A Comprehensive Translational Research Platform for Colorectal Cancer (CRC Platform)
A Comprehensive Translational Research Platform for Colorectal Cancer
- Age ≥ 18 years.
- Cytologically or histologically confirmed colorectal cancer.
- Undergoing biopsy or surgical procedures as part of routine clinical care.
- Individuals < 18 years.
- Vulnerable patients.
- Unable to provide informed consent.
Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.
MC220301 Targeted Prevention of Post-Partum-Related Breast Cancer
Study of Aspirin for the Prevention of Post-partum-Related Breast Cancer
Inclusion Criteria
•Pre-Registration:
- Age ≥ 18 years and ≤ 45 years of age.
- Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy.
- Had a live birth ≤ 5 years prior to pre-registration.
- Pre-menopausal.
- Provide written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Willingness to provide mandatory blood and urine specimens for correlative research.
- Willingness to provide mandatory tissue specimens for correlative research.
Inclusion Criteria
•Registration:
- Age ≥ 18 years and ≤ 45 years of age.
- Histological confirmation of benign breast disease (i.e., no evidence of DCIS or invasive cancer).
- Registration must be completed ≤ 30 days after pre-registration biopsy performed for this study.
- Hemoglobin ≥ 9.0 g/dL (obtained ≤ 30 days prior to registration).
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to registration.
- Serum creatinine ≤ 2.0 mg/dl (obtained ≤ days prior to registration).
- Negative pregnancy test done ≤ 7 days prior to registration.
- Willing to use contraception while on treatment.
- Provide written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Willingness to provide mandatory blood and urine specimens for correlative research.
- Willingness to provide mandatory tissue specimens for correlative research.
- Willing to return to enrolling institution for follow-up.
Exclusion Criteria
•Pre-Registration:
- History of breast cancer including ductal breast carcinoma in situ (DCIS).
- Received systemic treatment for any other cancer at any time.
- Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within ≤ 5 days prior to pre-registration and no more than four doses within ≤ 30 days prior to pre-registration).
- Currently taking other agents for the prevention of breast cancer.
- Currently taking anticoagulants.
- Contraindication for aspirin use.
Exclusion Criteria
•Registration:
- No research tissue collected during pre-registration biopsy performed for this study.
- Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
- NOTE: no doses within ≤ 5 days prior to registration and no more than four doses within ≤ 30 days prior to registration.
- Co-morbid illnesses/conditions 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.
- Any contraindication to aspirin use including but not limited to:
- Bleeding disorders (e.g., hemophilia);
- Stomach or intestinal bleeding ≤ 6 months prior to registration;
- Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs).
- Currently taking anticoagulants.
- Any malignancy requiring systemic therapy.
- Currently pregnant or planning to become pregnant in the next 90 days.
- Post-menopausal:
- Prior bilateral surgical oophorectomy; or
- No menses for > 1 year with estradiol levels within postmenopausal range, according to institutional standard.
Eligibility last updated 1/3/23. Questions regarding updates should be directed to the study team contact.
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia (SCOPE-L)
Specialty Compared to Oncology Delivered Palliative Care for Treating Acute Myeloid Leukemia
Inclusion Criteria
•Patient:
- Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
- Patients with new diagnosis ≥ 60 years of age;
- An antecedent hematologic disorder;
- Therapy related-disease;
- Relapsed or primary refractory AML.
- Receiving treatment with either:
- intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or
- hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.
Inclusion Criteria
•Caregiver:
- Adult (≥ 18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.
Exclusion Criteria
•Patient:
- Patients with a diagnosis of acute promyelocytic leukemia (APML).
- Patients with AML receiving supportive care alone.
- Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures.
Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.
(CAMPERR) cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)
cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Case
- Newly diagnosed (within 90 days) with cancer or a recurrence of a cancer diagnosed > 5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical,
Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple
Myeloma.
- Able and willing to provide informed consent.
- ≥ 40 years of age.
Case
- Currently receiving any treatment for cancer.
- Currently taking any demethylating agents/DNA hypomethylating agents.
- Simultaneously diagnosed with two or more invasive cancers.
- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years.
- Currently diagnosed with any chronic hematopoietic cancer (e.g., chronic CLL) in addition to the index cancer.
- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g., MGUS) in addition to the index cancer.
- Women who are known to be pregnant (self-reported).
Control
- Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed).
- Able and willing to provide informed consent.
- ≥ 40 years of age.
Control
- Currently receiving any treatment for cancer.
- Currently taking any demethylating agents/DNA hypomethylating agents.
- Women who are known to be pregnant (self-reported).
Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
Inclusion Criteria
•Obese Subjects with Type 2 Diabetes:
- Age ≥ 25 or ≤ 65 years.
- HbA1c ≤ 8.5% (type 2 diabetic subjects).
- HbA1c ≤ 6.5% (obese and lean subjects).
- BMI ≥ 28 Kg/M^2 (Obese subjects with and without type 2 diabetes).
- BMI ≤ 25 Kg/M^2 (Lean subjects without type 2 diabetes).
- Use of sulfonylureas or metformin only (type 2 diabetec subjects).
- For female subjects: negative pregnancy test at the time of enrollment or study.
- No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- No active systemic illness or malignancy.
- No symptomatic macrovascular or microvascular disease.
- No contraindications to MRI (e.g., metal implants, claustrophobia).
- Hematocrit > 35%.
- TSH > 0.4 or < 5.5.
- Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.
Exclusion Criteria
•Obese Subjects with Type 2 Diabetes:
- Age ≤ 25 or ≥ 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- HbA1c ≥ 8.5%.
- BMI ≤ 28 Kg/M^2.
- Use of insulin or agents other than sulfonylureas or metformin.
- For female subjects: positive pregnancy test at the time of enrollment or study.
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Contraindications to MRI (e.g., metal implants, claustrophobia).
- Hematocrit < 35%.
- TSH < 0.4 or > 5.5.
- Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
Inclusion Criteria
•Obese Subjects without Type 2 Diabetes:
- BMI ≥ 28 Kg/M^2.
- > 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.
Exclusion Criteria
•Obese Subjects without Type 2 Diabetes:
- Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
- HbA1c ≥ 6.5%.
- BMI ≤ 28 Kg/M^2.
- Use of any glucose-lowering agents including metformin or sulfonylureas.
- For female subjects: positive pregnancy test at the time of enrollment or study.
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Contraindications to MRI (e.g., metal implants, claustrophobia).
- Hematocrit < 35%.
- TSH < 0.4 or > 5.5.
- Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
Inclusion Criteria - Lean Subjects without Diabetes:
- Age ≥ 25 or ≤ 65 years (match subjects with T2DM).
- BMI ≤ 25 Kg/M^2).
Exclusion Criteria
•Lean Subjects without Diabetes:
- Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
- HbA1c ≥ 6.5%.
- BMI ≥ 25 Kg/M^2.
- Use of any glucose-lowering agents including metformin or sulfonylureas.
- For female subjects: positive pregnancy test at the time of enrollment or study.
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Contraindications to MRI (e.g., metal implants, claustrophobia).
- Hematocrit < 35%.
- TSH < 0.4 or > 5.5.
- Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
- Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.
Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.
Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young: BTTRFLY Project (BTTRFLY)
Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
- Patients with a diagnosis of soft tissue sarcoma.
- Unable or unwilling to provide informed consent
Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
- The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable.
- The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
- In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.
- None.
Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.
Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)
Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension
- Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
- Age ≥ 18 years.
- On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
- NYHA class II-III symptoms.
- able to complete a six-minute walk test.
- Patients experiencing syncope or exertional syncope.
- Patients not experiencing exertional dyspnea.
- Inability to walk.
- Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).
Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
First in Human Study of TORL-1-23 in Participants With Advanced Cancer
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the
acute toxicities of previous therapy, except treatment-related alopecia or laboratory
abnormalities otherwise meeting eligibility requirements
- Received prior chemotherapeutic, investigational, or other therapies for the treatment
of cancer within 14 days with small molecule and within 28 days with biologic before
the first dose of TORL-1-23
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,
uncontrolled infection
- History of significant cardiac disease
- History of myelodysplastic syndrome (MDS) or AML
- History of another cancer within 3 years before Day 1 of study treatment, with the
exception of basal or squamous cell carcinoma of the skin that has been definitively
treated. A history of other malignancies with a low risk of recurrence, including
appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate
cancer with a Gleason score less than or equal to 6, are also not excluded
- If female, is pregnant or breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.
