized basal cell carcinoma will be permitted.
  • Currently taking anticoagulation therapy for which holding anticoagulation therapy for RGX-314 administration is not indicated or considered to be unsafe in the opinion of the treating investigator as well as the physician prescribing anticoagulation for the participant.

Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Genetic
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A021804; A Prospective, Multi-institutional Phase II Trial Evaluating Temozolomide vs Temozolomide vs. and Olaparib for Advanced Pheochromocytoma and Paraganglioma

A Study Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma

Mabel Ryder
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304222-P01-RST
21-003973
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​​​​​​

Inclusion Criteria:

  • Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 1 cm with CT or MRI (or ≥ 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly nonmeasurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.
  • Prior treatment with other chemotherapy, radiotherapy (including peptide radionuclide receptor therapy [PRRT]), or surgery must be completed ≥ 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration. Prior treatment with radiolabeled MIBG must be completed ≥ 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be < 1000 MBq kg-1 (36 mCi kg-1 ). Prior treatment with antibiotics must be completed ≥ 7 days prior to registration. No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor. No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
  • Therapy utilized in this trial is associated with medium/high fetal risk. Women of childbearing potential and their partners, who are sexually active, must agree to use two highly effective forms of contraception in combination. This should be started from the time of registration and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse. Male patients must use a condom during treatment and for 3 months after the last dose of study drug(s) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.
  • Male patients should not donate sperm throughout the period of taking study drug(s) and for 3 months following the last dose of study drug(s).
  • Age ≥ 18 years old.
  • ECOG Performance Status: 0-2.
  • Required Initial Laboratory Values:
    • Absolute Neutrophil Count ≥ 1,500/mm^3;
    • Platelet Count ≥ 100,000/mm3;
    • Hemoglobin ≥ 10 mg/dL* ;
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)** ;
    • AST/ALT ≤ 3.0 x ULN;
    • Creatinine < 1.5 x ULN OR Calc. Creatinine Clearance > 50 mL/min.***

*.   In the absence of transfusion within the previous 24 hours.
**   Except in the case of Gilbert’s syndrome, then Total Bilirubin must be ≤ 3.0 x ULN.
*** Calculated by Cockcroft-Gault equation.


Exclusion Criteria:

  • No indication of uncontrolled, potentially reversible cardiac condition(s) as determined by investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 msec, electrolyte disturbances, etc.) and no known congenital long QT syndrome.
  • No extensive bilateral lung disease or pneumonitis.
  • No abnormal organ or bone marrow function ≤ 28 days prior to registration.
  • Patients with HIV positivity are allowed if CD4 Count > 250 cells/μL and they have an undetectable HIV viral load within 6 months of registration.
  • No active infection.
  • No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia.
  • No known gastrointestinal condition(s) that might predispose for drug intolerability or poor drug absorption.
  • No known medical condition causing an inability to swallow oral formulations of agents.
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PARP inhibitors.
  • Concurrent use of combination antiretroviral therapy (ART) is not permitted.
  • Chronic concomitant treatment with strong or moderate CYP3A4 inducers or inhibitors is not allowed.
  • Patients must discontinue the agent(s) ≥ 21 days prior to registration; enzalutamide and/or phenobarbital must be discontinued ≥ 5 weeks prior to registration. 

 

    Drug, Other
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    Mayo Clinic — Rochester, MN

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (“APS ACTION”) International Clinical Database and Repository (APS ACTION)

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION)

    Ali Duarte Garcia
    All
    18 years to 75 years old
    This study is NOT accepting healthy volunteers
    2021-304223-P01-RST
    20-006195
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    Inclusion Criteria:

    • Age 18-75.
    • Persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to the screening defined as: o aCL IgG/M/A (> 40U, medium-to-high titer, and/or greater than the 99th percentile) and/or o aβ2GPI IgG/M/A (>40U, medium-to-high titer, and/or greater than the 99th percentile) and/or o Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations.


    Exclusion Criteria:

    • Patient refusal.
    • Inability to comply with study and follow-up procedures.
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    Mayo Clinic — Rochester, MN

    EMPOWER: Endometriosis Diagnosis Using MicroRNA: PrOspective study in Women to Allow Early Disease Recognition (EMPOWER)

    EMPOWER: Endometriosis Diagnosis Using microRNA

    Tatnai Burnett
    Female
    18 years to 49 years old
    This study is NOT accepting healthy volunteers
    2021-305943-P01-RST
    21-009830
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    Inclusion Criteria:

    • Subject is willing and able to provide written informed consent.
    • Subject is willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures.
    • Subject is a female aged 18 through 49 years (inclusive).
    • Subject is scheduled to undergo either:
      • Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis;
      • Laparotomy, laparoscopy, or other procedures including, but not limited to, tubal ligation, lysis of adhesions, hysterectomy for benign condition, myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy for indications including, but not limited to, infertility or benign gynecological indications. 

    Exclusion Criteria:

    • Subject has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
    • Subject is a female in a pre-menarchal or post-menopausal state or has been rendered surgically menopausal (bilateral oophorectomy) for at least 6 months at Screening.
    • Subject is pregnant.
    • Subject has an active malignancy.
    • Subject is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
    • Subject has an active pelvic infection or other infections contraindicated for surgery.
    • Subject has participated (+/-3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
    • Subject is undergoing or has previously undergone masculinizing hormone therapy (testosterone treatment).
    • Subject has any general health or behavioral condition that, in the opinion of the investigator, should exclude the subject from participation.

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

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    Mayo Clinic — Rochester, MN

    NRG-BR007, A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    Ron Smith
    All
    50 years to 70 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-305950-P01-MAIJ
    21-009845
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    Inclusion Criteria:

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
    • The patient must have an ECOG performance status of 0 or 1.
    • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection).
    • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
    • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
    • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
      • By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm);
      • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible);
      • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen;
        • ** For patients with a T1a tumor (less than or equal to 0.5 cm in size) who do not already have an Oncotype DX Recurrence Score at study entry, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory.
      • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive;
      • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
    • Patients may be premenopausal or postmenopausal at the time of study entry. For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or a documented hysterectomy; or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or documented bilateral oophorectomy.
    • The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
    • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
    • Bilateral mammogram or MRI within 6 months prior to study entry. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
    • Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.


