Maternal-fetal Immune Responses to Fetal Surgery
A Study to Evaluate Maternal-fetal Immune Responses to Fetal Surgery
- Maternal age ≥ 18 years old.
- Pregnant with a congenital anomaly diagnosis.
- Undergoing endoscopic in utero fetal intervention.
- Singleton pregnancy
- Delivery planned at Mayo Clinic.
- Maternal age ≥ 18 years old.
- Pregnant with normal ultrasound findings.
- Singleton pregnancy
- Delivery planned at Mayo Clinic.
- Delivery planned elsewhere.
- Abnormal fetal karyotype.
- Multiples (i.e. twins/triplets, etc)
- Undergoing open in utero fetal intervention
Pathogenesis and Mechanisms of Mitral Annular Calcification
A Study to Assess the Biological Progression and Mechanisms of Mitral Annular Calcification
- Patients with diagnosis of mitral annular calcification (MAC) (case group) and patients coming to the Valve Clinic without MAC diagnosis (control group).
- Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC (case group) or without diagnosis of MAC (control group).
- Subjects unwilling to participate or to provide consent.
Isolation, Activation and Expansion of Mutation Reactive T-cells
A Study to Analyze Isolation, Activation and Expansion of Mutation Reactive T-cells
- Adults, ≥ 18 years old.
- Adults with lung disease undergoing lung resection surgery.
- < 18 years old.
CELLTOP Part II: A Phase II Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury
A Study to Evaluate Autologous Adipose Derived Mesenchymal Stem Cells to Treat Spinal Cord Injury Patients
- Male or female aged 18 years and older.
- Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
- Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- AIS grade A or B of SCI at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional improvement
- SCI must be traumatic, blunt/non-penetrating in nature and not degenerative.
- Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments.
- Full understanding of the requirements of home exercise program prescribed by physical and occupational therapists.
- Once the nature of the study is fully explained and prior to any study-related procedure is initiated the subject is willing to provide written, informed consent and complete HIPAA documentation.
- Pregnant or nursing, or planning on becoming pregnant during the study period.
- AIS grade of SCI other than A or B at the time of injury.
- Non-traumatic SCI.
- History of receiving mesenchymal stem cell, gene or exosome therapy for any indications.
- History of intra-spinal infection
- History of superficial infection in the index spinal level within 6 months of study.
- Evidence of current superficial infection affecting the index spinal level at the time of enrollment.
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
- Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline.
- Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater.
- Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes, osteoporosis).
- History of malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
- History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
- Known allergy to local anesthetics of other components of the study drug.
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
- History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry.
- Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment.
Validation of Dried Blood Spot Testing for HIV Screening and Syphilis Serology
A Study to Screen HIV and Syphilis Screening Using Dried Blood Spot Testing
- Patients who are > 18 years of age.
- Patients who are either known to be HIV seropositive or have a positive syphilis serology or who require HIV or syphilis serologic testing as part of their routine care.
- Unable due to cognitive or physical limitations to understand dried blood spot collection instructions or to safely perform finger-stick for DBS self-collection.
- Patients who are unable to give informed consent.
MC1973: A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk
Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk
- Males and females, age ≥ 18 years.
- Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either:
- Deemed a candidate for complete macroscopic resection of the primary sarcoma; OR
- Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy.
- No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
- Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3.
- Life expectancy greater than 6 months.
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Ability to provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues.
- Patients with nodal or distant metastases.
- Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
- Any of the following:
- Pregnant women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
Pilot Studies on Non-invasive Measures of Cardiac Hemodynamics during Submaximal Exercise
A Study to Measure Cardiovascular Blood Flow During Submaximal Exercise
- Healthy participants above the age 18 years old.
- Participants capable of performing submaximal exercise.
- Participants less than the age of 18 years and older than 65.
- Participants with compromised cardiovascular or pulmonary function.
- Unable to pedal an exercise ergometer.
ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA) (ARREST)
ARrest RESpiraTory Failure From PNEUMONIA
- Severe Pneumonia defined as hospitalization for acute (< 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L), OR known current immunosuppression preventing inflammatory response.
- Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.
- A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments).
- Contraindication or known allergy to inhaled corticosteroids or beta-agonists.
- Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation).
- Intubation (or impending intubation) prior to enrollment.
- This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment.
- Do Not Intubate order but does not include a "Do Not Resuscitate" order.
- Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome.
- Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization.
- Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours, or K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved.
- Younger than 18 years of age.
ROR1905: Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
A Study to Evaluate Human Papilloma Virus Circulating Tumor DNA in Cervical Cancer
- Age ≥ 18 years.
- Able to provide written consent.
- Patient has given permission to give tumor/blood sample for research testing.
- Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
- Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV.
- Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits.
- Consent to allow blood specimens to be shared with potential external collaborators.
- Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC):
- FIGO 2019 Stage IB2-IIIC or not a surgical candidate;
- Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy.
- Other active malignancy ≤ 2 years prior to registration.
- EXCEPTIONS: Non-melanotic skin cancer.
- NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer.
- Pregnancy or lactation.
- Inability on the part of the patient to understand the informed consent to be compliant with the protocol.
Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.
Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System With Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine (TLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
A subject must meet all of the following inclusion criteria to participate in this study:
- Has radiographic evidence (i.e., CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:
- History of radiating leg or buttock pain, paresthesia, numbness or weakness; or
- History of neurogenic claudication.
- *If a subject hasn’t had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained.
- Has a history of low back pain.
- Has radiographic evidence (i.e., CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine including at least one of the following:
- Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm; or
- Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability; or
- Recurrent disc herniation.
- *If a subject hasn’t had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained.
- Has preoperative Oswestry Disability Index score ≥ 35.
- Has preoperative back pain and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.
- Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
- Is at least 18 years of age and skeletally mature at the time of surgery.
- Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
- Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.
A subject will be excluded from participating in this study for any of the following reasons:
- Prior surgical procedure at the involved or adjacent spinal levels (e.g., bony decompression, fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
- Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis > 30 degrees.
- Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. If subject has a prevalent fragility fracture and a T-score hasn’t been assessed in the last 12 months, a DEXA will need to be obtained.19/
- Morbidly obese, as defined by a Body Mass Index (BMI) > 40.
- Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
- Overt or active bacterial infection, either local to surgical space or systemic.
- Has undergone administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.
- This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment;
- Use of steroidal inhalers, short-term NSAID use, and short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks;
- Use of NSAIDs and/or steroids for longer than two weeks post-operatively through the 24 Month Follow-Up Visit is prohibited.
- Co-morbidities, which in the investigator’s opinion, precludes the subject from being a surgical candidate.
- Autoimmune disease, which in the investigator’s opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves’ disease, Hashimoto’s thyroiditis).
- Any endocrine or metabolic disorder, which in the investigator’s opinion, is known to affect osteogenesis (e.g., Paget’s disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- Known exposure to any recombinant proteins used for bone formation (e.g., Infuse™ Bone Graft, OP1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
- Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
- History of any allergy resulting in anaphylaxis.
- Is a prisoner.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- Pregnant or nursing.
- Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
- A documented diagnosis of substance use disorder as defined by the DSM-5. (Nicotine use is allowed.)
- Pursuing worker’s compensation or active litigation for spinal fusion procedure.
- Any condition, which in the investigator’s opinion, would interfere with the subject’s ability to comply with study instructions, which might confound data interpretation.
Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.
Transform the Practice – Pilot Study: Radio Signal Characterization of Seizures
A Study to Evaluate Radio Signal Characterization of Seizures
- Consented adult (18+) male and female subjects who are admitted to the Mayo Clinic Hospital (Saint Marys Campus) Inpatient Epilepsy Monitoring Unit.
- Have a confirmed diagnosis of epilepsy (by a Mayo Clinic Neurologist).
- Subjects who are pregnant or may be pregnant.
- Pediatric patients (< 18 years of age).
- Subjects who are unable to provide consent.
- Those admitted primarily for classification of indeterminate (possibly non-seizure) events.
- Subjects who plan to have more than one additional person in the room with them during nocturnal hours (10 pm – 6 am) (excluding clinical providers).
- Subjects who have an implanted vagal nerve stimulator or other neurostimulation device.
- Patients with implantable drug delivery systems or implanted cardiac devices (including pacemakers and defibrillators).