Reducing Opioids after Percutaneous Stone Surgery (ROPES)
Reducing Opioid Prescription After Kidney Stone Removal Surgery
- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
- Adults ≥ 18 years old.
- Ability to receive and respond to electronic text messages.
- Unable or unwilling to provide informed consent.
- Patients who require Intensive Care Unit admission after surgery.
- Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.
Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.
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
- 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.
- 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.
The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions
The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions
Inclusion Criteria
•Patients:
- Adults ≥ 18 years
- Appointment to discuss osteoporosis management
Exclusion Criteria
•Patients:
- Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment)
Inclusion Criteria
•Clinicians:
- Clinicians who meet with patients to discuss osteoporosis management.
Exclusion Critieria
•Clinicians:
- None
Inclusion Critieria
•PAG Members:
- Adults ≥ 18 years
- Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)
Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.
Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure with preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial (CAMEO SEMA)
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
Subjects are eligible to be randomized in the study only if all of the following inclusion criteria and none of the exclusion criteria apply. To mirror the STEP-HFpEF trials CAMEO-SEMA will utilize essentially the same entry criteria, except for an EF cutoff. CAMEO-SEMA will use an EF value of ≥ 50% (rather than ≥ 45%) to define HFpEF, to harmonize with the recently published universal definition of HFpEF.59.
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Age ≥ 18 years at the time of signing informed consent.
- BMI ≥ 30.0 kg/m^2.
- NYHA Class II-IV.
- LVEF ≥ 50 % within the preceding year.
- No hospitalizations due to heart failure in the preceding 30 days.
- At least one of the following:
- Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise;
- If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):
- Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
- PA systolic pressure > 35 mmHg;
- Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
- LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.
- Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):
- Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
- PA systolic pressure > 35 mmHg;
- LA enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
- LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm;
- Ongoing use of diuretic therapy for at least 30 days prior to screening.
Cardiovascular-related:
- Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- Systolic blood pressure > 160 mmHg at screening.
- Planned coronary, carotid or peripheral artery revascularization.
- Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
- Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.
- Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome, lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice. This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive. Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.
Obesity-related:
- Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
Glycemia-related:
- HbA1c ≥ 6.5% based on latest available value from medical records, no older than 3 months or if unavailable at local measurement at screening.
- History of type 1 or type 2 diabetes (history of gestational diabetes is allowed).
- Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.
General health and safety:
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Presence of acute pancreatitis within the last 180 days prior to screening.
- History or presence of chronic pancreatitis.
- End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
- Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
- Known or suspected hypersensitivity to trial product(s) or related products.
- Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.
- Receipt of any investigational medicinal product within 30 days before screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
- Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
- The criteria will be assessed at the investigator’s discretion unless otherwise stated.
Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.
A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
- ≥ 16 years of age at the time of obtaining informed consent
- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
- At least one PET-avid measurable lesion according to Modified Lugano Criteria after
the last line of therapy.
- Confirmed histological diagnosis of active relapse/refractory cHL
- Failed at least 2 prior lines of systemic therapy.
- No previous treatment with anti-TIM-3.
- Adequate organ and bone marrow function
- Non-pregnant women and willingness of female patients to avoid pregnancy or male
participants willing to avoid fathering children through highly effective methods of
contraception
- Minimum body weight ≥ 40 kg for all participants.
- Unresolved toxicities of ≥ Grade 2 from prior therapy
- Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy
- Patients with CNS involvement or leptomeningeal disease.
- History of organ transplantation (e.g., stem cell or solid organ transplant).
- Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose
of study intervention.
- Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B,
chronic or active hepatitis C, active COVID-19 infection
- History of arrhythmia which is requires treatment, symptomatic or uncontrolled atrial
fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
- Uncontrolled intercurrent illness.
- Active or prior documented pathologically confirmed autoimmune or inflammatory
disorders.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation
pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- Other invasive malignancy within 2 years prior to screening
- Congenital long QT syndrome or history of QT prolongation associated with other
medications that cannot be changed or discontinued based on a cardiologist assessment
- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of study intervention
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal
therapy for cancer treatment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 4/11/23. Questions regarding updates should be directed to the study team contact.
