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10476 / A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers

A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers

Lionel Aurelien Kankeu Fonkoua
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306991-P01-RST
22-000900
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Inclusion Criteria:


- Pathologically confirmed biliary tract cancer, having received at least 1 prior line
of systemic therapy, and received no more than 2 prior lines of therapy in the
metastatic setting (disease recurrence =< 6 months from the last dose of adjuvant
therapy in resected patients will be considered the first line of therapy)

- Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma
(EHC), and gallbladder carcinoma (GBC), but not Ampulla of Vater cancers

- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1

- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) in patients < 18 years
of age, children are excluded from this study

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)

- Absolute neutrophil count >= 1,500/mcL

- Hemoglobin >= 9.0 g/dl

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Patients with
known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)

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

- Serum creatinine =< 1.5 x institutional ULN OR

- Creatinine clearance > 30 mL/min/1.73 m^2 (calculated by Cockcroft-Gault method) for
patients with creatinine levels above institutional normal

- Albumin >= 3.0 g/dL

- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This
applies only to patients who do not receive therapeutic anticoagulation; patients
receiving therapeutic anticoagulation, such as low-molecular-weight heparin or
warfarin, should be on a stable dose)

- Creatine kinase (CK)/creatine phosphokinase (CPK) < 5 x ULN

- Oxygen saturation >= 92% on room air

- Left ventricular ejection fraction > 50%

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

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load

- Patients must be willing to undergo 2 sets of core needle biopsies. If possible,
biopsied sites should be different than those used for measurable disease/RECIST
measurements, but this is not mandatory

- Patients must have an estimated life expectancy of greater than 3 months

- Patients must be able to swallow pills

- Patients should not have evidence of retinal pathology on ophthalmologic examination;
or neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular
macular degeneration

- The effects of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) on the developing
human fetus are unknown. For this reason, women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and 5
months after the last dose of atezolizumab. 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 5 months (150 days) after completion of atezolizumab,
cobimetinib, and CDX-1127 (varlilumab) administration

- Ability to understand and the willingness to sign a written informed consent document


Exclusion Criteria:


- Patients with prior allogeneic bone marrow transplantation within the past 5 years or
prior solid organ transplantation at any point

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events (other than alopecia or neuropathy) due to agents
administered more than 4 weeks earlier. However, the following therapies are allowed:

- Hormone-replacement therapy or oral contraceptives

- Herbal therapy > 1 week prior to randomization (herbal therapy intended as
anticancer therapy must be discontinued at least 1 week prior to randomization)

- Palliative radiotherapy for bone metastases > 2 weeks prior to randomization

- Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1or other immune checkpoint
inhibitor therapeutic antibodies or pathway-targeting agents. Patients who have only
received previous durvalumab (anti-PD-L1) as part of first line in combination with
gemcitabine and cisplatin (TOPAZ-1 regimen [NCT03875235]) are eligible

- Prior treatment with MEK or ERK inhibitors

- Treatment with any other investigational agent within 4 weeks prior to randomization

- Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to randomization

- Treatment with systemic immunosuppressive medications (including, but not limited to,
prednisone (> 10 mg), cyclophosphamide, tacrolimus, sirolimus, azathioprine,
methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2
weeks prior to randomization.

- Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.

- The use of physiologic doses of systemic corticosteroids and mineralocorticoids
(e.g., fludrocortisone) for patients with orthostatic hypotension or
adrenocortical insufficiency is allowed.

- The use of topical and inhaled corticosteroids are allowed due to low systemic
absorption

- Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of
bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is
allowed

- Presence of therapeutically actionable mutation with approved targeted therapy (e.g.
FGFR fusion patients are eligible for study therapy in the 3rd line setting). Patient
must have received somatic mutation testing (tissue or liquid) prior to enrollment

- Clinically significant ascites (palpable on exam, paracentesis in last 3 months,
and/or symptomatic)

- Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS
metastases are excluded, with the following exceptions:

- Patients with asymptomatic treated CNS metastases may be enrolled, provided all
the criteria listed above are met as well as the following:

- Radiographic demonstration of improvement upon the completion of CNS
directed therapy and no evidence of interim progression between the
completion of CNS directed therapy and the screening radiographic study

- No stereotactic radiation or whole-brain radiation within 28 days prior to
randomization

- Screening CNS radiographic study >= 4 weeks from completion of radiotherapy
and >= 2 weeks from discontinuation of corticosteroids

- Follow-up brain imaging 3 months after central nervous system (CNS)-directed
therapy shows no evidence of progression

- History of malignant bowel obstruction

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
Chinese hamster ovary cell products, chimeric, humanized, or other recombinant human
antibodies or fusion proteins

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to atezolizumab, cobimetinib, or CDX-1127 (varlilumab)

- Patients receiving any medications or substances that are considered moderate to
strong inhibitors or inducers of CYP3A and are not able to switch to an alternative
that minimizes interaction potential will ineligible. Coadministration of cobimetinib
with a strong CYP3A4 inhibitor can increase cobimetinib systemic exposure
significantly (e.g. itraconazole increased serum systemic cobimetinib exposure by 6.7
fold). On the other end, coadministration of cobimetinib with a strong CYP3A inducer
may decrease cobimetinib systemic exposure by more than 80% thus reducing its
efficacy. Because the lists of these agents are constantly changing, it is important
to regularly consult a frequently-updated list such as
http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the
Physicians' Desk Reference may also provide this information. 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 on mild inhibitors or inducers of CYP3A are allowed

- Patients with a known clinically significant liver disease, including active viral,
alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.

- 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.

- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)

- Patients who have received immunosuppressive treatment for systemic autoimmune
disease, including, but not limited to, systemic lupus erythematosus, rheumatoid
arthritis, inflammatory bowel disease, vascular thrombosis associated with
antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple
sclerosis, vasculitis, or glomerulonephritis within the last 2 years.

- Patients with a history autoimmune endocrine disorders on stable doses of
physiologic hormone replacement may be eligible.

- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may
be eligible.

- Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would
be excluded) are permitted provided that they meet the following conditions:

- Patients with psoriasis must have a baseline ophthalmologic exam to rule out
ocular manifestations

- Rash must cover less than 10% of body surface area (BSA)

- Disease is well controlled at baseline and only requiring low potency
topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,
fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)

- No acute exacerbations of underlying condition within the last 12 months
(not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors; high potency or
oral steroids)

- Patients with history Guillain-Barre syndrome or myasthenia gravis at any point
will not be eligible

- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
tomography (CT) scan. History of radiation pneumonitis in the radiation field
(fibrosis) is permitted

- Patients with active tuberculosis (TB) are excluded

- Severe infections within 4 weeks prior to randomization, including, but not limited
to, hospitalization for complications of infection, bacteremia, or severe pneumonia

- Signs or symptoms of infection within 2 weeks prior to randomization

- Received oral or intravenous (IV) antibiotics within 2 weeks prior to randomization

- Patients receiving prophylactic/suppressive antibiotics will not be eligible

- Major surgical procedure within 28 days prior to randomization or anticipation of need
for a major surgical procedure during the course of the study

- Administration of a live, attenuated vaccine within 4 weeks before randomization or
anticipation that such a live, attenuated vaccine will be required during the study
and up to 5 months after the last dose of atezolizumab.

- Influenza vaccination should be given during influenza season only (approximately
October to March). Patients must not receive live, attenuated influenza vaccine
within 4 weeks prior to Randomization or at any time during the study.

