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MC198A, Phase I Dose Escalation Trial of CD19 Directed Chimeric Antigen Receptor T Cell Therapy in The Treatment of B Cell Malignancies

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/​Refractory B Cell Malignancies

Saad Kenderian
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101226-P01-RST
20-007714
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Inclusion Criteria:


- Age >= 18 years

- Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:

- Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease defined as:

- Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation
of CLL are eligible if they had >= one prior treatment, including prior BTK inhibition

- Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano
Response Criteria for Malignant Lymphoma.

- Measurable disease defined as measurable by CT portion of a PET/CT: To be considered measurable, the must be at least one lesion that has a single diameter of (>1.5 cm Note: Lesions that have been previously irradiated will
be considered measurable only if progression has been documented following completion of radiation therapy

- Biopsy proven SLL or flow cytometry proven CLL; relapsed disease defined as:

- >= two prior lines of therapy, and/or >= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance
mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.

- Demonstration of progressive or stable disease by PET/CT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria

- Measurable disease by CT portion of a PET/CT where at least one lesion has a single diameter of >1.5 cm or peripheral blood absolute blood lymphocyte count (ALC) of > 5000. Note: Lesions that have been previously irradiated
will be considered measurable only if progression has been documented following completion of radiation therapy

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

- Hemoglobin >= 8.0 g/dL (=< 14 days prior to registration)

- Absolute neutrophil count (ANC) >= 500/mm^3 (=< 14 days prior to registration)

- Platelet count >= 30,000/mm^3 (=< 14 days prior to registration)

- Total bilirubin =< 2.0 mg/dL (with the exception of subjects with Gilbert's syndrome.  Subjects with Gilbert's syndrome may be included if their total bilirubin is =< 3.0 x
upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULN) (=< 14 days prior to registration)

- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (=< 14 days prior to registration)

- Prothrombin time (PT) / international normalized ratio (INR) and/or activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding, and no recent deep venous thrombosis/pulmonary embolism (DVT/PE) within the last 6 months of enrollment)
(=< 14 days prior to registration)

- Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (=< 14 days prior to registration)

- Cardiac ejection fraction >= 50% and no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition scan
(MUGA) scan

- Baseline oxygen saturation >= 92% on room air

- Negative serum pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only

- Women patients of child bearing potential, including women with tubal ligations, must commit to using use 2 highly effective forms of birth control (defined as the use of
an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for 12 months following
IC19/1563 therapy

- Provide written informed consent

- Willingness to provide mandatory blood specimens for correlative research

- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)


Exclusion Criteria:


- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:

- Pregnant persons

- Nursing persons

- Women of childbearing potential who are unwilling to employ highly effective contraception

- Sexually active males who are not willing to use contraception during the study and for >= 12 months after IC19/1563 therapy

- Patients who are able to obtain market approved CD19 CAR T-cell therapies

- Live vaccine =< 6 weeks prior to start of registration

- Autologous stem cell transplant =< 6 weeks of registration

- History of allogenic stem cell transplant if was performed less than 100 days prior to registration, if patients have active graft-versus host disease (GVHD) or are if patients are on chronic immunosuppression. Patients with allogeneic transplantation more than 100 days prior to registration, with no active GVHD and who are not on
immunosuppression are eligible

- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS)
involvement

- Any form of primary immunodeficiency such as severe combined immunodeficiency disease

- Current need of systemic corticosteroid therapy, in doses over 20 mg /day of prednisone or equivalent forms of steroids

- History of severe immediate hypersensitivity reaction to CART19, stem cell infusion dimethyl sulfoxide (DMSO) or any of the CAR-T cryopreservation ingredients

- History of malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), unless disease free for >= 2 years

- Clinically significant active infection (e.g. simple urinary tract infection [UTI], bacterial pharyngitis allowed) or currently receiving IV antibiotics or have received
IV antibiotics =< 7 days prior to registration. Note: prophylactic antibiotics, antivirals and antifungals are permitted

- Known history of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection
must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines.
Prophylactic antiviral therapy should be considered per institutional guidelines

- History of any of the following cardiovascular conditions =< 6 months:

- Class III or IV heart failure as defined by the New York Heart Association (NYHA)

- Cardiac angioplasty or stenting

- Myocardial infarction

- Unstable angina

- Or other clinically significant cardiac disease

- Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that, in the judgment of the investigator, would make the subject inappropriate for entry into the study 

- Concurrent cancer therapy. The following are exceptions:

- Treatment with therapies may continue at time of registration; however, the washout period must be met prior to leukapheresis

- Treatment with any other investigational agent may continue at time of registration provided last date of treatment is =< 14 days prior to leukapheresis.

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

Eligibility last updated 10/19/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery
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Mayo Clinic — Rochester, MN

Social Outcomes in Patients Under 40 Years Old After Maxillofacial Reconstructive Surgery with Osseous Free Flaps for Benign Lesions of the Jaws

Social Outcomes in Patients Under 40 Years Old After Maxillofacial Reconstructive Surgery with Osseous Free Flaps for Benign Lesions of the Jaws

Kevin Arce Castro
All
21 years to 40 years old
This study is NOT accepting healthy volunteers
0000-120902-H01-RST
18-004746
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Inclusion Criteria:

  • Male and female patients between the age of 21 to 40 years.
  • Benign tumor or process of the jaw treated with segmental jaw resection and osseous free flap reconstruction (fibula, iliac crest or scapula).
  • Mental capacity and willingness to provide approved written informed consent.