    Exclusion Criteria:

    • Definitive clinical or radiologic evidence of metastatic disease. -pT2
      •pT4 tumors including inflammatory breast cancer.
    • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
    • Patient had a mastectomy.
    • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
    • Non-epithelial breast malignancies such as sarcoma or lymphoma.
    • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible).
    • Paget's disease of the nipple.
    • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible).
    • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible).
    • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible).
    • Treatment plan that includes regional nodal irradiation.
    • Any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy administered for the currently diagnosed breast cancer prior to study entry. (Short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
    • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Short course endocrine therapy of < 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible.
    • Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
    • Prior breast or thoracic RT for any condition.
    • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
    • Pregnancy or lactation at the time of study entry or intention to become pregnant during treatment.
      • Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study entry.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
    • Use of any investigational product within 30 days prior to study entry.

    Eligibility last updated 9/20/21. Questions regarding updates should be directed to the study team contact.

    Other, Drug
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    Mayo Clinic Health System — Mankato, MN

    NRG-BR007, A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    Timothy Kozelsky
    All
    50 years to 70 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-305950-P01-ALCL
    21-009845
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    Inclusion Criteria:

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
    • The patient must have an ECOG performance status of 0 or 1.
    • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection).
    • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
    • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
    • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
      • By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm);
      • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible);
      • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen;
        • ** For patients with a T1a tumor (less than or equal to 0.5 cm in size) who do not already have an Oncotype DX Recurrence Score at study entry, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory.
      • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive;
      • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
    • Patients may be premenopausal or postmenopausal at the time of study entry. For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or a documented hysterectomy; or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or documented bilateral oophorectomy.
    • The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
    • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
    • Bilateral mammogram or MRI within 6 months prior to study entry. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
    • Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.


    Exclusion Criteria:

    • Definitive clinical or radiologic evidence of metastatic disease. -pT2
      •pT4 tumors including inflammatory breast cancer.
    • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
    • Patient had a mastectomy.
    • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
    • Non-epithelial breast malignancies such as sarcoma or lymphoma.
    • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible).
    • Paget's disease of the nipple.
    • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible).
    • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible).
    • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible).
    • Treatment plan that includes regional nodal irradiation.
    • Any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy administered for the currently diagnosed breast cancer prior to study entry. (Short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
    • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Short course endocrine therapy of < 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible.
    • Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
    • Prior breast or thoracic RT for any condition.
    • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
    • Pregnancy or lactation at the time of study entry or intention to become pregnant during treatment.
      • Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study entry.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
    • Use of any investigational product within 30 days prior to study entry.

    Eligibility last updated 9/20/21. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic Health System — Albert Lea, MN

    NRG-BR007, A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

    Dean Shumway
    All
    50 years to 70 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-305950-P01-RST
    21-009845
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    Inclusion Criteria:

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
    • The patient must have an ECOG performance status of 0 or 1.
    • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection).
    • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
    • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
    • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
      • By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm);
      • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible);
      • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen;
        • ** For patients with a T1a tumor (less than or equal to 0.5 cm in size) who do not already have an Oncotype DX Recurrence Score at study entry, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory.
      • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive;
      • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
    • Patients may be premenopausal or postmenopausal at the time of study entry. For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or a documented hysterectomy; or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or documented bilateral oophorectomy.
    • The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
    • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
    • Bilateral mammogram or MRI within 6 months prior to study entry. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
    • Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.


    Exclusion Criteria:

    • Definitive clinical or radiologic evidence of metastatic disease. -pT2
      •pT4 tumors including inflammatory breast cancer.
    • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
    • Patient had a mastectomy.
    • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
    • Non-epithelial breast malignancies such as sarcoma or lymphoma.
    • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible).
    • Paget's disease of the nipple.
    • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible).
    • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible).
    • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible).
    • Treatment plan that includes regional nodal irradiation.
    • Any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy administered for the currently diagnosed breast cancer prior to study entry. (Short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
    • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Short course endocrine therapy of < 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
    • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible.
    • Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
    • Prior breast or thoracic RT for any condition.
    • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
    • Pregnancy or lactation at the time of study entry or intention to become pregnant during treatment.
      • Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study entry.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
    • Use of any investigational product within 30 days prior to study entry.

    Eligibility last updated 9/20/21. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Bladder Bank (Bladder Bank)

    Bladder Bank

    John Kisiel
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305962-H01-RST
    21-009854
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    Inclusion Criteria:
      

    • Age ≥ 18 years.
    • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy).


    Exclusion Criteria:
      

    • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
    • Patient has recurrent bladder cancer.
    • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
    • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
    • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
    • Patient has had any prior radiation therapy to the target lesion prior to current collection.
    • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
    • Patient has undergone cystectomy.
    • Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection.
    • Patient has had a urinary tract infection within 14 days prior to urine collection.
    • Patient has chronic indwelling urinary catheter 
    • Patient has prior diagnosis of bladder cancer for which prior resection of tumor was performed.

    Eligibility last updated 6/29/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Immune Checkpoint Inhibition and Humoral Immune Response in Systemic Autoimmunity (ICIRA)

    ICI and Response in Autoimmunity

    Hu Zeng
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305966-H01-RST
    21-009862
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    Inclusion Criteria:

    • Adults, age ≥ 18 years.
    • Any concomitant malignancy being treated with any PD-1 inhibitor (pembrolizumab, nivolumab or cemiplimab) as monotherapy and the presence of inflammatory arthritis defined by:
      • provider documented inflammatory arthritis (meet 2010 EULAR/ACR classification criteria of RA) in one or more large or small joints; and at least one or more of the following:
      • elevated inflammatory markers;
      • supportive imaging and/or supportive synovial fluid analysis.


    Exclusion Criteria:

    • Active infection.
    • Prior history of the rheumatic disease.
    • Any B cell depletion therapy.
    • PActive use of high (≥ 30 mg daily) of prednisone or steroid equivalent.
    • Clinical features suggestive of non-RA autoimmune rheumatic disease (e.g., lupus, Sjogren’s, psoriatic arthritis, etc.) or axial spondyloarthropathy.

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

     

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    Mayo Clinic — Rochester, MN

    A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial) (TRIUMPH)

    Tadalafil vs. Placebo to Improve Hemodynamics and End-Organ Dysfunction in Fontan Physiology

    Alexander Egbe
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-305977-H01-RST
    21-009890
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    Inclusion Criteria:


    - Patients ≥ 18 years old.

    - Have previously undergone a Fontan Palliation.

    - Able to exercise using a supine bike.

    - Able to undergo an MRI.

    - Ability and willingness to provide written consent.

    - Undergoing a clinically indicated Cardiac Catheterization


    Exclusion Criteria:


    - Patients < 18 years old.

    - Current intravenous inotropic drugs.

    - Current use of alpha-blockers, pulmonary vasodilators, or nitrates.

    - Unable to exercise.

    - Pregnancy or lactating.