- Coronavirus disease 2019 (COVID-19) vaccination is not exclusionary but should be
administered at least 7 days before study start

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

- Pregnant women are excluded from this study because one or more study agents have 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 atezolizumab, cobimetinib, and CDX-1127 (varlilumab), breastfeeding should
be discontinued if the mother is treated with atezolizumab, cobimetinib, and CDX-1127
(varlilumab)

- Patients who are using ethinyl estradiol containing oral contraceptives when
administered concomitantly with cobimetinib, are excluded due to increased risk of
venous thromboembolism

- Patients with a history of clinically significant cardiac dysfunction, including the
following:

- Left ventricular ejection fraction (LVEF) below institutional lower limit of
normal (LLN) or below 50%, whichever is lower

- Current unstable angina

- Current symptomatic congestive heart failure (CHF) of New York Heart Association
class 2 or higher

- Uncontrolled hypertension >= grade 2 (patients with a history hypertension
controlled with anti-hypertensives to =< grade 1 are eligible).

- Uncontrolled arrhythmias

- Myocardial infarction, severe/unstable angina, symptomatic chronic heart failure
(CHF), cerebrovascular accident or transient ischemic attack within the previous
6 months

- History of treatment with cardiotoxic agents

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Stephen Ansell
All
18 years to 101 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306939-P01-RST
22-000750
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Inclusion Criteria:


- ≥ 16 years of age at the time of obtaining informed consent

- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening

- At least one PET-avid measurable lesion according to Modified Lugano Criteria after
the last line of therapy.

- Confirmed histological diagnosis of active relapse/refractory cHL

- Failed at least 2 prior lines of systemic therapy.

- No previous treatment with anti-TIM-3.

- Adequate organ and bone marrow function

- Non-pregnant women and willingness of female patients to avoid pregnancy or male
participants willing to avoid fathering children through highly effective methods of
contraception

- Minimum body weight ≥ 40 kg for all participants.


Exclusion Criteria:


- Unresolved toxicities of ≥ Grade 2 from prior therapy

- Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy

- Patients with CNS involvement or leptomeningeal disease.

- History of organ transplantation (e.g., stem cell or solid organ transplant).

- Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose
of study intervention.

- Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B,
chronic or active hepatitis C, active COVID-19 infection

- History of arrhythmia which is requires treatment, symptomatic or uncontrolled atrial
fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia

- Uncontrolled intercurrent illness.

- Active or prior documented pathologically confirmed autoimmune or inflammatory
disorders.

- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation
pneumonitis requiring steroid treatment, or any evidence of clinically active ILD

- Other invasive malignancy within 2 years prior to screening

- Congenital long QT syndrome or history of QT prolongation associated with other
medications that cannot be changed or discontinued based on a cardiologist assessment

- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of study intervention

- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal
therapy for cancer treatment.

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

Eligibility last updated 11/22/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma (FAPI-46 PDAC)

Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma

Ajit Goenka
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307706-P01-RST
22-003295
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Inclusion Criteria:


1. Pathologically confirmed pancreatic ductal adenocarcinoma

2. Treatment-naïve

3. Staged as resectable or borderline-resectable

4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e.,
chemotherapy, radiation therapy, or combination) and subsequent possible surgical
resection

5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

6. Age ≥ 18 years

7. Completed informed consent as determined per the IRB of record


Exclusion Criteria:


1. Pregnant as determined by a pregnancy test as per institutional guidelines for
individuals of child-bearing potential

2. Declining to use effective contraceptive methods during the study (for individuals of
child-producing potential)

3. Need for emergent surgery that would be delayed by participation

4. Bacterial, viral, or fungal infections requiring systemic therapy

5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney
failure, liver failure, systemic or local inflammatory or autoimmune diseases or other
conditions) that in the opinion of the investigator, physician of record and/or Sofie
could compromise patient safety and/or protocol objectives.

6. Known diagnosis of autoimmune disorders

7. Patients receiving any other investigational agent within the past 28 days

8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits
to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of
the [68Ga]FAPI-46 injection.

9. Known hypersensitivity to any excipients used in [68Ga]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

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

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Early Feasibility Study of the Acclaim Cochlear Implant System (Early Feasibility Study of the Acclaim Cochlear Implant System)

A Study to Evaluate Feasibility of the Acclaim Cochlear Implant System

Colin Lea Driscoll
All
18 years and over
Early Feasibility
This study is NOT accepting healthy volunteers
2020-300207-P01-RST
20-003924
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Inclusion Criteria:

Subjects must meet ALL of the following criteria:

  • Signed and dated informed consent form.
  • At least 18 years of age at time of implant.
  • Good health and absence of significant morbidity.
  • Ability to read, write, comprehend, and speak fluently in English.
  • Post-lingually deafened.
  • Pure-tone thresholds indicate at least a bilateral moderate-to-severe sensorineural hearing loss:
    • Low frequency pure-tone average greater than or equal to 40 dB HL at 250, 500, 750, and 1,000 Hz; and
    • Severe or profound hearing loss greater than or equal to 70 dB HL at 2 KHz and above.
  • Limited benefit from amplification, defined by aided CNC word recognition ≤ 40% in the ear to be implanted and ≤ 60% in the best aided condition.
  • Normal middle ear function based on otoscopy and tympanometry (Type A, AS, or AD).
  • An accessible cochlear lumen and intact cochlear nerve, and no known lesions on the auditory nerve or acoustic areas of the central nervous system.
  • Ability to undergo surgery and post-implant rehabilitation.


Exclusion Criteria:

Subjects will be excluded if any of the following are present:

  • More than ten years of documented severe-to-profound hearing loss.
  • Air-bone gap greater than 10 dB at two of the four following frequencies: 500, 1000, 2000, and 4000 Hz.
  • Prior surgery in the middle ear, inner ear, neck, or infraclavicular region that is anticipated to prevent proper placement or function of the Acclaim CI.
  • Ossification, malformation, or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  • Hearing impairment due to retrocochlear pathology.
  • Diagnosed auditory neuropathy.
  • Unwillingness or inability of the candidate to comply with all required investigational testing and follow-up visits, in the opinion of the Investigator.
  • Known hypersensitivity or contraindication to procedural or post-procedural medications that cannot be adequately managed medically.
  • Known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium, or platinum.
  • Currently using other active implants that are expected to interfere with the Acclaim CI positioning or function.
  • Participation or planned participation in an investigational drug or another device study within the three months prior to screening. Participation in clinical trials or registries where only measurements and/or samples are taken (e.g., no test device or test drug) is allowed.
  • Pregnancy at the time of implant or plans to become pregnant within two (2) years of enrollment.

Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Feasibility of Smartphone App MindLAMP in Developing Digital Phenotypes in Depression (LAMP)

A Study to Evaluate the Feasibility of MindLAMP Application to Develop Digitial Phenotypes in Depression

Mark Frye
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
2020-301932-H01-AUAC
20-008865
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Inclusion Criteria - Patients:

  • Age 18-65 years.
  • Currently depressed patients [n=100 major depressive disorder (MDD), n=100 bipolar (50 BPI, 50 BII)] confirmed by Mini International Neuropsychiatric Interview (MINI) active in clinical care.
  • Use a compatible smartphone. If participant has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, a smartwatch will be offered for the 12 week trial.

Inclusion Criteria
•Healthy Controls:

  • Age 18-65 years old.
  • 100 age- and sex- matched controls as confirmed by Mini International Neuropsychiatric Interview (MINI).
  • Use a compatible smart phone. If participating has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, an accelerometer will be offered for the 12 week trial.