The Use of Virtual Reality Modules to Reduce Pre-Operative Anxiety in a Cardiac Surgery Inpatient Population
Healium Virtual Reality Protocol
- Able to understand the goals of the study and provide informed consent.
- Any hospitalized patient scheduled for a first-time sternotomy or thoracotomy under the care of Mayo Clinic cardiovascular inpatient service or thoracic inpatient service admitted after 1 February 2020, who is not excluded due to criteria listed below.
- Between the ages of 21 and 80 years old.
- English speaking.
- Unable to consent to study due to cognitive difficulty.
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of virtual reality (VR) hardware and software.
- Sensitivity to flashing light or motion.
- Patients who received anxiolytic drugs or sedatives within the preceding 24 hours.
- Recent stroke.
- Post-transplant patient, or pre-transplant patient with severe illness.
- At the time of in-room virtual reality (VR) administration, patient on ventilator, is receiving BiPAP or CPAP, or other breathing assistance equipment.
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face).
- Non-English speaking.
Eligibility last updated 7/1/22. Questions regarding updates should be directed to the study team contact.
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (EPAS)
A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)
- Focal (partial) onset seizures that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video electroencephalogram (EEG) that captured at least one ictal event.
- Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase.
- Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness.
- Age 18 or older at the time of enrollment.
- Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff.
- Able to use the Patient Programmer with or without the assistance of a caregiver.
- Ability of the subject or legal representative to understand and provide signed consent for participating in the study.
- Willing and available to attend visits as scheduled and to comply with the study protocol.
- Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification).
- Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary.
- Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit.
- Previous diagnosis of psychogenic/non-epileptic seizures.
- Surgical candidate for and willing to undergo resective surgery.
- Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas).
- Diagnosed with a progressive or degenerative neurological disorder affecting the brain.
- Significant medical condition that may impact study participation in the opinion of the investigator.
- Presence of any of the following within 1 year prior to the Enrollment Visit:
- psychiatric illness hospitalization;
- suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state;
- a post-ictal state or a medication.
- Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas).
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators (VNS) are allowed if the subject agrees to have the device turned off for at least 30 days after signing the informed consent and prior to the Enrollment Visit assessments. The VNS generator needs to be explanted prior to or at the time of the DBS neurostimulator implant.
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. This includes administration of any antiplatelet or anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use, chronic aspirin use of greater than 325 mg/day, and any participant with a history of hemorrhagic stroke.
- History of drug or alcohol abuse within the past year.
- Condition or disease that is known to require repeat magnetic resonance imaging (MRIs).
- Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team.
To continue to implant, the data at the end of the CMM Phase must demonstrate that the subject meets these additional inclusion criteria, in addition to verifying the initial eligibility criteria above:
- Experienced an average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 days between seizures.
- Completed at least 70 days of diary information during CMM phase.
- Completed 3-month CMM visit.
- Has Beck Depression Inventory II (BDI-II) score < 20 at 3-month CMM visit and no suicide attempt or other self-harm behaviors within past year (assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) at 3-month CMM visit).
- If female, has a negative pregnancy test and if sexually active continues using a reliable form of birth control, is surgically sterile, or is at least 2 years post-menopausal.
Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery - ENCASE II (ENCASE II)
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE II)
1. Subjects who are able to provide written informed consent prior to participating in
the clinical investigation.
2. Subjects who are ≥ 18 years old.
3. Subjects who are able to comply with the follow-up or other study requirements.
4. Subjects wo are planned for elective surgery including a trepanation to reach the
subdural infratentorial space (with lower limit of incision defined as the lower edge
of C2) in whom a dural incision will be closed.
5. Female subjects of child bearing potential must agree to use a form of contraception
from the time of signing the informed consent form through 90 days post-surgery.
1. Subjects with surgical wound classification Class I/Clean.
2. Subjects with minimally 5 mm of dural space surrounding dural opening.
1. Female subjects who are pregnant or breastfeeding.
2. Subjects with an assumed impaired coagulation due to medication or otherwise.
3. Subjects suspected of an infection requiring antibiotics.
4. Subjects with any type of dural diseases in planned dural closure area.
5. Subjects requiring re-opening of planned surgical area within 90 days after surgery.
6. Subjects with a known allergy to any of the components (Lactide-Caprolactone
co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl
Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
7. Subjects who previously received a LIQOSEAL®.
8. Subjects who previously participated in this study or any investigational drug or
device study within 30 days of screening.