    - Unable or unwilling to consent.

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

    Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    ORIC-533-01, An Open-label Phase 1b Study of ORIC-533 in Patients With Relapsed or Refractory Multiple Myeloma (ORIC-533-01)

    Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma

    Wilson Gonsalves
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-305995-P01-RST
    21-010004
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    Inclusion Criteria:
    -Diagnosis of multiple myeloma (MM) with relapsed or refractory disease according to IMWG Criteria -Refractory to or not eligible for MM treatment regimens known to provide clinical benefit, including but not limited to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with documented disease progression -Measurable disease at screening, including at least 1 of the criteria below: -Serum M-protein >0.5 g/dL (Patients with IgA myeloma in whom serum M protein is unreliable due to comigration of normal serum proteins may be considered eligible if total IgA >400 mg/dL) -Urine M-protein >200 mg/24 hours -Serum free light chains (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65) -Measurable bone or extramedullary plasmacytoma -ECOG performance status ≤2 -Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: -Estimated glomerular filtration rate ≥60 mL/min/1.73 m2. -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal, unless there is suspected disease in the liver, in which case, no limit is set provided serum bilirubin is within eligibility criterion -Total bilirubin <1.5 × upper limit of normal (ULN), except in study participants with Gilbert's syndrome -Platelet count >50,000/μL -Absolute neutrophil count (ANC) >1000/μL -Left ventricular ejection fraction (LVEF) >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) -Baseline oxygen saturation >92% on room air
    Exclusion Criteria:
    -Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy -Previous or concurrent plasma cell leukemia, AL amyloidosis, or POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome -Known central nervous system (CNS) involvement -Evidence of hyperviscosity syndrome -Receiving any investigational treatment with a novel investigational agent (ie, no approved indication) within 28 days prior to the first dose of study drug -Not recovered or stabilized from all toxicities from prior anticancer therapies and/or radiotherapy to Grade <2 with the exception of peripheral neuropathy -Major surgery or radiation therapy within 14 days prior to first dose of study drug or incomplete recovery from adverse effects resulting from such procedure -Those who require limited course of radiation for management of bone pain for ≤14 days from initiation of therapy are not excluded -Infection requiring systemic antibiotic therapy or other serious infection within 14 days of starting therapy -Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection, are eligible -Daily requirement for corticosteroids (equivalent to >10 mg/day prednisone). Inhalation corticosteroids are exempt from this criterion -Exception: Corticosteroid dose equivalent >10 mg/day prednisone is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy -Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy are also acceptable -Known seropositive for active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded. -History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of first dose of study drug -QTcF >470 msec -Other concurrent serious uncontrolled medical, psychological, or addictive conditions that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study
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    Mayo Clinic — Rochester, MN

    Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study (CORAL)

    Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients, CORAL Study

    John Kisiel
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-305999-P01-RST
    21-010010
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    Inclusion Criteria:

    • Patients at least 18 years of age.
    • Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset CRC (< 50 years old).
    • Colonoscopy scheduled +/- 90 days.


    Exclusion Criteria:
     

    • Individuals who have not agreed to participate and have not signed the study consent form.
    • Patient has known cancer (Stage I-IV) 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is still eligible).
    • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection.
    • Patient has had any abdominal radiation therapy prior to current sample collection.
    • Patient had therapy to the target lesion with intent to completely remove or debulk the lesion prior to sample collection (examples include polypectomy, EMR, ESD, surgical resection, trans anal excision).

    Additional Stool Exclusions:

    • Bowel prep < 7 days prior to stool collection.
    • Oral or rectal contrast given within 7 days prior to stool collection.
    • Removal of more than 50% of colon or presence of ileostomy.
    • Enteral feeds or TPN.
    • Diagnosis of inflammatory bowel disease.

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

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    Mayo Clinic — Rochester, MN

    ALKS 4230-006, A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6 (ARTISTRY-6)

    Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma

    Matthew Block
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-306026-P01-RST
    21-010085
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    Inclusion Criteria:

    • Patient is ≥ 18 years of age.
    • Patient or patient’s legal representative is willing and able to provide written informed consent.
    • Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
    • The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2).
    • Patient must have received previous treatment as follows:
      • patient has received anti-PD-[L]1 therapy ± anti-CTLA-4 therapy, and ≤ 1 other prior regimen of systemic anti-neoplastic therapy;
      • patient should have experienced objective response (PR or CR) or SD as BOR to anti-PD-[L]1 therapy;
      • patients with BRAF mutations may or may not have received prior targeted therapy.
    • A patient who has received prior treatment with talimogene laherparepvec (TVEC) is allowed to enroll provided that last exposure to TVEC was ≥ 28 days prior to first exposure to nemvaleukin and that all injection-site reactions to TVEC have resolved. TVEC shall not be considered a prior regimen of systemic anti-neoplastic therapy, nor shall it be considered a systemic immunomodulatory agent.
    • Patient has at least one measurable lesion that qualifies as a target lesion based on RECIST 1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
    • Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue. To qualify, archival tissue must have been sampled after last exposure to any systemic anti-neoplastic agent (including TVEC). Patients unable to undergo a biopsy may be enrolled if risk/benefit ratio of biopsy is considered unfavorable and/or when a biopsy would likely lead to significant delays in care. This decision must be accompanied by supporting documentation from the Investigator and performed in consultation with Medical Monitor. All pretreatment tissue must have been collected no more than 120 days prior to screening.
    • Patient has recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and/or surgery (i.e., residual toxicity no worse than Grade 1 [Grade 2 treatment-associated peripheral neuropathy and/or any grade of alopecia are acceptable assuming all other inclusion criteria are met]).
    • Patient who has received prior systemic anti-neoplastic agent(s) must wait at least 5 half-lives or 4 weeks (whichever is shorter) following prior therapy before enrollment into the study, or 4 weeks if the half-life of a given investigational agent is not known.
    • Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 5 days before the first dose of study drug and an estimated life expectancy of at least 3 months.
    • Patient has adequate hematologic reserve as evidenced by:
      • Absolute neutrophil count (ANC) of ≥ 1000/µL;
      • Absolute lymphocyte count of ≥ 500/µL;
      • Platelet count of ≥ 75,000/µL; and
      • Hemoglobin of ≥ 9 g/dL (patients may be transfused to this level if necessary, but transfusion must occur > 1 week prior to the first dose of study drug).
    • Patient has adequate hepatic function as evidenced by aspartate transaminase and alanine transaminase values ≤ 3 × the upper limit of normal (ULN) and serum total bilirubin values of ≤ 1.5 × ULN (≤ 2 × ULN for patients with known Gilbert’s syndrome) for the reference laboratory measured within 7 days prior to the first dose of study drug. For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase and 2 × ULN for bilirubin.
    • Patient has adequate renal function as evidenced by a serum creatinine ≤ 1.5 × the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 45 mL/min by the Cockcroft-Gault Equation measured within 7 days prior to the first dose of study drug.
    • Patient has international normalized ratio (INR) AND/OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case INR and/or PT and aPTT must be within the desired therapeutic range of intended use for such anticoagulants.
    • Patient agrees to abide by the contraceptive requirements detailed in the protocol.
    • Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine) within 3 days before the first dose of study drug (see the protocol for the definition of WOCBP).