Exclusion Criteria
•Patients:

  • Inability to understand written or spoken English.
  • Inability to provide valid written informed consent because of an identified/diagnosed intellectual disability, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
  • Primary reasons for treatment are not related to depression  (e.g., are due to an adjustment disorder, personality disorder  effect of substances or substance abuse, or exacerbation of a comorbid psychiatric disorder) based on available information, review of EHR, and/or investigator judgement.
  • Psychotic disorder or Current psychotic features;
  • Active suicidal ideation (QIDS-C question 12 score of > 2 and investigator judgement).
  • Women with known pregnancy at time of enrollment.*

Exclusion Criteria
•Healthy Controls:

  • Inability to understand written or spoken English;
  • Inability to provide valid written informed consent because or mental retardation, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
  • Has had a current  psychiatric diagnosis within the last year.
  • Currently taking a psychotropic medication.
  • Women with known pregnancy at time of enrollment.*

* Healthy controls will not be receiving any psychiatric treatment during the study. For depressed female patients of child bearing potential who will be followed naturalistically, it is possible they may receive pharmacotherapy or other clinical intervention from her mental health provider. It will be up to the clinician providing care to determine the need to clarify the pregnancy status.

* If a patient or healthy control becomes pregnant at anytime throughout the study, the patient will be withdrawn from the study.

Eligibility last updated 6/7/22.  Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic Health System — Austin, MN

AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Stephanie Polites
All
up to 50 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-308493-P01-RST
22-006188
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Inclusion Criteria:


- Patients must be < 50 years at the time of enrollment.

- Patient must have eligibility confirmed by rapid central imaging review.
 
- Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size.

- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.

- Patients must have a histological diagnosis of osteosarcoma.

- Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.

- Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.

- Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.

- Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least
equivalent to MAP.


Exclusion Criteria:


- Patients with unresectable primary tumor.

- Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central
lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).

- Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.

- Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy.

Note: Once the patient has been enrolled on the study,
additional computed tomography (CT) scans are not anticipated prior to thoracic surgery.

Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.

- Patients with evidence of extrapulmonary metastatic disease.

- Patients who received pulmonary surgery for lung metastasis prior to enrollment.

- All patients and/or their parents or legal guardians must sign a written informed consent.

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Procedure/Surgery
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Mayo Clinic — Rochester, MN

A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Emma Fortune Ngufor
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308922-H01-RST
22-007713
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Inclusion Criteria:

  • Patients self-report as being > 1 year postmenopausal.
  • Patients are able to walk without a walking aid.
  • Patients own and know how to operate a smart phone or tablet.
  • Patients are willing and able to complete the activity monitoring.
  • Patients are self-reportedly underactive.


Exclusion Criteria:
 

  • Patients are < 1 year postmenopausal.
  • Patients require a walking aid for daily mobility.
  • Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
  • Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
  • Patients are unable or unwilling to complete activity monitoring.
  • Patients are unable to provide informed consent independently.

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

Behavioral, Device
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Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans

A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics

Adrian Vella
All
18 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
2020-300238-P01-RST
20-003984
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Inclusion Criteria:

  • 40 nondiabetic subjects will be recruited.  
  • After approval from the Mayo Clinic Institutional Review Board, the Mayo Clinic Biobank will genotype individuals at rs3765467:
    • recruit subjects so that 20 will have the AA genotype at rs3765467;
    • remainder will have the GG genotype.
  • Individuals encompassing the age span of 25-65 years.


Exclusion Criteria:

  • Individuals under 25 and over 65 years of age.
Biologic/Vaccine, Other
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Autosomal Dominant Hypocalcemia Types 1 and 2 (ADH1/2) Disease Monitoring Study (DMS) (CLARIFY)

CLARIFY: ADH1 and ADH2 Disease Monitoring Study (DMS)

Peter Tebben
All
up to 90 years old
This study is NOT accepting healthy volunteers
2021-306497-P01-RST
21-012116
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Inclusion Criteria:

  • Patients age 1 year through adult.
  • Have a documented activating variant of the CASR gene for ADH1 or documented activating variant of the GNA11 gene for ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment.
    • Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
  • Be willing and able to provide informed consent or assent after the nature of the study has been explained, and prior to any research-related procedures.
  • Be willing to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available.
  • Be willing and able to comply with the study visit schedule and study procedures.


Exclusion Criteria:

  • Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures.
  • Enrollment in an ADH1/2 interventional clinical study at the time of DMS Screening visit or at any point during the DMS.

Eligibility last updated 3/30/23. Questions regarding updates should be directed to the study team contact.

Autosomal dominant hypocalcemia
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MAGNETIC RESONANCE SPECTROSCOPY BIOMARKERS IN TYPE 3 GAUCHER DISEASE (GD3)

All
18 Years to 80 Years old
This study is NOT accepting healthy volunteers
NCT05586243
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Inclusion Criteria:

• All participants must be 18 years or older.
• All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
• Individuals with GD3 who are medically stable for participation in study in the opinion of the investigator.
Exclusion Criteria:

• Medically unstable conditions as determined by the investigators.
• Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.
• Women who are pregnant or lactating or of child-bearing age that are not using acceptable forms of contraception.
• Patients enrolled in another interventional study.
• Patients who cannot or are unwilling to have blood drawn.
• Inability to undergo Magnetic Resonance Imaging (MRI) scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.
• Unable to adhere to study protocol for whatever reason.
Other: No intervention
Gaucher Disease, Type 3
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University of Minnesota — Minneapolis, Minnesota Reena V. Kartha, Ph.D - (rvkartha@umn.edu)

Understanding Pediatric Physical Therapists’ Experiences Working With Middle Eastern Patients and Families Who Require Arabic Interpreter Services: A Qualitative Study

A Qualitative Study of Understanding Pediatric Physical Therapists’ Experiences Working With Middle Eastern Patients and Families Who Require Arabic Interpreter Services

Natalie Woodberry
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302932-H01-RST
20-012391
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Inclusion Criteria:

  • Have worked in the outpatient PPT setting at Mayo Clinic within the last 8 years (5 years for recent recall, plus 3 years to account for decreased patient population of interest during Covid-19 pandemic).
  • Have worked with at least 1 Arabic speaking patient/family with interpreter services.
  • Report ability to discuss experience with this patient population.


Exclusion Criteria:

  • Have not met inclusion criteria.

Eligibility last updated 10/17/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity

Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity

Emily Sharpe
Female
up to 50 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-119226-H01-RST
16-009567
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Inclusion Criteria:

  • ASA physical status II-III women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia
  • Singleton gestation at term (37-42 weeks)
  • Female, age 18-50 years old.


Exclusion Criteria:

  • Preexisting diabetes (Gestational diabetes, Type I DM, Type II DM).
  • Taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism.
  • Kidney, heart, or liver disease. Severe lipid disorders.
  • History of bariatric surgery.
  • Pre-pregnancy BMI > 40.
  • Prolonged period of time (>4 hours) between ingestion of carbohydrate drink and surgery.
  • Four or more repeat cesarean sections.
Dietary Supplement, Elective cesarean section, Preoperative procedure
C-section, Delivery by elective cesarean section, Drug resistance to insulin
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Mayo Clinic — Rochester, MN

An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity (CARE PAH)

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

Hilary DuBrock
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
2021-305513-P01-RST
21-008200
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Inclusion Criteria:


- Symptomatic pulmonary arterial hypertension (PAH) in any PAH subtype

- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to or at
the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure
greater than (>) 20 millimeters of mercury (mm Hg), and b) Pulmonary artery wedge
pressure or left ventricular end diastolic pressure less than or equal to (<=) 15 mm
Hg, and c) Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units
(that is, >= 240 dynes seconds per centimeters penta [dyn?sec/cm^5])

- Participant satisfies either a or b: a) Newly initiating 1 or more PAH therapy(ies)
(as monotherapy or add-on therapy) at index date. These newly initiated PAH therapies
should not have been used within 3 months of the index date; b) Taking macitentan 10
milligrams (mg) therapy (as monotherapy or in combination) with no changes in PAH
therapy for within 3 months prior to the index date

- All mandated assessments must be performed and recorded at the baseline visit before
the initiation of the new PAH therapy at the index date or enrollment in the study.