Exclusion Criteria:
 

  • Age less than 21 years old and greater than 40 years old.
  • Reconstruction with non-vascularized bone grafting.
  • Treatment of the primary tumor with enucleation and curettage rather than respective surgery (i.e. without the need for free flap reconstructive surgery).
  • Index surgery performed outside of Mayo Clinic, Rochester.
Jaw tumors and cysts
Benign neoplasm of jaw, Free flap, Jaw surgery
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Mayo Clinic — Rochester, MN

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) (MAHALE)

Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis

Timothy Aksamit
All
18 years to 130 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306235-P01-RST
21-010918
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Inclusion Criteria:


- Male or female, at least 18 years of age inclusive at the time of signing the ICF

- Must have NCFB diagnosed by a physician and confirmed by CT (measured at screening; if
a new CT is not possible, a CT performed within 12 months of the screening visit is
acceptable).

- Documented history of 2 or more bronchiectasis exacerbations within a year of the
screening visit.

- If receiving prophylactic systemic or inhaled antibiotics to prevent bronchiectasis
exacerbations, the dose/regimen must be stable for at least 3 months prior to the
screening visit and remain stable throughout the DB period of the study. If
prophylactic macrolides have been recently discontinued, patients must have been off
treatment for at least 3 months prior to randomisation. In all other cases of
prophylactic antibiotic use, ≥ 4 weeks wash out period should be in place after the
last dose of antibiotic and prior to randomisation

- Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The
dose and regimen of these therapies and any drugs used to aid expectoration should be
stable for at least 3 months prior to the screening visit and remain stable throughout
the DB period of the study.

- If receiving inhaled corticosteroid or bronchodilator therapy, the dose and regimen
should be stable with no alteration to dose or formulation for at least 3 months prior
to the screening visit and this should remain stable throughout the DB period of the
study.

- Women of childbearing potential (WOCBP) must have a negative serum and urine pregnancy
test prior to randomization and agree to use a highly effective method of birth
control from enrollment, throughout the study duration, and for 12 weeks after the
last dose of IP.


Exclusion Criteria:


- Pulmonary disease other than bronchiectasis. Patients with a history of NTM disease
may be enrolled if they have completed treatment prior to the Screening visit, if at
least 3 months have elapsed since the last day of antibiotic treatment for NTM at the
Screening visit, and if they have had a negative sputum culture prior to the screening
visit.

- Another diagnosed or suspected pulmonary or systemic disease associated with elevated
peripheral eosinophil counts

- Respiratory infection or bronchiectasis exacerbation during the screening period.

- Any other clinical condition that is not stable in the opinion of the Investigator and
could:

1. Affect the safety of the patient during the study.

2. Influence the findings of the study or their interpretation.

3. Impede the patient's ability to complete the entire duration of the study.

- Radiological findings suggestive of a respiratory disease other than bronchiectasis,
suggestive of acute infection, or of solitary pulmonary nodules without appropriate
follow up and demonstration of stability as per standard of care. Pulmonary nodules >
6 mm in size should have at least 2 years of follow up with no change on CT imaging.

- Current active liver disease

- Current malignancy, or history of malignancy, except for:

1. Patients who have had basal cell carcinoma, localised squamous cell carcinoma of
the skin, or in situ carcinoma of the cervix are eligible provided the patient is
in remission and curative therapy was completed at least 12 months prior to Visit
1

2. Patients who have had other malignancies are eligible provided that the
participant is in remission and curative therapy was completed at least 5 years
prior to Visit 1.

- History of known immunodeficiency disorder including a positive test for human
immunodeficiency virus, HIV-1 or HIV-2.

- History of alcohol or drug abuse within the past year

- Current smokers with a tobacco history of ≥ 10 pack-years or ex-smoker with a tobacco
history of ≥ 10 pack-years.

- Patients receiving long-term oxygen treatment

- Patients participating in, or scheduled for, an intensive (active) pulmonary
rehabilitation programme. Patients who are in the maintenance phase of a
rehabilitation programme are eligible.

- Use of non-invasive positive-pressure ventilation for conditions other than
obstructive sleep apnoea

- Use of immunosuppressive medication within 3 months of the screening visit or expected
need for chronic use (≥ 4 weeks) during study

- Receipt of any marketed or investigational biologic products (monoclonal or polyclonal
antibody) within one year of the screening visit

- Receipt of any investigational non-biologic product within 30 days or 5 half-lives
prior to randomisation

- Receipt of immunoglobulin and blood products within 30 days of the date of the
screening visit

- Receipt of live attenuated vaccines within 30 days of the date of randomisation

- Concurrent enrolment in another clinical drug interventional trial

- History of anaphylaxis to any biologic therapy or vaccine

- Known history of allergy or reaction to any component of the IP formulation.

- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site)

- Judgement by the Investigator that the patient should not participate in the study if
the patient is unlikely to comply with study procedures, restrictions, and
requirements

- Previous randomisation in the present study

- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

Biologic/Vaccine, Other
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Bladder Bank (Bladder Bank)

Bladder Bank

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

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


Exclusion Criteria:
  

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

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

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Mayo Clinic — Rochester, MN

A Review of Midgut Malrotation in the Adult Population: Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure

Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure: A Review of Midgut Malrotation

William Perry
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308114-H01-RST
22-004723
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Inclusion Criteria:

  • Patients who underwent Ladd’s procedure. 