    Exclusion Criteria:

    • Patient has uveal melanoma.
    • Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
    • Patient has received radiotherapy within the last 4 weeks before start of study treatment, with the exception of limited field palliative radiotherapy to an area not inclusive of or adjacent to the target lesion(s), that has been completed at least 2 weeks before starting study treatment with no ongoing acute sequelae (eg, radiation burns).
    • Patient requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent) or patient has taken systemic corticosteroids (> 10 mg of prednisone daily, or equivalent) within 14 days prior to the first dose of study drug; however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
    • Patient has taken non-steroid systemic immunomodulatory agents (e.g., Enbrel®, Humira®, etc) within 28 days prior to the first dose of study drug or anticipates use of these therapies during the study period.
    • Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.
    • Patient has received a live or live-attenuated vaccine(s) within 30 days prior to the first dose of study treatment.
      • Note: COVID-19 vaccine is allowed.
    • Patient has received more than 3 doses of therapeutic systemic broad-spectrum antibiotics within 14 days prior to the first dose of study drug. Antibiotics given for peri-procedural prophylaxis or given presumptively for a limited time (eg, until infection was ruled out), as well as topical or intra-ocular antibiotics, shall not be exclusionary.
    • Patient has had any active infection and/or a fever ≥ 38.5°C (≥ 101°F) within 3 days prior to the first dose of study drug.
    • Patient has active autoimmune disease(s) requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that has required chronic or frequent systemic steroids. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
    • Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions or other lung disorders (eg, pulmonary embolism) with a baseline room air oxygen saturation of < 92% at screening, and/or dyspnea (≥ Grade 3), which requires oxygen therapy.
    • Patient has any other concurrent uncontrolled illness, including mental illness or substance use, which may interfere with the ability of the patient to cooperate and participate in the study. Other examples of such conditions would include unstable, poorly controlled, or severe hypertension; clinically significant pericardial effusion; New York Heart Association Class III or Class IV congestive heart failure; high risk cardiovascular disease, defined as unstable angina, myocardial infarction, or cerebrovascular accident within 6 months of first dose; uncontrolled diabetes mellitus that has required 2 or more hospitalizations in the last year and/or emergent management within the last 6 months; severe peripheral vascular disease; or recent serious trauma.
    • Patient has had an active second malignancy within the previous 2 years. This criterion does not apply to patients with adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, prostate cancer of highest Gleason score ≤ 6 with undetectable prostate-specific antigen over the previous 12 months, urothelial carcinoma in situ, or ductal carcinoma in situ of the breast that has undergone full surgical resection.
    • Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to begin breastfeeding during the study period or within 30 days after last study drug administration.
    • Patient has active or symptomatic central nervous system metastases unless all the following have been met: such metastases have been treated by surgery and/or radiation therapy, and/or gamma knife and have remained radiographically stable (or shrinking) on 2 consecutive imaging examinations performed at least 6 weeks apart; AND steroids have been tapered to a dose of 10 mg of prednisone (or equivalent) or less for at least 2 weeks prior to first dose of study agent(s); AND the patient is neurologically stable. Patients with history of brain metastases or a suspicion of brain metastases must have a brain magnetic resonance imaging (MRI) at baseline (Screening Visit).
    • Patient has known or suspected hypersensitivity to any components of nemvaleukin.
    • Patient has active uncontrolled coagulopathy.
    • Patient has QT interval corrected by the Fridericia Correction Formula values of > 470 msec (in females) or > 450 msec (in males); patient who is known to have congenital prolonged QT syndromes; or patient who is on medications known to cause prolonged QT interval on ECG.
    • Patient is known to be positive for human immunodeficiency virus. Patients with known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) are excluded; however, a patient with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) may be enrolled provided that HBV DNA is negative. Patients with known active hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] are detected) are excluded, however, a patient with cured hepatitis C (negative HCV RNA status) may be enrolled.
    • Patient has active or latent tuberculosis. Patients with cured tuberculosis may be enrolled.
    • Patient has developed Grade ≥ 3 immune-related adverse events (irAEs) while on prior immunotherapy (e.g., pneumonitis, nephritis, and neuropathy). Patients who have immunerelated endocrinopathies and are stable on hormone replacement therapy are not excluded. Patients who experienced colitis as a toxicity of prior immunotherapy must have undergone colonoscopy since last symptoms of colitis that confirms the absence of ongoing inflammation. Vitiligo is not exclusionary.

    Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.

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    A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sezary Syndrome (SS)

    Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome

    Nabila Bennani
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-306031-P01-RST
    21-010079
    Show full eligibility criteria
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    Inclusion Criteria:


    - Patients must have histologically or cytologically confirmed MF or SS, stages IIB to
    IVB with measurable disease and/or detectable blood involvement based on the Global
    Cutaneous Lymphoma Response Criteria

    - Patients must have had at least one line of prior systemic therapy

    - Age >= 18 years. Because no dosing or adverse event data are currently available on
    the use of duvelisib in combination with nivolumab in patients < 18 years of age,
    children are excluded from this study

    - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)

    - Absolute neutrophil count >= 1000/mcL

    - Platelets > 75,000/mcL

    - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 5 x
    institutional ULN if with history of Gilbert's syndrome

    - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
    [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
    =< 3 x institutional ULN

    - Creatinine =< 2.0 x institutional ULN

    - Patients with treated brain metastases are eligible if follow-up brain imaging after
    central nervous system (CNS)-directed therapy shows no evidence of progression