- For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy
only: Participants initiating any endothelin receptor antagonist (ERA) or
phosphodiesterase-5 inhibitor therapies at index date or at therapy change must
provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give
consent for the optional PAH-SYMPACT substudy will not exclude a participant from
participation in the main study


Exclusion Criteria:


- Participants enrolled in any interventional clinical trial with an investigational
therapy in the 3-month period prior to index date

- Currently enrolled in an observational study sponsored or managed by a Janssen company

- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] <70%; and FEV1 <60% of predicted after
bronchodilator administration) in participants with a known or suspected history of
significant lung disease, as documented by a spirometry test performed within 1 year
prior to screening

- Presence of moderate or severe restrictive lung disease (for example, total lung
capacity or FVC <60 percent [%] of normal predicted value) in participants with a
known or suspected history of significant lung disease, as documented by a spirometry
test performed within 1 year prior to screening

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

Eligibility last updated 7/27/22.  Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

Outcomes of Treatment with Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study (VNS-PoCoS)

Vagal Nerve Stimulation for Post-COVID Fatigue

Ravindra Ganesh
All
18 years and over
Not Applicable, Post Market
This study is NOT accepting healthy volunteers
2022-307072-H01-RST
22-000925
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Presence of fatigue and post exertional malaise.
  • Presence of headache
  • Clinical diagnosis of post COVID syndrome.
  • They have consented to participate in the study
  • They have the ability to participate in all aspects of the study.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Pregnant.
  • Prior adverse reaction to 14FDG.
  • Active implantable medical device e.g. pacemaker, hearing aid implant
  • Metallic device e.g. stent, orthopedic hardware in neck
  • Using another electronic device at the same time e.g. TENS, mobile phone. 
  • Any other condition deemed exclusionary by the study principal investigator

Eligibility last updated 1/26/22. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination

Assessing the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination

Alessandra Ainsworth
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308488-H01-RST
22-006147
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Inclusion Criteria:

  • 18 years of age or older undergoing an IUI procedure.
  • IUI must be performed in the offices at Mayo Clinic in Rochester, MN or Eau Claire, WI.
  • IUI procedure must be on a weekday.
  • IUI procedure is scheduled to be completed by a nurse.


Exclusion Criteria:
 

  • Non-English speaking.
  • IUI procedure on a weekend day.
  • IUI procedure is scheduled with an MD provider (known or expected to be difficult).
  • Planned IUI procedure is cancelled prior to undergoing the procedure.
  • The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
  • The patient has previous participated or declined enrollment in the study during a prior IUI procedure.

Eligibility last updated 6/14/23. Questions regarding updates should be directed to the study team contact.

 

Intrauterine artificial insemination, Music therapy, Behavioral, Other
Anxiety disorder
Anxiety about treatment, Anxiety disorder, Intrauterine insemination
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A Phase 3, Multicenter, Prospective, Randomized, Double-blind, Efficacy and Safety Study of Rezafungin for Injection Versus the Standard Antimicrobial Regimen for the Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)

Paschalis Vergidis
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306121-P01-RST
21-012795
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Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Males or females, ≥ 18 years of age.
  • Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  • Diagnosed with 1 of the following underlying diseases:
    • Refractory anemia;
    • Refractory anemia with ringed sideroblasts;
    • Refractory cytopenia with multilineage dysplasia;
    • Refractory cytopenia with multilineage dysplasia and ringed sideroblasts;
    • Refractory anemia with excess blasts
      •1 (5-10% blasts);
    • Refractory anemia with excess blasts
      •2 (10-20% blasts);
    • Myelodysplastic syndrome, unclassified;
    • Myelodysplastic syndrome associated with isolated del (5q);
    • Chronic myelomonocytic leukemia;
    • Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant;
    • Aplastic anemia;
    • Primary or secondary myelofibrosis.
  • Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
  • Acute lymphoblastic leukemia, in first or second complete remission.
  • Acute undifferentiated leukemia in first or second remission.
  • Acute biphenotypic leukemia in first or second complete remission.
  • Chronic myelogenous leukemia in either chronic or accelerated phase.
  • One of the following myelodysplastic syndrome(s) defined by the following:
    • Receiving myeloablative or reduced-intensity conditioning regimens.
  • Adequate renal and hepatic function, within 6 weeks of initiation of conditioning, as measured by:
    • Hepatic (within 72 hours of Day 0): alanine aminotransferase;
    • Renal (within 72 hours of Day 0): Serum creatinine within normal range for age or if serum creatinine above ULN range for age, a creatinine clearance [CrCl]) ≥60 mL/min.;
    • Baseline blood samples drawn for serum Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 14 days before randomization, with results available prior to randomization;
    • Baseline Toxoplasma serologies available within 6 weeks prior to randomization;
    • Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency testing with no evidence of G6PD deficiency performed within 6 weeks prior to randomization.
  • Female subjects of child-bearing potential < 2 years post-menopausal must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.


Exclusion Criteria:

  • Diagnosis of AML not in morphological remission.
  • Diagnosis of chemotherapy-resistant lymphoma.
  • Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening.
  • Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤ 40%, LVEF > 40% but fails to improve with exercise, or shortening fraction ≤ 26%.
  • Personal or family history of Long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected (QTc) interval (> 470 msec in males and > 480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, or quinidine.
  • Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin), forced expiratory volume 1, forced vital capacity ≤ 45% of predicted value, or O2 saturation ≤ 85% on room air.
  • Suspected or documented PCP within 2 years of screening.
  • Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (≥ 80 pg/mL).
  • Receipt of previous allogeneic BMT.
  • Planned receipt of cord blood for transplantation.
  • Planned peripheral blood or marrow autograft.
  • Underlying diagnosis of multiple myeloma.
  • Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per NCI CTCAE version 5.0.
  • History of severe ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease).
  • Planned or ongoing therapy at screening with a known neurotoxic medication for a complete list of prohibited neurotoxic medications).
  • Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
  • Known hypersensitivity or inability to receive TMP/SMX or any of its excipients.
  • Recent use of an investigational medicinal product within 28 days of the first dose of prophylactic study drug or presence of an investigational device at the time of screening.
  • Known infection with HIV.
  • Pregnant or lactating females.
  • The Principal Investigator (PI) determines that the subject should not participate in the study.
  • Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).

Eligibility last updated 10/5/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Development of NGS (next generation sequencing) based circulating tumor DNA (ctDNA) assays for oncology patients with solid tumors

Circulating Tumor DNA (cTDNA) Based in NGS (Next Generation Sequencing) Assays for Oncology Patients With Solid Tumors

Gang Zheng
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308976-H01-RST
22-007752
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Inclusion Criteria:

  • Patients seen in Oncology or surgery with a diagnosis of a solid tumor malignancy,.


Exclusion Criteria:
  

  • < 18 years of age. 

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

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An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

A Study to Evaluate the Effectiveness and Safety of DA-1229 (Evogliptin) in Delaying Progression of Mild or Moderate Calcific Aortic Stenosis (EVOID-AS trial)

Ratnasari Padang
All
35 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-306606-P01-RST
21-012772
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Inclusion Criteria:


1. Male or female adult ≥ 35 years of age at time of screening.

2. Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by:

- Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Are ≥ 1.2 and ≤ 2.0 cm^2 on TTE within 2 weeks prior
to randomization and,

- Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization

3. Subject provides written informed consent prior to initiation of any study procedures.

4. Subject understands and agrees to comply with planned study procedures.


Exclusion Criteria:


1. Subject has concomitant moderate or more aortic valve regurgitation.

2. Subject has concomitant moderate or severe mitral or tricuspid valve disease.

3. Subjects has left ventricular ejection fraction < 50%.

4. Subject previous history of aortic valve surgery.

5. Subject has NYHA class III or IV heart failure.

6. Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range.