Natural History of Myhre Syndrome (MS)
Examining the Natural History of Myhre Syndrome
- 18 years or older.
- Diagnosis of Myhre Syndrome.
- Individuals < 18 years of age.
Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.
Refractory Inflammatory Seizures in Kids (RISK) (RISK)
Refractory Inflammatory Seizures in Kids (RISK)
Inclusion Criteria
•RISK Primary
- New onset refractory status epilepticus with or without fever.
- Failure to respond to 2 or more first-line anti-seizure drugs.
- Age 0 to 18 years.
- Etiology for status epilepticus unknown:
- No history of pre-existing epilepsy;
- No pre-existing major developmental impairment;
- No evidence of prodromal dyskinesia, hallucinations, or psychiatric symptoms;
- No evidence of structural, cerebrovascular, neoplastic, metabolic, traumatic, or toxic etiology.
Inclusion Criteria
•RISK Primary
- Epileptiform abnormality on EEG.
- Seizure frequency at least weekly.
- Failure to respond to 2 or more first-line anti-seizure drugs.
- Age 0 to 18 years.
- Clinical and electrophysiological profile not consistent with:
- self-limited focal epilepsy syndrome;
- unifocal epilepsy.
- Normal 3T epilepsy protocol MRI (if available).
- Normal epilepsy panel or no evidence of known epilepsy mutations by whole exome sequencing (if available).
- No evidence of autoimmune, cerebrovascular, neoplastic, metabolic, traumatic, or toxic etiology.
Inclusion Criteria
•RISK Retrospective Recruitment Inclusion Criteria (~100 patients):
- Prior diagnosis consistent with NORSE or DRE.
- No evidence of autoimmune, infectious, structural, cerebrovascular, neoplastic, metabolic, or toxic etiology.
- Negative genetic epilepsy panel.
- Note: No exclusions based on disease-modifying therapies, including immunomodulatory or immunosuppressive treatments (e.g., IV corticosteroids, plasma exchange, intravenous immunoglobulin, and anti-cytokine drugs such as anakinra or tocilizumab).
- Validated autoimmune disorder.
- Smoker.
- Pregnant.
- Weight < 9 kg.
Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.
Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient TJA
- Adult patients age ≥ 18.
- Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.
- Individuals < 18 years of age.
Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer (MNCCTN023)
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Inclusion Criteria:
- Age ≥ 18 years.
- Ability to read and write in English.
- Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
- Treatment plan includes chemotherapy.
- Able to provide written voluntary consent before performance of any study related procedure.
- Aim 1 only: after completion of initial chemotherapy.
- Aim 2 only: prior to starting chemotherapy.
- Inability to provide informed consent.
- Exposure to chemotherapy prior to ovarian cancer diagnosis.
- Life expectancy < 3 months or in hospice care or nursing home.
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer (MNCCTN023)
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Inclusion Criteria:
- Age ≥ 18 years.
- Ability to read and write in English.
- Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
- Treatment plan includes chemotherapy.
- Able to provide written voluntary consent before performance of any study related procedure.
- Aim 1 only: after completion of initial chemotherapy.
- Aim 2 only: prior to starting chemotherapy.
- Inability to provide informed consent.
- Exposure to chemotherapy prior to ovarian cancer diagnosis.
- Life expectancy < 3 months or in hospice care or nursing home.
Dexamethasone in Total Knee Arthroplasty: What Dose Should We Be Giving Patients Intraoperatively?
Dexamethasone in Total Knee Arthroplasty
- Age ≥ 18 years.
- Primary total knee arthroplasty.
- Patients staying at least one night in the hospital after surgery.
- Individuals < 18 years.
- Same day discharge.
- Revision or partial total knee arthroplasty.
- Corticosteroid use within 3 months prior to surgery.
- Inflammatory arthritis
- Current systemic fungal infection.
- Renal or liver failure.
- Prior adverse reaction to corticosteroid.
- Primary TKA requiring hardware removal.