    - 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

    - The effects of nivolumab and duvelisib on the developing human fetus are unknown. For
    this reason and because other therapeutic agents used in this trial are known to be
    teratogenic, women of child-bearing potential (WOCBP) and men must agree to use
    adequate contraception (hormonal or barrier method of birth control; abstinence) prior
    to study entry and for the duration of study participation. WOCBP should use an
    adequate method to avoid pregnancy for 5 months after the last dose of investigational
    drug. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25
    IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to
    the start of nivolumab. Women must not be breastfeeding. Men who are sexually active
    with WOCBP must use any contraceptive method with a failure rate of less than 1% per
    year. Men receiving nivolumab and duvelisib and who are sexually active with WOCBP
    will be instructed to adhere to contraception for a period of 7 months after the last
    dose of investigational product. Women who are not of childbearing potential (i.e.,
    who are postmenopausal or surgically sterile as well as azoospermic men) do not
    require contraception. WOCBP is defined as any female who has experienced menarche and
    who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy)
    or who is not postmenopausal. Menopause is defined clinically as 12 months of
    amenorrhea in a woman over 45 in the absence of other biological or physiological
    causes. In addition, women under the age of 55 must have a documented serum follicle
    stimulating hormone (FSH) level less than 40 mIU/mL

    - Should a woman become pregnant or suspect she is pregnant while she or her partner is
    participating in this study, she should inform her treating physician immediately. Men
    treated or enrolled on this protocol must also agree to use adequate contraception
    prior to the study, for the duration of study participation, and 7 months after
    completion of administration of investigational agents on this study

    - Ability to understand and the willingness to sign a written informed consent document.
    Participants with impaired decision-making capacity (IDMC) who have a
    legally-authorized representative (LAR) and/or family member available will also be
    eligible

    - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
    therapy with undetectable viral load within 6 months are eligible for this trial


    Exclusion Criteria:


    - Prior therapy with a PI3K inhibitor

    - Prior therapy with nivolumab or other agents targeting T-cell co-stimulation or
    checkpoint pathways

    - Patients with active autoimmune disease or history of autoimmune disease that might
    recur, which may affect vital organ function or require immune suppressive treatment
    including systemic corticosteroids, should be excluded. 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, hepatitis; and patients with a history of toxic epidermal
    necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be
    excluded because of the risk of recurrence or exacerbation of disease. Patients with
    vitiligo, endocrine deficiencies including thyroiditis managed with replacement
    hormones including physiologic corticosteroids are eligible. Patients with rheumatoid
    arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with
    topical medication and patients with positive serology, such as antinuclear antibodies
    (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ
    involvement and potential need for systemic treatment but should otherwise be eligible

    - Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus,
    residual hypothyroidism due to autoimmune condition only requiring hormone
    replacement, psoriasis not requiring systemic treatment, or conditions not expected to
    recur in the absence of an external trigger (precipitating event)

    - Patients should be excluded if they have a condition requiring systemic treatment with
    either corticosteroids (> 10 mg daily prednisone equivalents) or other
    immunosuppressive medications within 7 days of study drug administration. Inhaled or
    topical steroids, steroids for physiologic or 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). 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

    - History of tuberculosis treatment within the 2 years prior to enrollment

    - Ongoing treatment with other immunosuppressive agent including, but not limited to,
    methotrexate, azathioprine, anti-tumor necrosis factor (TNF) agents, etc. with the
    exception of steroids

    - Administration of a live or live attenuated vaccine within 6 weeks of initiation of
    study therapy

    - Ongoing treatment with systemic steroids at dose equivalent to greater than prednisone
    10 mg daily or other immunosuppressive medication within 7 days of initiation of study
    therapy

    - Inhaled steroids will be permitted

    - Topical steroids for cutaneous manifestations of MF/SS will be permitted below:

    - Continued use of select concomitant topical steroids is permitted if the
    patient has remained clinically stable for at least 4 weeks.

    - Patients who are on low or moderate potency topical corticosteroids may
    participate if they are on a stable dose for at least 4 weeks before
    enrollment. Local injections of corticosteroids are acceptable; all
    corticosteroids will be reported as concomitant medications.

    - Patients prescribed prednisone 10 mg PO daily or less (or equivalent) will not be
    excluded

    - Concomitant use of another systemic therapy for MF/SS. Patients must have the
    following minimum wash-out from previous treatments:

    - At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy
    (TSEBT)

    - At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting
    monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the
    washout is at least 16 weeks

    - At least 2 weeks or 5 half-lives for systemic retinoids, interferons, vorinostat,
    romidepsin, and denileukin diftitox, or anticancer investigational agents that
    are not defined as immunotherapy

    - At least 2 weeks for local radiation therapy

    - At least 1 week for topical retinoids, nitrogen mustard, or imiquimod

    - Concomitant malignancy requiring active systemic therapy, excluding adjuvant endocrine
    therapy with the following exceptions:

    - Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will
    not be excluded

    - Adjuvant or maintenance therapy to reduce the risk of recurrence of another
    malignancy (excluding cutaneous T-cell lymphoma) is permissible after discussion
    with the Washington University principal investigator

    - Subjects with previous malignancies are eligible if disease-free for > 2 years

    - History of solid organ transplantation or allogeneic bone marrow transplantation

    - Uncontrolled infection requiring systemic antimicrobials: Patients on antibacterial,
    antifungal, and antiviral prophylaxis will not be excluded if all other exclusion /
    inclusion criteria are met

    - Patients with active cytomegalovirus (CMV) (positive serology for anti-CMV IgM
    antibody and negative for anti-CMV IgG antibody or positive CMV PCR with clinical
    manifestations consistent with active CMV infection) and requiring therapy will be
    excluded from participation in the study. Carriers will be monitored per institutional
    guidelines

    - Patients should be excluded if they have known active hepatitis B (e.g. hepatitis B
    virus [HBV] surface antigen [HBsAg] reactive) or hepatitis C (e.g. hepatitis C virus
    [HCV] ribonucleic acid [RNA] [qualitative] is detected)

    - Patients with chronic HBV or HCV are defined as patients with positive hepatitis
    B serology: Patients with a negative HBsAg and a positive hepatitis B core
    antibody (HBcAb) require an undetectable/negative hepatitis B deoxyribonucleic
    acid (DNA) test (e.g. polymerase chain reaction [PCR] test) to be enrolled, and
    will require prophylactic antiviral treatment initiated prior to the first dose
    of study drug, and continued until approximately 6 to 12 months after completion
    of study drug(s)

    - Patients who have not recovered from adverse events due to prior anti-cancer therapy
    (i.e., have residual toxicities > grade 1), with the exception of alopecia and
    neuropathy

    - Patients who are receiving any other investigational agents

    - History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to duvelisib or nivolumab

    - Patients receiving any medications or substances that are strong inhibitors or
    inducers of CYP3A4 are ineligible to start study therapy. Patients who are on strong
    inhibitors or inducers of CYP3A4 may start study therapy if discontinued 5 half lives
    before start of study therapy. Because the lists of these agents are constantly
    changing, it is important to regularly consult a frequently-updated medical reference.
    As part of the enrollment/informed consent procedures, the patient will be counseled
    on the risk of interactions with other agents, and what to do if new medications need
    to be prescribed or if the patient is considering a new over-the-counter medicine or
    herbal product

    - Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
    or active infection, interstitial lung disease or active, non-infectious pneumonitis,
    congestive heart failure New York Heart Association (NYHA) grade >= 3, unstable angina
    pectoris, and cardiac arrhythmia

    - Patients with psychiatric illness/social situations that would limit compliance with
    study requirements

    - Baseline QT interval corrected with Fridericia's method (QTcF) > 500 ms

    - Note: Criteria does not apply to subjects with a right or left bundle branch
    block

    - Pregnant women are excluded from this study because nivolumab has the potential for
    teratogenic or abortifacient effects. Because there is an unknown but potential risk
    for adverse events in nursing infants secondary to treatment of the mother with
    nivolumab, breastfeeding should be discontinued if the mother is treated with
    nivolumab. These potential risks may also apply to other agents used in this study

    - Patients who have had evidence of active or acute diverticulitis, intra-abdominal
    abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are
    known risk factors for bowel perforation should be evaluated for the potential need
    for additional treatment before coming on study

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

    Drug, Biologic/Vaccine
    Cancer, Cutaneous b-cell lymphoma, Lymphoma, Non-Hodgkin's lymphoma
    Cancer treatment, Chemotherapy, Duvelisib [USAN:INN], Hematopoietic system, MDX-1106, Medical Oncology, Mycosis fungoides (clinical), Sezary's disease, duvelisib, nivolumab
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    A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies

    Study of Oral LOXO-338 in Patients With Advanced Blood Cancers

    Prashant Kapoor
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-306032-P01-RST
    21-010080
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    Inclusion Criteria:


    - B-cell malignancy.

    - Patients must have received prior therapy.

    - Patients must have an objective indication for therapy.

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

    - Anticipated life expectancy of greater than or equal to (≥) 12 weeks.

    - Adequate bone marrow function.

    - Adequate hepatic function.

    - Creatinine clearance of ≥ 60 milliliters (mL)/minute.

    - Ability to swallow tablets.

    - Ability to comply with outpatient treatment, laboratory monitoring, and required
    clinic visits for the duration of study participation.

    - Prior treatment-related adverse events (AEs) must have recovered to grade less than or
    equal to (≤) 1 or pretreatment baseline, with the exception of alopecia.

    - Men with partners of childbearing potential or women of childbearing potential (WOCBP)
    must agree to use highly effective birth control.

    - WOCBP must not be pregnant.

    - Additional Inclusion Criteria for Patients with AL Amyloidosis

    - In Part 1 Dose Expansion, patients with AL amyloidosis are eligible based on
    prior detection of primary systemic light-chain amyloidosis.

    - Must have measurable disease of AL amyloidosis.

    - Prior local fluorescence in-situ hybridization (FISH) testing results for
    t(11;14) are required to be submitted prior to enrollment.


    Exclusion Criteria:


    - Prior to identification of an appropriate RP2D (Dose Expansion) of LOXO-338, a history
    of known, active or suspected:

    - Richter's transformation to diffuse large B-cell lymphoma (DLBCL),
    prolymphocyticleukemia, or Hodgkin lymphoma

    - Transformed low grade lymphoma

    - Burkitt or Burkitt-like lymphoma

    - Diffuse large B-cell lymphoma

    - AL amyloidosis

    - Multiple myeloma

    - Lymphoblastic lymphoma or leukemia

    - Posttransplant lymphoproliferative disorder

    - Known or suspected history of central nervous system (CNS) involvement.

    - History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen
    receptor-modified T cell (CAR-T) therapy within the past 60 days and with any of the
    following:

    - Active graft versus host disease (GVHD)

    - Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T
    therapy

    - Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms
    of neurotoxicity Grade > 1 from CAR-T therapy

    - Ongoing immunosuppressive therapy

    - Known human immunodeficiency virus (HIV) positive, regardless of cluster of
    differentiation 4 (CD4) count. Unknown or negative status eligible.

    - Inability to take necessary uric acid lowering agents (i.e., allopurinol, rasburicase,
    orfebuxostat).

    - Concurrent anticancer therapy.

    - Concurrent treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
    that can include antifungals.

    - Use of ≥ 20 milligrams (mg) prednisone once a day (QD) or equivalent dose of steroid
    per day, within 7 days of start of study treatment. Patients may not be on any dose of
    prednisone intended for antineoplastic use.

    - Vaccination with a live vaccine within 28 days prior to start of study therapy.

    - Major surgery within four weeks of planned start of study therapy Prolongation of the
    QT interval corrected by Fridericia's Formula for heart rate (QTcF) greater than (>)
    470 milliseconds (msec).

    - Clinically significant cardiovascular disease.

    - Female patient who is pregnant or lactating.

    - Active second malignancy which may preclude assessment of DLT.

    - Clinically significant active malabsorption syndrome including surgical resection of
    small intestine or other condition likely to affect gastrointestinal (GI) absorption
    of the orally administered study drugs.

    - Active hepatitis B or C infection.

    - Evidence of other clinically significant uncontrolled condition(s) including, but not
    limited to, uncontrolled systemic infection (viral, bacterial, or fungal) or other
    clinically significant active disease process.

    - Active uncontrolled auto-immune cytopenia.

    - Additional Exclusion Criteria for Patients with AL Amyloidosis (Part 1 Dose-Expansion)

    - Previous or current diagnosis of symptomatic MM.

    - Heart failure that, in the opinion of the Investigator, is on the basis of
    ischemic heart disease.

    - Supine systolic blood pressure < 90 mmHg, or symptomatic orthostatic hypotension
    in the absence of volume depletion.

    - N-terminal pro hormone natriuretic peptide (NT-proBNP) > 8500 ng/L (or BNP > 700
    ng/L if NT-proBNP is not available by local or central testing).

    - Additional exclusion criteria for patients enrolled to part 2: LOXO-338 and
    pirtobrutinib combination

    - Prior progression or intolerance to pirtobrutinib.

    - Patients requiring therapeutic anticoagulation with warfarin.

    - Known hypersensitivity to any component or excipient of pirtobrutinib.

    - In patients with history of myocardial infarction or congestive heart failure,
    documented left ventricular ejection fraction (LVEF) by any method of ≤ 45
    percent (%) in the 12 months prior to planned start of study treatment.

    - History of uncontrolled or symptomatic arrhythmias including grade ≥ 3 arrhythmia
    on a prior BTK inhibitor.