7. Subjects who cannot undergo Cardiac CT.

8. Subjects whose life expectancy is < 2 years.

9. Subjects with ESRD (End-stage Renal Disease) defined as eGFR (calculated using MDRD equation) ≤ 30 mL/min/1.73m^2 or in need of dialysis.

10. Subject has diabetes mellitus.

11. Subject has history of pancreatitis.

12. Subjects who are currently taking or anticipated to take any of the following medications for the duration of the study:

- Insulin, DPP4 inhibitor, oral hypoglycemic agent

- Vitamin K

- Any medications that impact hepatic metabolism, giving rise to drug-drug interaction (with the exception of focal treatment) CYP3A4 inducer: barbiturates, rifampicin, carbamazepine, phenytoin

13. Subjects with history of severe allergic reaction to DPP4 inhibitors including anaphylaxis and angioedema

14. Subjects with galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption

15. Subjects with history of severe cerebrovascular diseases (such as cerebral infarction or transient ischemic attack), severe cardiovascular diseases (such as unstable angina, myocardial infarction and life-threatening arrhythmia) within 6 months of screening.

16. Subjects with history of malignant tumor within the past 3 years prior to Screening Visit (Visit 1) unless cure is expected.

17. Subjects with history of drug or alcohol abuse. History of cannabis/Marijuana use including recreational use in the last 6 months and an unwillingness to abstain during the course of the study.

o Note: Alcohol abuse is a pattern of drinking that result in harm to one's health, interpersonal relationships, or ability to work. Manifestations of alcohol abuse include the following: Failure to fulfill major responsibilities at work, school, or
home, drinking in dangerous situations, such as drinking while driving or operating machinery, legal problems related to alcohol, such as being arrested for drinking while driving or for physically hurting someone while drunk and continued drinking despite ongoing relationship problems that are caused or worsened by drinking

18. Subjects with history of medication non-compliance

19. Pregnant or lactating women

20. Subjects who used investigational drugs or devices within 4 weeks or investigational biologics within the last 6 months prior to screening and for the duration of the study.

21. Inability to provide informed consent or to comply with test requirements

22. Subjects with physical (severe hepatic, cardiac, renal, pulmonary, hematological,
endocrine, gastrointestinal, etc. conditions) or mental (cognitive, psychiatric, etc. conditions) conditions that may impact their ability to take part in the study.

23. Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment

24. . Women of child-bearing age who are sexually active but decline to take proper contraceptive measures during the study period, unless the female is post-menopausal for at least 2 years or are surgically sterile.

- Note: Women of childbearing potential (WOCBP) and Women not of childbearing potential are eligible to participate. Women of childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of investigational product). o Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners of WOCBP must agree to consistently and correctly use a condom for the duration of the study and for 30 days after taking the study drug. In addition, subjects may not donate ova or donate sperm for the duration of the study and for 30 days after taking the last dose investigational product.

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

Eligibility last updated 12/29/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Saad Kenderian
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306884-P01-RST
22-000405
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Inclusion Criteria:

  • The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable.
  • The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
  • In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.


Exclusion Criteria:

  • None.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Assessing the Utility of Disc Space Aspirate Cell Count and Differential in the Diagnosis of Native Vertebral Osteomyelitis

Diagnosis of Native Vertebral Osteomyelitis by Assessing the Utility of Disc Space Aspirate Cell Count and Differential

Elie Berbari
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308313-H01-RST
22-005791
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Inclusion Criteria:

  • Patients 18 years of age or older.
  • Referred to the neuroradiology department for diagnostic image guided biopsy.
  • The reason for image-guided biopsy would either be due to suspicion for NVO or for other reasons such as ruling out malignancy.


Exclusion Criteria:

  • Patients less than 18 years of age.
  • Patients with spinal hardware / instrumentation.
  • Post operative patients.
  • Patients unable to provide consent.

Eligibility last updated 6/1/22. Questions regarding updates should be directed to the study team contact.

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Managing Multiple Seizure Types with Wearable Devices

Development of a Practical, Minimally Invasive Seizure Gauge

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

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


Exclusion Criteria:

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

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

 

Device
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A Pilot Trial of Baked Milk Introduction in Patients with Milk-triggered Eosinophilic Esophagitis

Eosinophilic Esophagitis Pilot Trial of Baked Milk Tolerance

Karthik Ravi
All
18 years to 90 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-308989-H01-RST
22-007941
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Inclusion Criteria:

  • 18 to 90 years of age
  • Diagnosed with Eosinophilic esophagitis ≥ 15 eosinophils per HPF
  • Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger


Exclusion Criteria:

  • Patients with conditions known to be associated with esophageal eosinophilia, including Crohn’s disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
  • Topical swallowed steroids within 8 weeks of study enrollment
  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

 

Other
Eosinophilic esophagitis, Esophagitis
Digestive system, Elimination diet, Eosinophilic esophagitis, Intolerance to milk
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A Phase 2, Randomized, Open-Label, 24-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participants with PMM2-CDG

24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Adults With PMM2-CDG

Marc Patterson
All
18 years to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-309245-P01-RST
22-008910
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Inclusion Criteria:


- Is a male or female, 18 to 65 years of age, inclusive, at Screening;

- Has been diagnosed with PMM2-CDG with genetic test confirmation;

- Has antithrombin III (ATIII) levels below 80%;

- If the participant is a female of childbearing potential, she must not be pregnant (confirmed by a negative serum pregnancy test), is using a medically accepted method
of contraception (abstinence, a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use of an intrauterine device), and must agree to continue using this method for 30 days after the last infusion of GLM101;

- If the participant is a female of non-childbearing potential, she must be pre-pubertal, surgically sterile, or must have an ovarian dysfunction confirmed by a follicle stimulating hormone > 40 IU/L;

- If the participant is a sexually active male with female partners, the sexually mature, nonsterile male participant agrees to use a medically acceptable method of
contraception (abstinence, the partner taking a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use by the partner of an intrauterine
device) and agrees to continue using this method for 30 days after the last infusion of GLM101. Males are considered surgically sterile if they have undergone bilateral
orchiectomy or vasectomy at least 3 months prior to Screening;

- If the participant is male, he must agree to refrain from donating sperm during the study and 30 days after the last infusion of GLM101;

- Is willing and able to provide informed consent/assent, directly or through his/her legally authorized representative.


Exclusion Criteria:


- Diagnosis of congenital disorder of glycosylation (CDG) other than PMM2;

- Has an active infection requiring parenteral antibiotics, antivirals, or antifungals or treatment with systemic steroids within 7 days prior to Screening;

- Has confirmed active coronavirus disease-2019 (COVID-19) infection or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or check in to clinical site;

- Has a history of a severe allergic reaction to any drug or excipients of GLM101 (as listed in the GLM101 Investigator's Brochure);

- Has a known history of poor venous access;

- Has a history of liver transplant;

- Has a history of drug or alcohol use disorder within 12 months from Screening;

- Has had a major surgical procedure within 30 days prior to Screening;

- Has Screening or eligibility confirmation laboratory value(s) outside the laboratory reference range considered clinically significant and not related to PMM2-CDG;

- If female, has a positive serum pregnancy test during Screening;

- Has serology positive for hepatitis B surface antigen or hepatitis C antibody during Screening;

- Has history or presence, upon clinical evaluation, of any illness that might impact the safety of GLM101 infusion or evaluability of drug effect based on the Principal
Investigator's and Medical Monitor's discretion;

- Is currently participating in another interventional clinical study or has completed another clinical study with an investigational drug or device within 30 days or 5
half-lives before GLM101 infusion, except for acetazolamide. Participants may be enrolled and continue treatment with acetazolamide only if they are on a stable dose for at least 30 days prior to dosing with GLM101, and the dose remains unchanged for the duration of the study.