Exclusion Criteria:
  

  • < 18 years of age.

 

Band of Ladd, Malrotation of intestine with midgut volvulus
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A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People with Severe Von Willebrand Disease (VWD) (ATHN 9)

ATHN 9: Severe Von Willebrand Disease Natural History Study

Rajiv Pruthi
All
Not specified
This study is NOT accepting healthy volunteers
2021-306671-P01-RST
21-013017
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Inclusion Criteria:

  • Males and females.
  • Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPIbM or VWF:Ag ≤ 30% of pooled normal control plasma on more than one occasion.
  • Participants with clinically severe VWD as defined by VWF:RCo or VWF:Ag ≤ 40% of normal with severe bleeding phenotype defined as requiring use of recurrent factor concentrates.
  • Co-enrollment in the ATHN dataset.

Exclusion Criteria

  • Diagnosis of platelet-type VWD;
  • Diagnosis of acquired VWD (clinical diagnosis made by the hemophilia health care provider, typically based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention (TACSI)

All
21 Years and over
N/A
This study is also accepting healthy volunteers
NCT05465109
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Inclusion Criteria:

• the care recipient has a physician diagnosis of TBI and AD/ADRD (i.e., those with a diagnosis of both TBI and progressive cognitive decline)
• the caregiver self-identifies as someone who provides the most help/is most responsible for the person with TBI-AD/ADRD because of their cognitive impairments (or shares the role equally with another caregiver)
• the caregiver indicates a willingness to participate in the TACSI evaluation
• the caregiver is English speaking
• the caregiver is 21 years of age or older
• the caregiver is not currently participating in any other type of service that provides one-to-one psychosocial consultation or caregiver coaching (peer mentorship/support group participation/general counseling not specific to caregiving is not a deterrent to enrollment) at the discretion of the UMN research team
• the caregiver resides in the US.
Exclusion Criteria:

• caregivers who have a new or worsening mental health condition and are not receiving ongoing treatment. When applicable, if caregivers have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics or anti-psychotics, for the prior three months they will be excluded.
Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)
Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout
Caregiver, Traumatic brain injury, Alzheimer's, Dementia
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University of Minnesota — Minneapolis, Minnesota Joseph Gaugler, PhD - (gaug0015@umn.edu)

Intracardiac Flow Assessment in Cardiac Amyloidosis

Intracardiac Flow Assessment in Cardiac Amyloidosis

Ian Chang
All
40 years and over
This study is NOT accepting healthy volunteers
2022-307150-H01-RST
22-001098
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Inclusion Criteria:


- Subject is clinically stable without cardio-vascular-related hospitalizations within 6 weeks prior to enrollment as assessed by the investigators.

- Subject is able to provide written informed consent and is willing and able to complete study procedures.

- Currently in sinus rhythm by clinical assessment or documented electrocardiographic studies.

- Subject and disease characteristics noted by medical record review:

- Healthy control volunteers must also meet the following criteria: Karnofsky performance scale > 80%; ECOG status 0 or 1.

- ATTR cardiac amyloidosis based on meeting all the following criteria: Diagnosis of amyloidosis within two years prior to study screening; Documentation of absence of AL, heavy chain disease, multiple myeloma or malignant
lymphoproliferative disorders; Transthyretin amyloid deposits in cardiac tissue OR technetium (99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake OR Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic evidence of cardiac involvement or an end-diastolic mean wall thickness > 12mm OR
Transthyretin amyloid deposits in non-cardiac tissue with CMR diagnostic of amyloidosis

- AL with cardiac involvement based on meeting all the following criteria:  Diagnosis of amyloidosis within two years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; Documented clinical signs or symptoms consistent with heart failure; Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence of other causes OR Elevated NT-proBNP (> 332 ng/L) in the absence of renal failure or atrial fibrillation OR CMR diagnostic of amyloidosis;

- AL without cardiac involvement based on meeting all the following criteria:  Diagnosis of amyloidosis within two years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; No documented clinical signs and symptoms consistent with heart failure from AL; Absence of cardiac involvement as defined by: Echocardiography with an end-diastolic mean wall thickness < 13 mm if the subject does not have other causes for increased wall thickness AND NT-proBNP < 333 ng/L if the subject does not have renal failure or atrial fibrillation AND
No CMR diagnostic of amyloidosis if CMR is available prior to screening.


Exclusion Criteria:


- Unable to consent or unable to complete all study procedures.

- Unable to ambulate for 6 minutes (confirmed at study coordinator visit).

- Unable to maintain in supine position for 30 minutes.

- Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit).

- Contraindications for safe CMR scanning (e.g., claustrophobia, cochlear implant, implanted neural stimulator).

- Presence of implantable cardiac pacemaker, defibrillator or recorder.

- History of intracardiac prosthesis, congenital heart disease, intracardiac shunt, prior intrathoracic surgery, or procedures to the thoracic aorta or pulmonary arteries.

- Significant artifact from prior MRI studies.

- Pregnant or breast-feeding women.

- Weight equal to or greater than 155 kg.

- Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70 cm.

- Documented non-sinus rhythm within 6 months prior to screening.