    - History of major bleeding on a prior BTK inhibitor.

    - Current treatment with strong permeability glycoprotein (P-gp) inhibitors.

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    Mayo Clinic — Rochester, MN

    Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A single institution, single-blinded, randomized clinical trial

    Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty

    Matthew Abdel
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-306039-H01-RST
    21-010044
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    Inclusion Criteria:

    • ASA classification I to III, older than or equal to 18 years old.
    • All genders.
    • Presenting for primary total knee replacement for degenerative joint disease.
    • Patient capable of providing their own informed consent.


    Exclusion Criteria:

    • Vulnerable study populations including prisoners.
    • Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
    • Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
    • Patients unable to provide their own informed consent.
    • Pregnancy.
    • Patients with documented chronic pain syndromes.
    • Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
    • BMI > 45 kg/m^2.
    • Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
    • Patients with impaired cognitive function.
    • Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.

    Eligibility last updated 10/12/21. Questions regarding updates should be directed to the study team contact.

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    2020-0641, Pembrolizumab in Combination with Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-mutated Anaplastic Thyroid Cancer

    Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

    Mabel Ryder
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-306042-P01-RST
    21-010193
    Show full eligibility criteria
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    Inclusion Criteria:

    • Pathologic findings supporting the clinical impression of anaplastic thyroid  carcinoma. Diagnosis may include consistent with or suggestive of terminology  associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous  carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
    • Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E  immunohistochemistry on tumor tissue, genetic/molecular testing of tumor, or cell free  (cf)NDA liquid biopsy.
    • Have measurable disease based on RECIST 1.1.
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Total bilirubin ≤ 3 x ULN for  patients with Gilbert's syndrome.
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase  [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])  ≤ 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases).
    • Serum creatinine ≤ within 1.5 x ULN.
    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L.
    • Platelets ≥ 100 x 10^9/L.
    • Hemoglobin ≥ 9.0 g/dL or 5.6 mmol/L.
    • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless  participant is receiving anticoagulant therapy as long as PT or activated partial  thromboplastin time (aPTT) is within therapeutic range of intended use of  anticoagulant.
    • Subjects must be willing to undergo tumor biopsy prior to and after the run-in with dabrafenib/trametinib (DT), unless in the opinion of the treating physician, a biopsy is not feasible or safe. Subjects must be willing to ultimately undergo surgery if  their tumor becomes surgically resectable. Research subjects retain the right to  refuse any research interventions.
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.  Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
    • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
    • A male participant must agree to use a contraception of this protocol during the  treatment period and for at least 8 months after the last dose of study treatment and  refrain from donating sperm during this period.
    • A female participant is eligible to participate if she is not pregnant, not  breastfeeding, and at least one of the following conditions applies:  
      • Not a woman of childbearing potential (WOCBP); OR
      • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment.


    Exclusion Criteria:
     

    • Significant cardiovascular impairment: history of congestive heart failure greater  than New York Heart Association (NYHA) class II.
    • Untreated brain metastases.
    • Prior chemotherapy within < 1 week prior to study day 1 or patients who have not  recovered (i.e., ≤ grade 2) from adverse events due to a previously administered  agent, except for patients who have been on dabrafenib/trametinib (DT) according to  the standard run-in outlined in the trial schema.
    • Has active autoimmune disease that has required systemic treatment in the past 2 years  (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid  replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • History of human immunodeficiency virus (HIV) or active hepatitis B (chronic or acute)  or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive  anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. However,  patients with past or resolved hepatitis B virus (HBV) should be monitored for  reactivation by a specialist. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic  acid (RNA).
      • Note: no testing for HIV, hepatitis B and hepatitis C is required unless  mandated by local heath authority.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
    • Has received a live or live-attenuated vaccine within 30 days prior to the first dose  of study drug. Administration of killed vaccines is allowed.
    • Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients.
    • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required  steroids or has current pneumonitis/interstitial lung disease.
    • Has known psychiatric or substance abuse disorders that would interfere with  cooperation with the requirements of the trial.
    • Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin  [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]). A women of childbirth potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to the first infusion will be excluded. If the urine test is  positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    • More than 30 days of DT therapy prior to enrollment.
    • A known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension.

    Eligibility last updated 9/27/21. Questions regarding updates should be directed to the study team contact.

     

    Drug, Procedure/Surgery, Radiation, Other
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    Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis (APPLe)

    Advancing Prevention of Pulmonary Fibrosis

    Teng Moua
    All
    40 years to 75 years old
    This study is NOT accepting healthy volunteers
    2021-306157-P01-RST
    21-010596
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    Inclusion Criteria:

    • Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP).
    • Age at least 40 years old and younger than 75 years old.


    Exclusion Criteria:

    • Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent.
    • Other genetic diseases associated with interstitial lung disease.
    • Pregnant women.

    Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

     

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    Mayo Clinic — Rochester, MN

    A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI) (iTBS rTMS in MCI)

    iTBS rTMS in Mild Cognitive Impairment

    Maria Lapid
    All
    18 years and over
    Not Applicable, Feasibility
    This study is NOT accepting healthy volunteers
    2021-306168-H01-RST
    21-010661
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    Inclusion Criteria

    - Must speak English fluently

    - Diagnosis of MCI as defined by:

    - Clinical diagnosis by a neurologist

    - Neuropsychological testing support of MCI

    - Meet criteria for MCI

    - Subjective cognitive decline reported by participant and/or an informant

    - Objective memory impairment in one or more cognitive domains for age

    - Essentially preserved general cognitive function

    - Largely intact functional activities

    - Does not meet criteria for dementia as judged by a clinician

    - Eligible for transcranial magnetic stimulation (TMS) based on safety criteria

    - Clinical Dementia Rating=0.5

    - Geriatric Depression Scale score less than 6

    - Medically stable and in good general health

    - Not pregnant, lactating, or of childbearing potential

    - Stable medication regimen for at least 4 weeks prior to baseline visit

    - Adequate visual and auditory abilities to complete neuropsychological testing

    - Ability to provide informed consent

    - Have a care partner who is available to accompany the participant to study visits for
    the duration of the protocol.