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

Eligibility last updated 9/15/23. Questions regarding updates should be directed to the study team contact.

Drug
Congenital disorder of glycosylation type Ia
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Arimoclomol Prospective Doubleblind, Randomised, Placebo-controlled Study in Patients Diagnosed With NiemannPick Disease Type C (Arimoclomol)

Arimoclomol Prospective Study in Patients Diagnosed With NiemannPick Disease Type C

Marc Patterson
All
6 months to 18 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-118864-P01-RST
16-006394
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Inclusion Criteria:

  • EITHER NP-C patients who have entered the CTORZYNPC001 study and who have completed Visit 2 (EOS) of the CTORZYNPC001 study.

OR

  • NPC patients who did not enter or complete the CTORZYNPC001 study but are fulfilling all of criteria listed below:
    • Diagnosis of NPC1 or NPC2;
    • NPC diagnosis confirmed by:
      • Genetically confirmed (deoxyribonucleic acid [DNA] sequence analysis) by mutations in both alleles of NPC1 or NPC2, OR
      • Mutation in only one allele of NPC1 or NPC2 plus either positive filipin staining or elevated cholestane triol/oxysterols (>2 x upper limit of normal).
    • Males and females aged from 2 years to 18 years and 11 months;
    • Treated or not treated with miglustat;
    • If a patient is under prescribed treatment with miglustat, it has to be under stable dose of the medication for at least 6 continuous months prior to inclusion in the CTORZYNPC002 study;
    • If a patient has been discontinued from prescribed treatment with miglustat, they must have been discontinued for at least 3 continuous months prior to inclusion in the CT-ORZY-NPC-002 study;
    • Body mass index (BMI) Z score ≥ -2 SD (standard deviation) for age, according to the World Health Organisation (WHO) standards;
    • Presenting at least one neurological symptom of the disease (for example, but not limited to, hearing loss, vertical supranuclear gaze palsy, ataxia, dementia, dystonia, seizures, dysarthria, or dysphagia);
    • Ability to walk either independently or with assistance.
  • Written informed consent (and assent if appropriate to local laws and regulations) prior to any study-related procedures;
  • Willing to participate in all aspects of trial design including blood sampling (PK, blood biomarkers and safety labs), skin biopsies and imaging (ultrasonography of the liver and spleen);
  • Ability to travel to the corresponding clinical trial site at the scheduled visit times for evaluation and follow-up;
  • All sexually active female patients of child-bearing potential (post-menarchal) must use highly effective contraception during the study and until 1 week after the last dose of IMP.
  • Highly effective birth control methods include: Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; and vasectomised partner.
  • All sexually active male patients with female partners of child-bearing potential (post-menarchal) must use a condom with or without spermicide in addition to the birth control used by their partners during the study and until 3 months after the last dose of IMP.

Sexual abstinence is considered a highly effective birth control method only if it is defined as refraining from heterosexual intercourse during the study and for 1 week after the last dose of IMP (for female patients of child-bearing potential) and for 3 months after the last dose of IMP (for male patients with female partners of child-bearing potential). The reliability of sexual abstinence needs to be evaluated by the Investigator in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.

  • Ability to comply with the protocol-specified procedures/evaluations and scheduled visits.


Exclusion Criteria:

  • Recipient of a liver transplant or planned liver transplantation;
  • Severe liver insufficiency (defined as hepatic laboratory parameters, AST and/or ALT greater than three-times the upper limit of normal for age and gender (central laboratory assessment);
  • Renal insufficiency, with serum creatinine level greater than 1.5 times the upper limit of normal (central laboratory assessment);
  • Known or suspected allergy or intolerance to the IMP (arimoclomol or constituents);
  • In the opinion of the Investigator, the patient's clinical condition does not allow for the required blood collection and/or skin biopsies as per the protocol-specified procedures;
  • Treatment with any investigational drug during the study or in the 4 weeks prior to entering the study.

This includes treatment with any investigational drug during the study in an attempt to treat NP-C;

  • Pregnancy or breastfeeding;
  • Current participation in another trial is not permitted unless it is a non-interventional study and the sole purpose of the trial is for long-term follow up/survival data (registry);
  • For patients who have not completed the CTORZYNPC001 study, fulfilling any of the criteria listed below:
    • Patients with uncontrolled severe epileptic seizures period (at least 3 consecutive severe epileptic seizures that required medication) within 2 months prior to the written consent. This includes patients with ongoing seizures that are not stable in frequency or type or duration over a 2 month period prior to enrolment, requiring change in dose of antiepileptic medication (other than adjustment for weight) over a 2 month period prior to enrolment, or requiring 3 or more antiepileptic medications to control seizures;
    • Neurologically asymptomatic patients;
    • Severe manifestations of NP-C disease that would interfere with the patient's ability to comply with the requirements of this protocol;
    • Treatment with any IMP within 4 weeks prior to the study enrolment.
Drug, Drug therapy
Congenital metabolic disorder, Leukodystrophy, Niemann-Pick disease
Niemann-Pick disease, type C, miglustat
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) (SCN8A-DEE)

Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Lily Wong-Kisiel
All
2 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305257-P01-RST
21-009966
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Inclusion Criteria:

  • Written or oral pediatric assent from the subject if deemed capable of providing assent, and written informed consent from the subject’s parent(s) or legal guardian(s) for subjects < 18 years of age and for subjects ≥ 18 years of age who are not capable of providing consent in accordance with the governing Independent Ethics Committees (IEC)/Institutional Review Boards (IRB) and according to local laws and regulations. Subjects who are ≥ 18 years of age and capable of providing consent should sign an Informed Consent Form (ICF). Informed consent/assent may be done remotely, if allowed and remote consenting procedures are in place.
  • Be a male or female 2 to 21 years of age, inclusive.
  • Have a diagnosis of SCN8A-DEE supported by both clinical and genetic findings outlined as follows:
  • Clinical findings
    •required:
    • Seizure onset prior to 18 months of age;
    • Developmental delay which may have occurred either prior to or with onset of seizures or after.
  • Supportive (not required):
    • Multiple seizure types which include focal seizures (including focal to bilateral tonic-clonic), tonic-clonic seizures, epileptic/infantile spasms, tonic seizures;
    • History or ongoing motor abnormalities including hypotonia, dystonia, choreoathetosis, ataxia, spasticity, hyperekplexia;
    • Episodes of convulsive and nonconvulsive status epilepticus;
    • Beneficial response to sodium channel blockers such as phenytoin, valproate, carbamazepine, lacosamide, lamotrigine, rufinamide, and oxcarbazepine.
  • Genetic findings (both required):
    • Pathological gain of function (GOF) mutation in SCN8A defined as either a previously identified GOF mutation or a presumed pathological GOF mutation. Presumed pathological GOF mutations must be either a missense mutation that is not seen in either parent (de novo) OR a mutation which leads to a hyperfunctioning channel in in vitro function tests. Presumed pathological GOF mutations must not be nonsense mutations or other mutations likely to lead to a truncated protein;
    • No other pathogenic mutation in an additional gene that is known to cause epilepsy and is more likely to cause the epilepsy experienced by the subject.  