- For healthy controls, the following exclusion criteria apply, confirmed per chart review and/or patient report:

- History of cardiomyopathy or structural heart disease;

- History of valvular disease of greater than mild severity;

- History of coronary artery disease or coronary heart disease;

- History of cardiac or thoracic surgery.

- History of atrial tachyarrhythmia, ventricular tachyarrhythmia, or symptomatic bradyarrhythmia;

- Left ventricular hypertrophy or abnormally increased myocardial thickness by prior echocardiography, cardiac computed tomography, or CMR;

- Acute kidney injury, OR chronic renal disease with glomerular filtration rate < 60 mL/min/1.73m^2 as per medical record review.

- Uncontrolled hypertension of systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg as per medical record review;

- Taking two or more anti-hypertensive medications;

- Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c greater than 7, as per medical record review;

- Taking two or more diabetic medications;

- History of stroke or transient ischemic attack;

- Current cigarette smoker;

- History of peripheral artery disease of aortopathy;

- History of plasma cell dyscrasia or chronic hematologic diagnosis;

- BMI > 35 kg/m^2.

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

Eligibility last updated 12/28/23. Questions regarding updates should be directed to the study team contact.

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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Female
21 Years to 45 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05467150
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Inclusion Criteria:

• Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
• BMI 18.5-45 kg/m2 at first prenatal visit
• Age 21-45 at time of delivery
• Report social support for and intention to exclusively breastfeed for at least 3 months
• Singleton pregnancy
Exclusion Criteria:

• Alcohol consumption >1 drink per week during pregnancy/lactation
• Tobacco consumption during pregnancy/lactation
• Inability to speak/understand English
• Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• History of type I Diabetes
• Birthing parent currently taking over the counter probiotic preparation
Dietary Supplement: Probiotic Supplement
Infant of Diabetic Mother
infant of diabetic mother, probiotic, gut microbiome, neurodevelopment
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University of Minnesota — Minneapolis, Minnesota Marie Hickey Swanson, MD - (hick0245@umn.edu)

A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab (HZNP-TEP-402)

TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

Marius Stan
All
18 years to 80 years old
Phase 4
This study is NOT accepting healthy volunteers
2021-305679-P01-RST
21-008801
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Inclusion Criteria:


1. Written informed consent.

2. Male or female between the ages of 18 and 80 years, inclusive, at Screening.

3. Initial diagnosis of TED within 7 years prior to Screening.

4. Proptosis ≥ 3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis > 3 mm above normal for race and gender.

5. Participants must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% above or below the normal limits) at Screening. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the duration of the trial.

6. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.

7. Diabetic participants must have HbA1c ≤8.0% at Screening.

8. Participants with a history of IBD (ulcerative colitis or Crohn's disease) must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial. Concomitant stable therapies for IBD without modifications in the 3 months prior to Screening are allowed.

9. Women of childbearing potential (including those with an onset of menopause < 2 years prior to Screening, non-therapy-induced amenorrhea for < 12 months prior to Screening or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout the participant's participation in the Follow-up Period); participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of teprotumumab. Highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include implants, injectables, combination oral contraceptives, some intrauterine devices, tubal ligation, sexual abstinence or vasectomized partner.

10. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.


Exclusion Criteria:


1. Decreased best-corrected visual acuity due to optic neuropathy, as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement within the last 6 months.

2. Corneal decompensation unresponsive to medical management.

3. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.

4. Prior orbital irradiation, orbital decompression or strabismus surgery.

5. Planned eyelid surgery during the course of the trial.

6. Alanine aminotransferase or aspartate aminotransferase > 3 × the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73m^2 at Screening.

7. Any systemic use of any steroid (intravenous or oral) or steroid eye drops for the treatment of TED or other conditions within 3 weeks prior to Screening. Such steroids cannot be initiated during the trial. Exceptions include local administration (excluding steroid eye drops); e.g., topical (for skin only), intraarticular, and inhaled steroids, as well as steroids used to treat infusion reactions.

8. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.

9. Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial.

10. Treatment with any mAb within 3 months prior to Screening.

11. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results.

12. Use of an investigational agent for any condition within 60 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the
trial.

13. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).

14. Pregnant or lactating women.

15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant.

16. Known hypersensitivity to any of the components of teprotumumab or prior hypersensitivity reactions to mAbs.

17. Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections.

18. Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.

19. After 150 participants with a CAS < 3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS < 3 at Baseline.

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

Eligibility last updated 10/4/23. Questions regarding updates should be directed to the study team contact.

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A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) (HUDSON)

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

Puanani Hopson
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304415-P01-RST
21-004056
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Inclusion Criteria:

  • Participant must be at least 12 years of age at the time of signing the ICF or informed assent form.
  • Clinician confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
  • Participants who have documented previous diagnosis of eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone. This will be confirmed by biopsy for the purpose of this study, defined as a gastric count of ≥ 30 eosinophils/hpf in at least 5 hpfs and and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia (e.g., parasitic or other infection or malignancy). Participants can have duodenal only disease and be enrolled in the duodenal only subject population. 
  • At Visit 1 (screening), participants who in the investigator’s judgement have a history of symptoms of abdominal pain, nausea, bloating, early satiety, and/or loss of appetite to an extent that they would meet criteria 5 at Visit 2.
  • At Visit 2 (randomisation), participants who are symptomatic, defined as having a mean SAGED score > 12 (on a 0 to 50 point scale) over the last 14 days of the run-in period.
  • Must be adherent to daily PRO assessments:
    • Must complete 70% SAGED, DSQ, and Bristol Stool Form Scale assessments between Visit 1 and Visit 2; AND
    • Must have completed at least 8 of 14 SAGED assessments in the 14 days prior to randomization.
  • If on background medications for EG/EGE during the study, background medications have been stable for at least 4 weeks prior to the run-in period.
    • Patient must agree not to change type of background medication or dosage during the study unless medically indicated or allowed by protocol during Part C OLE after Week 52 as clinically indicated. If a medication for EG/EGE (including swallowed steroids, systemic steroids and PPI) is discontinued prior to screening, there should be a washout period of at least 8 weeks prior to screening. 
  • Negative serum pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (enrollment).
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Female participants:
    • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply:
    • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and have follicle stimulating hormone levels in the postmenopausal range.  Until FSH is documented to be within menopausal range, she should be treated as a WOCBP:
      • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
  • Female participants that are WOCBP must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. WOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrollment throughout the study and until at least 12 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of child bearing potential must have a negative serum pregnancy test result at Visit 1.
  • Highly effective birth control methods include:
    • Combined (estrogen and progestogen ) 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;
    • Intrauterine hormone-releasing system;
    • Bilateral tubal occlusion;
    • Sexual abstinence, ie refraining from heterosexual intercourse (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient);
    • Vasectomized sexual partner provided that partner is the sole sexual partner of the WOCBP study patient and that the vasectomized partner has received medical assessment of the surgical success.
  • Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.


Exclusion Criteria:

  • Any disorder, including, but not limited to, cardiovascular, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
    • Affect the safety of the patient throughout the study;
    • Influence the findings of the studies or their interpretations;
    • Impede the patient’s ability to complete the entire duration of study.
  • Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
  • Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
  • Current malignancy, or history of malignancy, except for patients who have had basal cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained. Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Current active liver disease:
    • Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis;
    • Alanine aminotransferase or aspartate aminotransferase level > 3 times the upper limit of normal, confirmed by repeated testing during the run-in period. Transient increase of aspartate aminotransferase/alanine aminotransferase level that resolves by the time of randomization is acceptable if in the Investigator's opinion the patient does not have an active liver disease and meets other eligibility criteria.
  • Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent or assent (if applicable) is obtained that has not been treated with or has failed to respond to standard of care therapy.
  • Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during run-in period, which in the opinion of the Investigator, may put the patient at risk, because of his/her participation in the study, or may influence the results of the study, or the patients' ability to complete entire duration of the study.
  • Known immunodeficiency disorder including testing positive for HIV.
  • Concomitant use of immunosuppressive medication (including but not limited to:
    • methotrexate, cyclosporine, and azathioprine.
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent or assent is obtained.
  • Receipt of live attenuated vaccines 30 days prior to date of informed consent or assent.
  • Receipt of inactive vaccines within 7 days of informed consent or assent.
  • Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent or assent (if applicable), is obtained, whichever is longer, and during the study period.
  • Previous participation in a benralizumab clinical study.
  • Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives prior to randomization, whichever is longer.
  • Participants with a known hypersensitivity to benralizumab or any of the excipients of the product.
  • Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group from 6 weeks prior to start of the run-in period and unable or unwilling to remain on a stable diet until the completion of Week 52.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • For women: currently pregnant confirmed with positive pregnancy test or breast-feeding.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

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

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

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

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

Exclusion Criteria
•Registration:

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

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

All
21 Years to 75 Years old
This study is also accepting healthy volunteers
NCT05471960
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Inclusion Criteria for the iRBD Group:
• Diagnosis of polysomnogram-confirmed isolated iRBD.
• Able to ambulate independently without the use of an assistive device (e.g., cane) for 50 meters.
• Age: 21-75 years. Inclusion Criteria For Control Subject Group:
• Age: 21-75 years.
• Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters. Exclusion criteria for iRBD group:
• Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent.
• History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment.
• Other significant neurological disorders that may affect participation or performance in the study.
• Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.
• Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).
• Untreated sleep-disordered breathing
• History of musculoskeletal disorders that significantly affect movement of lower or upper limbs as determined at the time of enrollment.
• Pregnant women
• Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment
• If participant is taking one of the following medications that affects neuroplasticity testing, they will be excluded from the TMS experiment: haloperidol (dopamine antagonist), prazosin (norepinephrine antagonist), biperiden (acetylcholine antagonist), dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs (benzodiazepines), lithium, lovastatin, and cannabis. Exclusion Criteria for Control subject Group:
• Same as exclusion criteria as the iRBD group
• History of dream enactment from either patient report or from a bed partner witness that may suggest iRBD.
• History of untreated sleep-disordered breathing.
• Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).
• Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning
Other: No intervention
Parkinson
Parkinson
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University of Minnesota — Minneapolis, Minnesota Josh De Kam - (jadekam@umn.edu)

Analysis of Biomarkers in Type 1 Diabetes Mellitus

Analysis of Biomarkers in Type 1 Diabetes Mellitus

Yogish Kudva
All
18 years and over
This study is NOT accepting healthy volunteers
0000-118940-H01-RST
16-007107
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Inclusion Criteria:

  • T1D
  • eGFR ≥ 60 ml/mt
  • Capable of providing informed consent


Exclusion Criteria:
 