    Exclusion Criteria

    - Inability to communicate in the English language

    - Meet criteria for dementia

    - Contraindications to TMS or MRI, including patients who have

    - conductive, ferromagnetic or other magnetic-sensitive metals implanted in their
    head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted
    electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or
    jewelry)

    - active or inactive implants, including deep brain stimulators, cochlear implants,
    vagus nerve stimulators or implanted device leads

    - Any true positive findings on the TMS safety screening form

    - Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within
    the past 12 months

    - History of epilepsy or seizures

    - Medical conditions or use of medications that increase risk of seizures

    - History of traumatic brain injury

    - History of intracranial mass or lesion

    - History of stroke, including hemorrhagic stroke and ischemic stroke

    - Medications associated with seizures (Examples: Analgesics
    •Opioids (e.g.,
    meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab;
    Antimicrobials
    •Carbapenems (e.g., imipenem), Cephalosporins (fourth
    generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins;
    Hypoglycemic agents; Immunosuppressants
    •Azathioprine, Cyclosporine,
    Mycophenolate, Tacrolimus; Psychiatric medications
    •Antipsychotics, Atomoxetine,
    Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs -
    Aminophylline, Theophylline; Stimulants
    •Amphetamines, Methylphenidate;
    Sympathomimetics and decongestants
    •Anorexiants (e.g., diethylpropion,
    phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)

    - Psychiatric disorders

    - Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform
    disorder), any history

    - Primary mood disorder (major depressive disorder, bipolar disorder) within the
    past 12 months

    - Substance use disorder (except caffeine and nicotine) within the past 12 months

    - Active symptoms of depression, anxiety, mania, psychosis, or substance use (except
    caffeine and nicotine) within the past year

    - Active symptoms of depression will be identified based on geriatric depression
    scale ≥ 6

    - Other active symptoms of psychiatric conditions to be determined by study
    investigators

    - Sleep disorders that are considered clinically significant and not sufficiently
    treated by the investigative team, including untreated obstructive sleep apnea
    (apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior
    disorder, untreated/suboptimally treated restless legs syndrome

    - Pregnancy or suspected pregnancy

    - Participation in another concurrent interventional clinical trial

    - Any unstable medical condition

    - Inability to provide informed consent

    - Inability to adhere to the protocol

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

    Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial Shunt System (ALt FLOW US) (ALt FLOW US)

    Early Feasibility Study - Transcatheter Atrial Shunt System

    Trevor Simard
    All
    18 years and over
    Not Applicable, Early Feasibility
    This study is NOT accepting healthy volunteers
    2021-306204-P01-RST
    21-010797
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    Inclusion Criteria:


    1. Signed and dated IRB approved study consent form prior to study related procedures

    2. ≥ 18 years old

    3. Chronic symptomatic Heart Failure (HF) documented by the following:

    1. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory
    NYHA class IV AND

    2. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or
    treatment with intravenous (IV) or intensification of oral diuresis for HF in a
    healthcare facility (emergency department/acute care facility) within the 12
    months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus
    rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal
    sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.

    4. In the judgment of the investigator, subject is on stable Guideline Directed Medical
    Therapy (GDMT) for heart failure and management of potential comorbidities according
    to current ACCF/AHA Guidelines and that is expected to be maintained without change
    for 3 months

    5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine
    ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP)
    exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine
    ergometer exercise stress test as measured at end-expiration

    6. Willing to attend study follow-up assessments for up to 5 years

    Inclusion Criteria for RV Overload group only:

    I1B. Pulmonary Hypertension (PH) that maybe reversible, documented by the following:

    1. Pulmonary Vascular Resistance (PVR) > 4 Wood Units at rest AND

    2. Mean Pulmonary Artery Pressure (mPAP) ≥ 25 mmHg at rest AND

    3. Successful reversibility of PH under a resting Sodium Nitroprusside challenge where
    success is defined as a lowering of the PVR by ≥ 20% to a level < 4 Wood Units while
    maintaining a Systolic Blood Pressure ≥ 90 mmHg


    Exclusion Criteria:


    1. Severe heart failure defined as one or more of the below:

    1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF

    2. If BMI < 30, Cardiac index < 2.0 L/min/m2

    3. If BMI ≥ 30, cardiac index < 1.8 L/min/m2

    4. Inotropic infusion (continuous or intermittent) within the past 6 months

    5. Patient is on the cardiac transplant waiting list

    6. LVEF < 20%

    2. Presence of significant valve disease defined by the site cardiologist as:

    1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS

    2. Tricuspid valve regurgitation defined as grade > 2+ TR

    3. Aortic valve disease defined as > 2+ AR or > moderate AS

    3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current
    indication for coronary revascularization

    4. Valve replacement or surgical annuloplasty within the past 12 months

    5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA)
    within the past 6 months

    6. Hemodynamic instability within 30 days of scheduled implant procedure

    7. Patient requiring surgery under general anesthesia for any reason within 30 days of
    scheduled implant procedure

    8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive
    pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)

    9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or
    estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis

    10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases,
    total bilirubin, or alkaline phosphatase

    11. Performance of the 6 minute walk test with a distance <50m OR >600m

    12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin
    (analogue); or has a documented coagulopathy

    13. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be
    adequately medicated

    14. Known hypersensitivity to Nickel and/or Tantalum

    15. In the judgment of the investigator, life expectancy <12 months for noncardiovascular
    reasons

    16. In the opinion of the investigator, the subject is not an appropriate candidate for
    the study

    17. Anatomy (including implantable devices) that is not compatible with the Edwards
    Transcatheter Atrial Shunt System

    18. Active endocarditis or infection within 3 months of scheduled implant procedure

    19. Currently participating (e.g., undergoing trial specific exams/treatment/procedures)
    in an investigational drug or device study. Note: trials requiring extended follow-up
    for products that were investigational but have since become commercially available
    are not considered investigational trials.

    20. Patient is a current intravenous drug user

    21. Positive serum pregnancy test in female subjects of child-bearing potential or nursing
    mothers or planning on becoming pregnant during the duration of the trial

    22. Patient is under guardianship

    23. Known pre-existing shunting, determined to be clinically significant by the
    investigator

    24. (Not applicable to RV Overload group) Right ventricular dysfunction, defined by the
    site cardiologist as:

    1. More than mild RV dysfunction as estimated by TTE; OR

    2. TAPSE <1.4 cm; OR

    3. RV size ≥ LV size as estimated by TTE; OR

    4. Echocardiographic or clinical evidence of congestive hepatopathy

    25. Evidence of pulmonary hypertension with PVR >4 Wood units

    Exclusion Criteria for RV Overload group only:

    E1B. Propensity for increased Right ventricular dysfunction, defined by the site
    cardiologist as:

    1. More than moderate RV dysfunction as estimated by TTE; OR

    2. TAPSE <1.2 cm; OR

    3. RV size ≥ LV size as estimated by TTE; OR

    4. Right Atrial Pressure (RAP) > 18 mm Hg; OR

    5. Echocardiographic or clinical evidence of congestive hepatopathy;

    Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

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    Location Contacts
    Mayo Clinic — Rochester, MN