Genetic findings required for SCN8A-DEE diagnosis may be based on genetic testing performed previously. The genetic mutation in the subject’s SCN8A gene (b[i]) and the absence of other pathogenic mutations that are more likely to cause the epilepsy experienced by the subject (b[ii]) must be confirmed at screening as part of the comprehensive epilepsy panel genotyping.

  • Have SCN8A-DEE diagnosis confirmed by the DCP.
  • In the 90 days before screening, have a history of on average at least 4 countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per month.
  • Have on average at least 1 countable motor seizure (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per week (4 per 28-day period) and not be seizure-free for more than 20 consecutive days per 28-day period during the baseline period.
  • Have at least 4 weeks of reliably and consistently completed baseline seizure diary data.
  • Being treated with at least 1 other ASM, but no more than 4 ASMs. Epidiolex®/Epidyolex® will be considered an ASM. The dose should be stable for at least 5 half-lives at screening. Vagus nerve stimulator (VNS) and ketogenic diet are not counted as ASMs.
  • Have failed to achieve seizure freedom with at least 2 ASMs.
  • The subject, if using a VNS, must have had the VNS placed at least 3 months prior to screening with stable settings for ≥ 30 days before screening; settings must remain stable throughout the duration of the study.
  • The subject, if on a ketogenic diet, must have started the ketogenic diet at least 30 days prior to screening; diet must be stable, and continue through the duration of the study.
  • Must be using a nocturnal alerting system or practice consistent with standards of care at the time of screening and continue to use this for the duration of the study. Acceptable nocturnal alerting systems or practices include but are not limited to:
    • Parent/caregiver sleeps in the same room as subject;
    • Video- and/or acoustic-based monitoring (e.g., use of baby monitor);
    • Device intended as a seizure alert system (e.g., bracelet devices).
  • Must have an adequate rescue medication regimen per the investigator’s judgment in place at the time of screening and for the duration of the study.
  • Female subjects of childbearing potential must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.

A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (ie, menarche) and are not surgically sterile (ie, bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening). A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening.

  • Highly effective methods of contraception are required for female subjects of childbearing potential:
    • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS);
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (which may be oral, intravaginal, or transdermal) initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Bilateral tubal ligation;
    • Total abstinence from sexual intercourse (periodic abstinence is not acceptable);
    • Sexual partner(s) who had been vasectomized at least 3 months prior to screening with medically confirmed successful procedure;

Male subjects must agree to use effective barrier contraception consistently from screening until 30 days after the last dose of study treatment. The acceptable method of contraception for male subjects is condom with spermicide (cream, spray, foam, gel, suppository, or polymer film).

  • Have a body weight of at least 10 kg.
  • Be able to carry out all the appropriate assessments and take the study treatment with the help of the parent/caregiver in the opinion of the investigator.
  • Te subject’s parent/caregiver is able to accurately identify seizure types, especially countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) and is able to complete seizure diary.


Exclusion Criteria:

  • Have previously been enrolled in this study and received blinded treatment.
  • Have participated in an interventional clinical trial <30 days prior to screening.
  • Have symptoms that would be more consistent with another epilepsy disorder such as Dravet syndrome (e.g., fever-induced episodes of status epilepticus, frequent myoclonic seizures, worsening on sodium channel blockers).
  • Are currently receiving cannabinoids or medical marijuana except Epidiolex/Epidyolex, unless approved by the Sponsor.
  • Are currently taking systemic steroids (excluding inhaled medication for asthma treatments) such as adrenocorticotropin hormone (ACTH), high dose prednisolone for epileptic spasms.
  • If subject has received these medications in the past, must be off these medications for at least 3 months prior to the screening visit and these drugs may not be initiated during the duration of the study. Intermittent steroids to treat nonepilepsy related diseases (such as allergies or dermatological conditions) are not exclusionary.
  • Are taking strong CYP3A4 inhibitor (e.g., ketoconazole, erythromycin, ritonavir) or inducer (e.g., rifabutin, rifampin, St. John's Wort) other than concurrent ASMs.
  • Have a history of severe drug allergy or hypersensitivity to NBI-921352 or its excipients.
  • Have a previous exposure to NBI-921352.
  • Have any other disorder for which the treatment takes priority over treatment of SCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.
  • Have a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator’s opinion, likely to affect nervous system functioning.
  • Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
  • Are taking or have received disallowed concomitant medication or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study.
  • Have clinically significant abnormal vital signs at the screening visit as determined by the investigator.
  • Have one or more clinical laboratory test values outside the reference range, based on blood samples taken at the screening visit, that are of potential risk to the subject’s safety as determined by the investigator, or have at the screening visit:
    • A serum creatine value > 1.5 times the upper limit of the reference range;
    • A total bilirubin value > 1.5 times the upper limit of the reference range;
    • A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2.5 times the upper limit of the reference range. For subjects on valproate, ALT or AST values up to 3 times the upper limit of the reference range are acceptable, if these values have remained stable over the past 3 months based on investigator judgement.
  • Have, at the screening visit, an ECG finding of a corrected QT interval using Fridericia’s formula (QTcF) > 450 msec or presence of any significant cardiac abnormality.
  • The subject or subject’s parent/caregiver, in the investigator’s opinion, is unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.
  • Have attempted suicide within the last year or are at significant risk of suicide (either in the opinion of the investigator or defined as a “yes” to suicidal ideation questions 4 or 5 or “yes” to suicidal behavior on the C-SSRS within the past 12-months).
  • Females who are pregnant or currently breastfeeding.
  • Have a history of a positive hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV-Ab) test results at screening. Subject with positive hepatitis C antibody (HCV-Ab) and confirmatory positive polymerase chain reaction (PCR) reflex test results at screening will be allowed to participate in the study provided that the subject is asymptomatic as assessed by the investigator and does not have exclusionary liver function test abnormalities (ALT, AST, and total bilirubin).
  • Have ingested grapefruit juice or grapefruit products within a 7-day period before Day -1.
Drug, Drug therapy
Encephalopathy, Epilepsy, Grand mal seizure, Seizure
NBI-921352, Nervous system, SCN8A-related epilepsy with encephalopathy, Zandatrigine
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A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3)

A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

Manal Abdelmalek
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305557-P01-RST
21-008365
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Prescreening Criteria:

- Diagnosed with NASH on prior liver biopsy

- Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on
ultrasound

- At least 3 of the components of metabolic syndrome

Inclusion Criteria:


1. Male or female, aged ≥18 years at the time of signing informed consent

2. Upon central biopsy reading process: diagnosis of NASH according to the
Steatosis-Activity-Fibrosis (SAF):

1. Steatosis score ≥1

2. Activity score: A3 or A4

3. Fibrosis score: F2 or F3

3. No qualitative change in dose for the drugs listed below:

1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1
receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2
inhibitors): for at least 3 months

2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months

3. Statins: for at least 3 months

4. No qualitative change in dose for all other chronically administered drugs for at
least 3 months prior to Screening

5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy
and Baseline (no more than 5% change for both periods)

6. Negative serum pregnancy test at study Screening for females of childbearing potential
confirmed by central laboratory. Females of childbearing potential must practice a
consistent and proper use of highly effective method of contraception throughout the
study and for 1 month after treatment discontinuation.


Exclusion Criteria:


Liver-related:

1. Documented causes of chronic liver disease other than NASH

2. Histologically documented liver cirrhosis (fibrosis stage F4)

3. History or current diagnosis of hepatocellular carcinoma (HCC)

4. History of or planned liver transplant

5. Positive human immunodeficiency virus (HIV) serology

6. ALT or AST >5 × ULN

7. AST<0.6 ULN if the liver biopsy has to be performed in the scope of the study

8. Abnormal synthetic liver function as defined by Screening central laboratory
evaluation

9. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males

10. Patient currently receiving any approved treatment for NASH or obesity

11. Current or recent history (<5 years) of significant alcohol consumption

12. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD)
administered for at least 2 weeks within 12 months prior to qualifying liver biopsy

Glycaemia related:

13. HbA1c >9% at Screening

14. Diabetes mellitus other than type 2

15. Current treatment with insulin

16. Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months before
screening or historical biopsy.