9. Subjects with a presence of hydrocephalus.
10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe
claustrophobia, injured by a metallic object that was not removed, cochlear (ear)
implants, metallic implants [e.g. knee replacement].
1. Subjects in whom elevation of PEEP has a potential detrimental effect.
2. Subjects who will require a CSF drain, electrodes or other devices passing the dural
layer or extra to intracranial bypass surgery.
3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or
autologous material other than galea.
4. Subjects in whom no intra-operative CSF leakage is present after primary closure of
the dura mater with elevation of PEEP.
5. Subjects who after primary closure (including galea, if applicable) of the dura mater
have a gap > 3 mm.
6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.
Prospective Assessment of Changes in Plasma Biomarkers in Patients with Gliomas Receiving Standard Therapy
A Study to Assess Metabolic Changes in the Blood with Standard Treatment in Patients with Gliomas
- Adult patients, ≥ 18 years of age.
- Patients with histopathologic or molecular confirmation of either IDH-mutant diffuse astrocytoma or IDH-mutant anaplastic astrocytoma.
- Patients who will be proceeding to receive routine standard of care treatment (radiation with concurrent oral temozolomide) at Mayo Clinic, Rochester.
- Patients who have previously received any adjuvant therapy (radiation, chemotherapy, investigational) directed towards the glioma.
- Patients who have been previously treated with Gliadel wafers.
A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
- Male or female at least 18 years of age at the time of giving informed consent.
- Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
- Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
- Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
- Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (e.g., barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
- Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.
- Mechanical valve in any position other than aortic valve.
- Any cardiac surgery in the three months (90 days) prior to enrollment.
- Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
- Known hypersensitivity or other contraindication to apixaban.
- On dialysis or a creatinine clearance < 25 mL/min.
- Ischemic stroke or intracranial hemorrhage within 3 months.
- Active pathological bleeding at the time of screening for enrollment.
- Active endocarditis at the time of screening for enrollment.
- Pregnant, plan to become pregnant, or are breast feeding.
- On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
- History of non-compliance with recommended monthly INR testing.
Transplant Caregiver (CG) Research Registry
- Solid organ transplant candidates (18 years or older) on deferred, active, or inactive transplant waiting lists.
- Nominated adult caregivers (18 years or older) of solid organ transplant patients listed for deceased donor solid organ transplantation.
- CG identified in the electronic medical record.
- Individuals unwilling to provide consent.
- Patients or CG unable to complete questionnaires or consents due to limited English proficiency.
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation
A Study to Evaluate the Long-Term Effectives on ALS Disease Progression of BIIB067
- Must have diagnosis of SOD1-ALS, and must have completed the End of Study Visit for either Parts A, B, or C of Study 233AS101 (NCT02623699) (i.e., were not withdrawn).
- If taking riluzole, must be receiving a stable dose for ≥ 30 days prior to Day 1.
- For participants of childbearing potential must agree to practice effective contraception during the study and be willing and able to continue contraception for 5 months after their last dose of study treatment.
- Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.
- Participants from Study 233AS101 Parts A and B must have a washout ≥ 16 weeks between the last dose of study treatment received in Study 233AS101 and the first dose of BIIB067 received in the current Study 233AS102.
- If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1.
- Edaravone may not be administered on dosing days during this study.
- History of allergies to a broad range of anesthetics.
- Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally and could place a participant at an increased risk for bleeding during or after a Lumbar Puncture (LP) procedure. These risks could include, but are not limited to, anatomical factors at or near the LP site (e.g., vascular abnormalities, neoplasms, or other abnormalities) and underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease).
- Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter.
- Prior or current treatment with small interfering ribonucleic acid (RNA), stem cell therapy, or gene therapy.
- Treatment with another investigational drug, biological agent (excluding BIIB067), or device within 1 month or 5 half-lives of study agent, whichever is longer.
- Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.
- Female participants who are pregnant or currently breastfeeding.
- Current enrollment in any other interventional study.
- Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis(N4-methylthiosemicarbazone)) or pyrimethamine.
- Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) or vaccination (defined as positive anti-HBs) are eligible to participate in the study.
- Presence of an implanted intravenous port/catheter.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
A Study to Evaluate Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
- Patients 18-95 years old.
- Diagnosed with sellar and suprasellar masses.
- Undergo neurosurgical procedure at Mayo Clinic Rochester.
- Patients under 18 or over 95 years old.
- Patients with preexisting central diabetes insipidus (CDI).
Cohort Study of Pancreatic Cancer Risk
A Study of Pancreatic Cancer Risk
- An individual who has previously consented to the Biospecimen Resource for Pancreas Research (Substudy #1 – Pancreatic Disease Cases) – IRB 354-06 who does not have pancreas disease but does have a family history of pancreas disease or (Substudy #2 Family Studies) – IRB 355-06.
- Individual who does not have a personal history of pancreatic cancer and meets one of the following:
- Has relatives in family that contains pancreatic cancer, and carries a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53; OR
- Is a first- or second-degree blood relative of an individual with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and this PDAC patient has a germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53; OR
- Is a first- or second-degree blood relative of an individual with a germline mutation in one of these genes and where the mutation carrier is also a first-degree relative to a PDAC case; OR
- Is a blood relative to a PDAC patient in a family that contains three blood relatives (all maternal side or all paternal side) with PDAC;
- Age 50 or older; OR
- Or within 10 years of the age of diagnosis of the youngest PDAC blood relative.
- Individual with a valid United States mailing address.
- Individual who has a personal history of PDAC.
- Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e., leukemia or lymphoma).
- Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness.
- Individual who is non-English speaking
- Individual who is a prison inmate.
Eligibility last updated 10/6/21. Questions regarding updates should be directed to the study team contact.
Analysis of Waste Specimens from the Eye After Surgery
A Study to Analyze Waste Specimens from the Eye After Surgery
- All patients undergoing surgery by Dr. Bakri.
- Any waste tissue will be saved.
Trial Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD) (TRC-PAD)
TRC-PAD Program: In-Clinic Trial-Ready Cohort
- Provision of signed and dated informed consent form.
- Stated availability and willingness to comply with all study procedures until referred to a clinical trial.
- Age 50-85 (inclusive).
- Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia.
- Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function.
- In good general health as evidenced by medical history.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Fluent in English or Spanish.
- For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan.
- Completed six grades of education or has a good work history.
- Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center.
- Treatment with another anti-amyloid investigational drug or other intervention within 12 months.
- Enrolled in another interventional clinical trial within the last 12 weeks.
- Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
- History of schizophrenia (DSM V criteria).
- History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria).
- Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
- History within the last 3 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
- Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
- Clinically significant abnormalities in screening laboratories or ECG.
- For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin).
- Participants whom the Site PI deems to be otherwise ineligible.
- Site PIs should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC would be appropriate.
Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director and Coordinating Center.
Long Term Follow-Up of Participants Treated with GSK Adoptive Cell Therapies
Long Term Follow-Up of Subjects Exposed to GSK3377794
- Subjects who have received at least one dose of GSK3377794 in the interventional study.
- Subjects who have either completed the interventional study or have withdrawn from it.
- Male or female subjects.
- Capable of giving signed informed consent prior to the study participation.
Minimal Residual Disease in Chronic Lymphocytic Leukemia
A Study to Evaluate Minimal Residual Disease in Chronic Lymphocytic Leukemia
- Age 18+ Years Old.
- Diagnosis of Chronic Lymphocytic Leukemia (B-CLL).
Epidural Spinal Stimulation User Experience Survey for Individuals with Paralysis Due to Spinal Cord Injury
A Study to Survey Epidural User Experience for Individuals with Spinal Cord Injury Paralysis
- Individuals with spinal cord injury who have received an epidural spinal stimulation implant for return of functional return.
- Individuals who have received an epidural spinal stimulation implant but have since had it removed.
- English speaking individuals.
- Individuals with spinal cord injury who have received an epidural spinal stimulation implant for pain.
- Non-English speaking individuals.
Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
A Study to Determine Baseline Levels for Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
- Age 18+ years of age.