10476 / A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
- Pathologically confirmed biliary tract cancer, having received at least 1 prior line
of systemic therapy, and received no more than 2 prior lines of therapy in the
metastatic setting (disease recurrence =< 6 months from the last dose of adjuvant
therapy in resected patients will be considered the first line of therapy)
- Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma
(EHC), and gallbladder carcinoma (GBC), but not Ampulla of Vater cancers
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1
- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) in patients < 18 years
of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
- Absolute neutrophil count >= 1,500/mcL
- Hemoglobin >= 9.0 g/dl
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Patients with
known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
3 x institutional ULN
- Serum creatinine =< 1.5 x institutional ULN OR
- Creatinine clearance > 30 mL/min/1.73 m^2 (calculated by Cockcroft-Gault method) for
patients with creatinine levels above institutional normal
- Albumin >= 3.0 g/dL
- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This
applies only to patients who do not receive therapeutic anticoagulation; patients
receiving therapeutic anticoagulation, such as low-molecular-weight heparin or
warfarin, should be on a stable dose)
- Creatine kinase (CK)/creatine phosphokinase (CPK) < 5 x ULN
- Oxygen saturation >= 92% on room air
- Left ventricular ejection fraction > 50%
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
- Patients must be willing to undergo 2 sets of core needle biopsies. If possible,
biopsied sites should be different than those used for measurable disease/RECIST
measurements, but this is not mandatory
- Patients must have an estimated life expectancy of greater than 3 months
- Patients must be able to swallow pills
- Patients should not have evidence of retinal pathology on ophthalmologic examination;
or neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular
macular degeneration
- The effects of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) on the developing
human fetus are unknown. For this reason, women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and 5
months after the last dose of atezolizumab. Should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately. Men treated or enrolled on this protocol
must also agree to use adequate contraception prior to the study, for the duration of
study participation, and 5 months (150 days) after completion of atezolizumab,
cobimetinib, and CDX-1127 (varlilumab) administration
- Ability to understand and the willingness to sign a written informed consent document
- Patients with prior allogeneic bone marrow transplantation within the past 5 years or
prior solid organ transplantation at any point
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events (other than alopecia or neuropathy) due to agents
administered more than 4 weeks earlier. However, the following therapies are allowed:
- Hormone-replacement therapy or oral contraceptives
- Herbal therapy > 1 week prior to randomization (herbal therapy intended as
anticancer therapy must be discontinued at least 1 week prior to randomization)
- Palliative radiotherapy for bone metastases > 2 weeks prior to randomization
- Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1or other immune checkpoint
inhibitor therapeutic antibodies or pathway-targeting agents. Patients who have only
received previous durvalumab (anti-PD-L1) as part of first line in combination with
gemcitabine and cisplatin (TOPAZ-1 regimen [NCT03875235]) are eligible
- Prior treatment with MEK or ERK inhibitors
- Treatment with any other investigational agent within 4 weeks prior to randomization
- Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to randomization
- Treatment with systemic immunosuppressive medications (including, but not limited to,
prednisone (> 10 mg), cyclophosphamide, tacrolimus, sirolimus, azathioprine,
methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2
weeks prior to randomization.
- Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
- The use of physiologic doses of systemic corticosteroids and mineralocorticoids
(e.g., fludrocortisone) for patients with orthostatic hypotension or
adrenocortical insufficiency is allowed.
- The use of topical and inhaled corticosteroids are allowed due to low systemic
absorption
- Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of
bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is
allowed
- Presence of therapeutically actionable mutation with approved targeted therapy (e.g.