  • eGFR ≤ 60 ml/mt
  • Pregnancy
Acute kidney failure, Diabetes, Type 1 diabetes
Endocrine system, Type 1 diabetes mellitus, Urinary system
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Mayo Clinic — Rochester, MN

A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) (AVTX-803)

A Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)

Eva Morava-Kozicz
All
6 months to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306143-P01-RST
21-010539
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Inclusion Criteria:


- Subject must be between 6 months and 75 years old

- Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

- Subject has a documented history of Lewis antigen deficiency

- Subject has a history of recurrent infections, opportunistic infections or infections
that did not respond well to standard of care treatment

- Subject or parent (for subjects under legal age for consent) has provided written
informed consent for this study. Additionally, written informed assent has been
provided, as appropriate, for minors of older age, per local institutional review
board (IRB)/ethics committee (EC) policy and requirements

- Subject is willing and able to comply with the protocol

- Women of childbearing potential (WOCBP) meeting the criteria below:

1. Non-lactating and has a negative pregnancy test at screening -AND-

2. Uses an acceptable double-barrier method of contraception as determined by the
investigator or sub-investigator for the duration of the study and 30 days
following the last dose of study drug.

- Male subjects must agree to use an acceptable double-barrier method of contraception
with their partner as determined by the investigator or sub-investigator for the
duration of the study and 30 days following the last dose of study drug.


Exclusion Criteria:


- Subject has severe anemia defined as hemoglobin <8.0 g/dL (<4.9 mmol/L)

- Subject has impaired renal function as defined by an eGFR <90 mL/min

- Subject has a total absence of fucosylation on red blood cells and the presence of
anti-H antigen

- Subject has known or suspected intolerance or hypersensitivity to fucose or any
ingredients of the investigational product

- In the investigator's opinion, subject has a history of failure to respond to fucose
at adequate dosing

- In the investigator's opinion, subject is not able or not willing to comply with the
study requirements.

- Subject is pregnant

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

Drug
Congenital disorder
Leukocyte adhesion deficiency - type 2, fucose
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Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis (APPLe)

Advancing Prevention of Pulmonary Fibrosis

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

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


Exclusion Criteria:

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

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

 

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A Double-Blind, Randomized, Placebo Controlled, Two Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administrated Orally to Subjects with Chronic Cough (ADX-629-CC-001)

Evaluating the Safety, Tolerability and Effectiveness of ADX-629 t to Treat Chronic Cough

Vivek Iyer
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306794-P01-RST
22-000292
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Inclusion Criteria:


- Adults ≥18 to ≤80 years of age

- History of refractory or unexplained chronic cough

- Historical Chest radiograph or CT scan that does not demonstrate any abnormality
considered to be significantly contributing to chronic cough

- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method
of acceptable contraceptive for the trial duration, if applicable

- Agree to discontinue antitussive medications for the trial duration


Exclusion Criteria:


- Current smoker (including cannabis products) or previous smoker having recently given
up smoking or has a history of smoking of >20 pack-years

- History of significant cardiovascular disease or any clinically significant
abnormalities in rhythm or conduction

- History or presence of significant hepatic disease or any other condition known to
interfere with absorption, distribution, metabolism, or excretion of drugs.

- History of any malignancy within 5 years of screening except for basal cell or
squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been
treated with no evidence of recurrence.

- Recent history of drug or alcohol abuse or a positive urine drug test at screening

- Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1
and HIV-2

- Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI
within 3 months of Screening.

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

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

Drug, Other
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Preliminary Evaluation of At-Home Self-Collection for Pre-Transplant Patients

At-Home Self-Collection for Pre-Transplant Patients

Manish Gandhi
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308101-H01-RST
22-004659
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Inclusion Criteria:

  • Adult (≥ 18 years) pre-transplant kidney patient.


Exclusion Criteria:

  • Individuals < 18 years.
  • Not pre-transplant kidney patient.

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

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Molecular Breast Imaging (MBI) Patient Survey

Patient Survey of Molecular Breast Imaging

Carrie Hruska
Female
21 years and over
This study is NOT accepting healthy volunteers
2022-308388-H01-RST
22-006013
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Inclusion Criteria:

  • Female.
  • MBI exam performed at Mayo Clinic in Rochester, MN.
  • Email address provided in the medical record.


Exclusion Criteria:

  • Protected research populations (pregnant women, prisoners, children, and adults lacking capacity to consent) will not be included in the study.

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

 

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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy (Vedo UC)

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis

Michael Stephens
All
2 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-303961-P01-RST
21-002340
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Inclusion Criteria:


1. Has moderately to severely active UC, unresponsive or intolerant to their current
standard of care (SOC).

2. Weighs ≥10 kg at the time of screening and enrollment into the study.

3. Has moderately to severely active UC diagnosed at least 1 month before screening,
defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool
frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of
≥2 (with the presence of mucosal friability excluding an endoscopic subscore 1 and
mandating a score of at least 2).

4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the
following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP],
methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-?)
antagonist therapy (eg, infliximab, adalimumab). This includes participants who are
dependent on corticosteroids to control symptoms and who are experiencing worsening of
disease in the moderate-to-severe range when attempting to wean off corticosteroids.

5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis),
at a minimum.

6. Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12
years' duration must have documented evidence of a negative surveillance colonoscopy
within 12 months before screening.