- Able to give informed consent.
Prostate Cancer Patients
- Patients with intermediate-risk, high-risk or very-high risk prostate cancer (≥ Grade Group 2).
- Patients scheduled to undergo open radical prostatectomy (ORP).
- Patients scheduled to undergo conventional laparoscopic radical prostatectomy (LRP).
- Patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RALP).
- Patients scheduled to undergo external beam radiation therapy (EBRT).
- Patients treated for nephrolithiasis (Extracorporeal Shock Wave Lithotripsy/Surgery).
Prostate Cancer patients
- Unable or unwilling to provide informed consent.
- On hormone therapy (Casodex, GnRH agonist/antagonist).
- Patients with Benign Prostatic Hyperplasia (BPH).
- Active (non-skin) malignancy within the past 5 years excluding prostate cancer.
- Unable or unwilling to provide informed consent.
- History of Benign Prostatic Hypertrophy (BPH).
- Active (non-skin) malignancy within the past 5 years including prostate cancer.
Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.
TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease (TOPAZ)
A Study to Evaluate Zoledronic Acid for Fracture Prevention in Parkinson's Disease Patients
- Men and women age 65 years or older.
- Current PD diagnosis with symptoms severity at Hoehn & Yahr (H&Y) stage 1-4 based on an expert assessment (movement disorders neurologist report or telemedicine evaluation).
- Willing and able to continue in follow-up for at least 2 years.
- Willing and able to provide informed consent.
- History of hip fracture.
- Any use of a bisphosphonate drug within the last 12 months.
- Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last 6 months.
- Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months.
- Non-ambulatory; i.e., unable to walk without assistance of another person.
- Undergoing kidney dialysis.
- A diagnosis of multiple myeloma or Paget's disease.
- Unable to speak or read English sufficiently to complete informed consent.
- Any other criteria, which would make the patient unsuitable to participate in this study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol addiction).
MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR (TIF vs LNF)
A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia
•80 years of age.
- Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
- Pathologic reflux while off PPI based on Lyon criteria by either of the following:
- Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
- Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
- Commitment to long-term study.
- Ability to give consent individually or by a legally authorized representative.
- Hiatal hernia > 5 cm.
- Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
- Pregnancy (in females) at time of procedure.
- Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
- Subjects requiring mesh treatment at time of procedure.
- Provider discretion.
- BMI > 35.
LS1981: Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL) or Histiocytic/Dendritic Cell Neoplasms
Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms
- Biopsy-proven relapsed and/or refractory non-Hodgkin lymphoma or histiocytic/dendritic
cell neoplasms. Relapsed is defined as a relapse that occurred after having a response
to the last therapy that lasted > 26 weeks. Refractory is no response (stable disease
or progressive disease while on therapy) or relapse within 6 months. Refractoriness to
autologous stem cell transplant will be defined as disease progression within 52 weeks
- Most recent tumor biopsy must be < 26 weeks prior to registration
- Measurable or assessable disease: Measurable disease is defined as measurable by
computed tomography (CT) (dedicated CT or the CT portion of a positron emission
tomography [PET]/CT) or magnetic resonance imaging [MRI]: To be considered measurable,
there must be at least one lesion that has a single diameter of >= 1.5 cm. NOTE: Skin
lesions can be used if the area is >= 1.5cm in at least one diameter and photographed
with a ruler. Patients with assessable disease by PET/CT are also eligible as long as
the assessable disease is biopsy proven lymphoma
- Patients must have previously been treated with at least 2 lines of therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1,000/mm^3 (obtained =< 14 days prior to
- Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)
- Hemoglobin >= 8.5 g/dL (may be transfused to reach criteria) (obtained =< 14 days
prior to registration)
- Total bilirubin < 2 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN
with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's
syndrome) (obtained =< 14 days prior to registration)
- Aspartate transaminase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x
ULN (obtained =< 14 days prior to registration)
- Calculated creatinine clearance must be >= 35 ml/min using the Cockcroft Gault formula
(obtained =< 14 days prior to registration)
- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only
- Female of childbearing potential (FCBP*) must commit to take highly effective
contraceptive precautions** without interruption during the study and continue for at
least 12 weeks after the last dose of selinexor and CS. FCBP must refrain from
breastfeeding and donating oocytes during the course of the study. Males must use an
effective barrier method of contraception without interruption during the study and
continue for at least 12 weeks after the last dose of selinexor and CS. They must
refrain from donating sperm during the study participation.