Obesity related:

17. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to
the qualifying liver biopsy; malabsorptive procedures and procedures combining both
restrictive and malabsorptive methods are not allowed within 5 years of the qualifying
liver biopsy.

Cardiovascular related:

18. History of heart failure with reduced left ventricular ejection fraction (LVEF)

19. Atrial fibrillation requiring anticoagulation

20. Unstable heart failure

21. Uncontrolled hypertension at Screening (values >160/100 mm Hg)

General safety:

22. Women currently breastfeeding

23. Previous exposure to lanifibranor

24. Participation in any clinical trial investigational medicinal product/device within 3
months from Screening or 5 half-lives from Screening, whichever is longer

25. Concomitant treatment with PPAR-alpha agonists (fibrates)

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

Eligibility last updated 11/22/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR) (AMSCAR)

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Timucin Taner
All
18 years to 70 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-306557-H01-RST
21-012522
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Inclusion Criteria:


- Able to understand and provide informed consent.

- Have received a renal transplant (first or repeat), and the most recent protocol
biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.

Clinical
Inclusion Criteria:


- Stable renal function:

- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the
serum creatine prior to the biopsy (must be within 3 months of the biopsy);

- Estimated eGFR > 30 ml/min by MDRD.

Histologic Criteria for Eligibility:

- ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular
capillaritis (ptc) (g:1 or 2; ptc:1 or 2).

- Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2);
intimal arteritis (v) (v: 1 or 2).

- Mixed ABMR and cellular rejection.


Exclusion Criteria:


- Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year
preceding screening.

- History of post-transplant intervention for obstructive uropathy

- One or more of the following laboratory values:

o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT)
≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0,
Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase
their platelet count will not be excluded).

- One or more of the following parameters:

o Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤
90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or >
140/min

- Patients with the following grades/classes of vascular diseases:

- NYHA Class 3-4 CHF

- Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular
response, supraventricular tachycardia, Wolff-Parkinson-White syndrome,
ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled
chronic atrial fibrillation will be allowed to participate.

- Cerebrovascular accident (CVA) within 90 days of screening

- Peripheral Arterial Disease (PAD), patients who have had prior vascular
interventions for PAD in the index lower extremity.

- Acute illness within 30 days of screening.

- History of allergy or intolerance to iodinated contrast agents

- Women of childbearing potential or male subjects with female partners of childbearing
potential unwilling to use an effective method of contraception during and for 12
months post-treatment.

- History of or current evidence of alcohol abuse, illicit drug use or dependence

- Active COVID 19 or positive test for the SARS-CoV-2 virus

- History of malignancy within 5 years of enrollment. History of adequately treated
in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous
cell) will be permitted

- Serologic evidence of human immunodeficiency virus 1 or 2 infection

- Epstein Barr Virus (EBV) sero-negativity (EBV naïve)

- Cytomegalovirus (CMV) sero-negativity

- Active post-transplant opportunistic infections at the time of screening (CMV, BK
virus, polyoma virus, EBV)

- Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core
antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV
IgG positive), or those with HBV surface antibody positive but HBV core antibody
negative subjects will not be excluded from the study.

- Have received a kidney transplant from a Hepatitis C positive donor and plan to
receive anti-viral treatment after transplant

- Any chronic condition for which anti-coagulation cannot be safely interrupted for
kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall
into either the high or the moderate thrombotic risk, they will be deemed to be not
safe to interrupt anticoagulation:

- High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any
caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months)
stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6,
CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic
attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within
3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or
antithrombin; antiphospholipid antibodies; multiple abnormalities)

- Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve
prosthesis and 1 or more of the of following risk factors: atrial fibrillation,
prior stroke or transient ischemic attack, hypertension, diabetes, congestive
heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6;
Venous thromboembolism: VTE within the past 3 to 12 months, non-severe
thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation),
recurrent VTE

- For all other subjects, anticoagulation can be safely interrupted for 3 days
prior to infusion and resumed a day after the infusion.

- Positive pregnancy test

- Participation in any other studies that involved investigational drugs or regimens in
the preceding year

- Any other condition, in the investigator's judgment, that increases the risk of A-MSC
infusion or prevents safe trial participation

- Unwilling or unable to adhere to study requirements and procedures

- Per Banff criteria category 6: the presence of other changes not considered to be
caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant
Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury,
Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or
Drug-Induced Interstitial Nephritis

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

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.

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

Preoperative Evaluation for Obstructive Sleep Apnea at Home

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

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


Exclusion Criteria:

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

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

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A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects with Glioblastoma Brain Tumors

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

Terence Burns
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307691-P01-RST
22-003261
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Inclusion Criteria:

  • Male or female.
  • Between > 18-80 years of age.
  • Able and willing to give informed consent 
  • Subjects with a suspected glioblastoma tumor on pre-operative brain imaging scans.
  • Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care.
  • Karnofsky Performance Score > 70.
  • Able to communicate sensations during the Exablate BBBD procedure.


Exclusion Criteria:

  • Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
  • Multifocal tumors.
  • MRI or clinical findings of:
    • Active or chronic infection(s) or inflammatory processes;
    • Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages;
    • Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis.
  • MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices.
  • Significant cardiac disease or unstable hemodynamic status:
    • Documented myocardial infarction within six months of enrollment;
    • Unstable angina on medication;
    • Unstable or worsening congestive heart failure;
    • Left ventricular ejection fraction below the lower limit of normal;
    • History of a hemodynamically unstable cardiac arrhythmia;
    • Cardiac pacemaker;
    • History of hypersensitivity to Perflutren lipid microsphere or its components; e.g., polyethylene glycol.
  • Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication).
  • Unable to discontinue use of anti-coagulant/antiplatelet therapy as per local standard.
  • History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding.
  • Abnormal coagulation profile (Platelets < 80,000), PT (> 14) or PTT (> 36), and INR > 1.3.
  • Known cerebral or systemic vasculopathy.
  • Significant depression and at potential risk of suicide.
  • Known sensitivity/allergy to gadolinium or DEFINITY®.
  •  Active seizures despite medication treatment (defined as > 1 seizure per week) which could be worsened by disruption of the blood brain barrier.
  • Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning.
  • Positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
  • Potential blood-borne infections which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.
  • Any contraindications to MRI scanning, including:
    • Large subjects not fitting comfortably into the scanner;
    • Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia.
  • Impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73m^2.
  • Severe Respiratory Illness: chronic pulmonary disorders; e.g.,severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, subjects with a history of severe drug allergies, asthma or hay fever, and multiple allergies where the benefit/risk of administering Definity® is considered unfavorable by the study physicians in relation to the product labeling for Definity®.
  • Currently in a clinical trial involving an investigational product or non-approved use of a drug or device.
  • Pregnancy or lactation.
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Mayo Clinic — Rochester, MN

Testing for Monoclonal Proteins by Blood Spot and Saliva

Monoclonal Proteins by Blood Spot and Saliva

David Murray
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307738-H01-RST
22-003158
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Inclusion Criteria:

  • Adult patients ≥ 18 years old.
  • Diagnosed with plasma cell disorders.


Exclusion Criteria:

  • Children < 18 years old.
  • Pregnant females.

Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.

I'm interested
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Location Contacts
Mayo Clinic — Rochester, MN