7. Participants with vaccinations that are up-to-date based on the countrywide, accepted
schedule of childhood vaccines.


Exclusion Criteria:


1. Has previous exposure to approved or investigational anti-integrins including, but not
limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal
addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.

2. Has received an investigational biologic within 60 days or 5 half-lives before
screening (whichever is longer); or an approved biologic or biosimilar agent within 2
weeks before the first dose of study drug or at any time during the screening period.

3. Has active cerebral/meningeal disease, signs/symptoms or history of progressive
multifocal leukoencephalopathy (PML) or any other major neurological disorders
including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.

4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus
disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.

5. Has received any live vaccinations within 30 days prior to first dose of study drug.

6. Participants who currently require surgical intervention or are anticipated to require
surgical intervention for UC during this study.

7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy,
ileo-anal pouch, or known fixed stenosis of the intestine.

8. Participants with a current diagnosis of indeterminate colitis.

9. Participants with clinical features suggesting monogenic very early onset inflammatory
bowel disease.

10. Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB
test performed within 30 days of screening or during the screening period that is
positive, defined as:

- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR

- A TB skin test reaction ≥5 mm. NOTE: If participants have received Bacillus
Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed
instead of the TB skin test.

11. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus infection.

- HBV immune participants (ie, being hepatitis B surface antigen negative and
hepatitis B antibody positive) may be included, however.

12. The participant has evidence of dysplasia or history of malignancy other than a
successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or
localized carcinoma in situ of the cervix.

13. Has positive stool studies for ova and/or parasites or stool culture at screening
visit.

14. Has positive Clostridium difficile stool test at screening visit.

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

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Cardiolipin Profiling for Barth Syndrome Screening and Characterization (CPfBSSaC)

Cardiolipin Profiling for Barth Syndrome Screening and Characterization

Devin Oglesbee
All
Not specified
This study is NOT accepting healthy volunteers
2021-305433-H01-RST
21-007892
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Inclusion Criteria:

  • Specimens (dried blood spots, whole blood, or retrospectively available cultured cells) from Barth subjects and controls identified by the Barth Syndrome Foundation and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.
  • Residual specimens from the Mayo Clinic Biochemical Genetics Laboratory:
    • Up to 1,000 control subjects from pediatric and adult populations through age 99 on date of relevant specimen collection.
  • Data collected as part of the Barth Syndrome Foundation Registry and Biorepository and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.


Exclusion Criteria:

  • None.

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

 

Genetic disorder
3-Methylglutaconic aciduria type 2
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Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (FibroGen095)

Zephyrus II: Effectiveness and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Teng Moua
All
40 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306608-P01-RST
21-012801
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Key

Inclusion Criteria:


1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.

2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.

3. FVCpp value >45% and <95% at Screening and Day 1.

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and
≤90%.

5. Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib)
but discontinued at least 1 week prior to screening, unless neither treatment is
available in the host country.

Key
Exclusion Criteria:


1. Previous exposure to pamrevlumab.

2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.

3. Female participants who are pregnant or nursing.

4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
study.

5. Interstitial lung disease other than IPF.

6. Sustained improvement in the severity of IPF.

7. Other types of respiratory diseases that, in the opinion of the Investigator, would
impact the primary protocol endpoint or otherwise preclude participation in the study,
including diseases of the airways, lung parenchyma, pleural space, mediastinum,
diaphragm, or chest wall.

8. Certain medical conditions, that, in the opinion of the Investigator, would impact the
primary protocol endpoint or otherwise preclude participation in the study (such as,
myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or
cancers).

9. Acute IPF exacerbation during Screening or Randomization including hospitalization due
to acute IPF exacerbation within 4 weeks prior to or during screening.

10. Recent use of any investigational drugs or unapproved therapies, or participation in
any clinical trial.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient.

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact

Biologic/Vaccine, Other
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GRASP-IBD (GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease) (GRASP-IBD)

GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease

John Davis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308107-H01-RST
22-004690
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Inclusion Criteria:

  • Adult patients, ages 18-70 years.
  • Patients with Irritable Bowel Disease (IBD).


Exclusion Criteria:

  • Patients < 18 and over 70 years of age.

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

 

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Hepatic Steatosis Quantification with Ultrasound

A Study Evaluating the Effectiveness of Ultrasound Imaging for Liver Steatosis Staging

Shigao Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306462-H01-RST
21-011918
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Patients with clinically indicated MRI-PDFF (Proton Density Fat Fraction) for liver imaging.

Exclusion Criteria

  • Individuals < 18 years old.
  • Vulnerable subjects such as:
    • Prisoners;
    • Adults lacking capacity to consent.
  • Patients with liver iron overload, which may confound PDFF measurements.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Bipolar Disorder Measures in Clinical Care - Patient Preferences on Measures

Bipolar Disorder Measures in Clinical Care

William Leasure
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307697-P01-RST
22-003286
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Inclusion Criteria:

  • 18 years or older with a clinician diagnosis of bipolar disorder (any bipolar disorder type including bipolar I disorder, bipolar II disorder, cyclothymic disorder, and unspecified bipolar and related disorder).
  • Ability to consent to participation in research. 
  • Patients (n=10) will be recruited from those currently receiving treatment in the included clinics in the Mayo Clinic (Collaborating Institution). 
  • Additionally, stakeholder partners at the Depression and Bipolar Support Alliance will publicize our research study and identify 10-15 individuals with bipolar disorder currently receiving treatment to participate.