- *FCBP defined as sexually mature women who have not undergone bilateral tubal
ligation, bilateral oophorectomy, or hysterectomy; or who have not been
postmenopausal (i.e., who have not menstruated at all) for at least 1 year
- Highly effective forms of birth control are methods that achieve a failure
rate of less than 1% per year when used consistently and correctly. Highly
effective forms of birth control include: hormonal contraceptives (oral,
injectable, patch, and intrauterine devices), male partner sterilization, or
total abstinence from heterosexual intercourse, when this is the preferred
and usual lifestyle of the patient NOTE: The double-barrier method (e.g.,
synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream,
or gel), periodic abstinence (such as calendar, symptothermal,
post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea
method, and spermicide-only are not acceptable as highly effective methods
- 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 per protocol for Pharmacokinetics
(PKs) and banking, and mandatory tissue samples for correlative research. NOTE: If an
institution is not able to provide the tissue, it does not cause the patient to be
ineligible; however, the collection of these tissues is strongly recommended
- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
- Pregnant women
- Nursing women
- 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
- Patients known to have active hepatitis B, or C infection, or known to be positive for
hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg)
(hepatitis B virus [HBV] surface antigen). Patients known to be human immunodeficiency
virus (HIV) positive, except those with CD4+ T-cell (CD4+) counts >= 350 cells/uL and
on an established antiretroviral therapy (ART) for at least twelve weeks and have an
HIV viral load less than 400 copies/mL prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Life expectancy of < 6 months
- Active gastrointestinal (GI) dysfunction interfering with the ability to swallow
tablets, or any GI dysfunction that could interfere with absorption of study treatment
- Known intolerance to or contraindications for choline salicylate therapy. Patients
with known allergy to acetylsalicylic acid (ASA) are not eligible
- Prior exposure to a selective inhibitors of nuclear export (SINE) compound, including
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm
- Active second malignancy requiring treatment that would interfere with the assessment
of the response of the lymphoma to this protocol therapy. Patients with treated
malignancies on hormonal therapy (for example breast or prostate cancer) are eligible
- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks
prior to registration. NOTE: Exception: patients on any BTK inhibitor (ibrutinib,
zanabrutinib, acalabrutinib, etc), or venetoclax, or corticosteroids (any dose) may
continue therapy up until the new regimen has started at investigator discretion.
After the start of protocol therapy, corticosteroids can be used at investigator's
discretion and tapered to lowest possible dose
- Active graft versus (vs.) host disease (after allogeneic stem cell transplantation) at
- Major surgery (including bowel resection) =< 3 weeks prior to registration
- Must not be currently eligible or have declined high-dose therapy with autologous stem
cell transplantation rescue or chimeric antigen receptor (CAR)-T cell therapy
- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
- Known active central nervous system (CNS) lymphoma. Patients with previous CNS
involvement can enroll if the CNS component is inactive
- Patients who are on active anticoagulant therapy with direct oral anticoagulants
(DOACs), aspirin or warfarin are not eligible due to potential bleeding. EXCEPTIONS:
Patients who are on aspirin (81 mg) for primary prevention of cardiovascular disease
can enroll, but the ASA needs to be held while on this protocol therapy
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
CureGN: Cure Glomerulonephropathy Network
A Registry and Biospecimen Collection to Advance the Diagnosis and Care of Patients with Glomerular Diseases
- Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
- First diagnostic kidney biopsy within 5 years of study enrollment.
- Access to first kidney biopsy report and/or slides.
- All ages.
- Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
- Informed consent and, where age appropriate, informed assent.
- ESKD, defined as chronic dialysis or kidney transplant.
- Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
- Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
- Diabetes mellitus;
- Histopathologic findings of diabetic glomerulosclerosis;
- Systemic lupus erythematosus;
- HIV infection;
- Active malignancy, except for non-melanoma skin cancer;
- Active Hepatitis B or C infection, defined as positive viral load.