Exclusion Criteria:

  • Among participants recruited from the Mayo Clinic, individuals who are not intending to return to care in that system.
  • No exclusion criteria apply to participants recruited from the Depression and Bipolar Support Alliance.
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Advanced Cardiac Imaging Processing with the MUSIC Software for Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Konstantinos Siontis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306923-H01-RST
21-010613
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Inclusion Criteria:
           

  • Male or female adults (≥ 18 years old).
  • Frequent premature ventricular complexes or documented episode(s) of sustained VT, or evidence of appropriate ICD therapy in patients already implanted with ICDs.
  • Structural heart disease, defined as impairment of left ventricular ejection fraction on echocardiography or MRI and/or presence of structural abnormality on imaging (myocardial late gadolinium enhancement on MRI, myocardial wall thinning, hypodensity or calcification on MDCT), and/or borderline, possible or definite diagnosis of arrhythmogenic right ventricular cardiomyopathy according to modified Task Force criteria.


Exclusion Criteria:
 

  • Contraindications to VT/PVC catheter ablation:
    • Current intra-cardiac thrombus;
    • Unstable angina and other acute or reversible cause;
    • Current or anticipated participation in any other clinical trial of a drug, device or biologic.
  • Unwillingness to undergo CT and/or MRI imaging.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls

A Study to Evaluate 4DCT Controls

Kristin Zhao
All
18 years to 60 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-301579-H01-RST
20-007668
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Inclusion Criterion:

  • Age ≥ 18 and ≤ 60 years.
  • Control subjects without any history of wrist injury or disease.

Exclusion Criteria (applied to both wrists for control subjects): 

  • Previously-diagnosed rheumatological conditions or connective tissue diseases.
  • Inability to be appropriately positioned in the scanner for the imaging.
  • Congenital malformations of the wrist or forearm.
  • Diagnosed wrist osteoarthritis.
  • Age under 18 or over 60.
Other, CT of wrist
Wrist pain
CT scan, Finding of wrist joint, Musculoskeletal system
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Image guidance navigation provides objective feedback that can be used to evaluate surgical trainees and consultants. (TruDi)

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

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

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


Exclusion Criteria:
   

  • Anyone not meeting inclusion criteria or anyone not wishing to participate.
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A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions (ROBOCOP)

Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Ryan Kern
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-306281-H01-RST
21-008716
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Inclusion Criteria:

  • Male and female patient’s age ≥ 18 at the time of informed consent.
  • Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

  • Pulmonary nodules of 8-50mm in largest dimension.


Exclusion Criteria:

  • Patients with known bleeding diathesis; Platelet count < 50,000.
  • Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
  • Inability or unwillingness to give informed consent.
  • Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
  • Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
  • Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
  • International Normalized Ratio (INR) < 1.5.
  • Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Eligibility last updated 10/20/21. Questions regarding updates should be directed to the study team contact.

Device
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Evaluation of Implantable Tibial Neuromodulation (TITAN 2) Pivotal Study (TITAN 2)

Study to Evaluate Implantable Tibial Neuromodulation

Brian Linder
All
18 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-306307-P01-RST
21-011172
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Inclusion Criteria:

  • Subjects 18 years of age or older.
  • A 3-day voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 hours.
  • Have a diagnosis of UUI for at least 6 months.
  • No OAB pharmacotherapy for 2 weeks prior to completion of the baseline voiding diary and Overactive Bladder Quality of Life (OAB-q) questionnaire.
  • Failed, or are not a candidate for, conservative non-pharmacologic treatment (e.g., pelvic floor training, biofeedback, behavioral modification)
  • In the opinion of the Investigator, subject has failed and/or is intolerant to at least 1 overactive bladder medication or Investigator has determined that medication use is not appropriate based on the subject’s profile and medical history.
  • Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol.
  • Willing and able to provide signed and dated informed consent.


Exclusion Criteria:

  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • Severe uncontrolled diabetes.
  • History of urinary retention within the previous 6 months.
  • Current symptomatic urinary tract infection.
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component [see enrollment/baseline requirements for use of the Medical, Epidemiological, and Social Aspects of Aging urinary incontinence questionnaire (MESA) questionnaire].
  • Diagnosis of bladder pain syndrome, pelvic pain, or interstitial cystitis.
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • History of a prior implantable tibial neuromodulation system.
  • Knowledge of planned diathermy procedures.
  • Have had treatment of urinary symptoms with sacral neuromodulation in the past 6 months, botulinum toxin therapy in the past 9 months or percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) in the past 3 months.
  • Skin lesions or compromised skin integrity (e.g., skin atrophy, thinning, fragility, etc.) which may affect incision healing at the implant site.  Current or a recent history (within the past 6 months) of a medical condition such as venous insufficiency and/or venous stasis ulcers, clinically significant malnutrition, immunocompromised state, or other relevant chronic disease which may indicate a higher risk for delayed or poor wound healing.
  • Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device (including any metal implant that is within 20 cm of the intended neurostimulator location).
  • Previous pelvic floor surgery in the last 6 months.
  • Women who are pregnant or planning to become pregnant during the course of the study.
  • Any subject who is considered to be part of a vulnerable patient population.**
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.***
Device, Percutaneous electrical nerve stimulation of tibial nerve for urinary incontinence
Urinary incontinence
Urinary system
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