FGFR fusion patients are eligible for study therapy in the 3rd line setting). Patient
must have received somatic mutation testing (tissue or liquid) prior to enrollment
- Clinically significant ascites (palpable on exam, paracentesis in last 3 months,
and/or symptomatic)
- Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS
metastases are excluded, with the following exceptions:
- Patients with asymptomatic treated CNS metastases may be enrolled, provided all
the criteria listed above are met as well as the following:
- Radiographic demonstration of improvement upon the completion of CNS
directed therapy and no evidence of interim progression between the
completion of CNS directed therapy and the screening radiographic study
- No stereotactic radiation or whole-brain radiation within 28 days prior to
randomization
- Screening CNS radiographic study >= 4 weeks from completion of radiotherapy
and >= 2 weeks from discontinuation of corticosteroids
- Follow-up brain imaging 3 months after central nervous system (CNS)-directed
therapy shows no evidence of progression
- History of malignant bowel obstruction
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
Chinese hamster ovary cell products, chimeric, humanized, or other recombinant human
antibodies or fusion proteins
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to atezolizumab, cobimetinib, or CDX-1127 (varlilumab)
- Patients receiving any medications or substances that are considered moderate to
strong inhibitors or inducers of CYP3A and are not able to switch to an alternative
that minimizes interaction potential will ineligible. Coadministration of cobimetinib
with a strong CYP3A4 inhibitor can increase cobimetinib systemic exposure
significantly (e.g. itraconazole increased serum systemic cobimetinib exposure by 6.7
fold). On the other end, coadministration of cobimetinib with a strong CYP3A inducer
may decrease cobimetinib systemic exposure by more than 80% thus reducing its
efficacy. Because the lists of these agents are constantly changing, it is important
to regularly consult a frequently-updated list such as
http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the
Physicians' Desk Reference may also provide this information. As part of the
enrollment/informed consent procedures, the patient will be counseled on the risk of
interactions with other agents, and what to do if new medications need to be
prescribed or if the patient is considering a new over-the-counter medicine or herbal
product
- Patients on mild inhibitors or inducers of CYP3A are allowed
- Patients with a known clinically significant liver disease, including active viral,
alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.
- Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
- Patients who have received immunosuppressive treatment for systemic autoimmune
disease, including, but not limited to, systemic lupus erythematosus, rheumatoid
arthritis, inflammatory bowel disease, vascular thrombosis associated with
antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple
sclerosis, vasculitis, or glomerulonephritis within the last 2 years.
- Patients with a history autoimmune endocrine disorders on stable doses of
physiologic hormone replacement may be eligible.
- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may
be eligible.
- Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would
be excluded) are permitted provided that they meet the following conditions:
- Patients with psoriasis must have a baseline ophthalmologic exam to rule out
ocular manifestations
- Rash must cover less than 10% of body surface area (BSA)
- Disease is well controlled at baseline and only requiring low potency
topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,
fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
- No acute exacerbations of underlying condition within the last 12 months
(not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors; high potency or
oral steroids)
- Patients with history Guillain-Barre syndrome or myasthenia gravis at any point
will not be eligible
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
tomography (CT) scan. History of radiation pneumonitis in the radiation field
(fibrosis) is permitted
- Patients with active tuberculosis (TB) are excluded
- Severe infections within 4 weeks prior to randomization, including, but not limited
to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Signs or symptoms of infection within 2 weeks prior to randomization
- Received oral or intravenous (IV) antibiotics within 2 weeks prior to randomization
- Patients receiving prophylactic/suppressive antibiotics will not be eligible
- Major surgical procedure within 28 days prior to randomization or anticipation of need
for a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before randomization or
anticipation that such a live, attenuated vaccine will be required during the study
and up to 5 months after the last dose of atezolizumab.
- Influenza vaccination should be given during influenza season only (approximately
October to March). Patients must not receive live, attenuated influenza vaccine
within 4 weeks prior to Randomization or at any time during the study.
- Coronavirus disease 2019 (COVID-19) vaccination is not exclusionary but should be
administered at least 7 days before study start
- Patients with psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant women are excluded from this study because one or more study agents have the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with atezolizumab, cobimetinib, and CDX-1127 (varlilumab), breastfeeding should
be discontinued if the mother is treated with atezolizumab, cobimetinib, and CDX-1127
(varlilumab)
- Patients who are using ethinyl estradiol containing oral contraceptives when
administered concomitantly with cobimetinib, are excluded due to increased risk of
venous thromboembolism
- Patients with a history of clinically significant cardiac dysfunction, including the
following:
- Left ventricular ejection fraction (LVEF) below institutional lower limit of
normal (LLN) or below 50%, whichever is lower
- Current unstable angina
- Current symptomatic congestive heart failure (CHF) of New York Heart Association
class 2 or higher
- Uncontrolled hypertension >= grade 2 (patients with a history hypertension
controlled with anti-hypertensives to =< grade 1 are eligible).
- Uncontrolled arrhythmias
- Myocardial infarction, severe/unstable angina, symptomatic chronic heart failure
(CHF), cerebrovascular accident or transient ischemic attack within the previous
6 months
- History of treatment with cardiotoxic agents
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.
Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot
Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot
- Patients with TOF or TOF-related variants.
- Age ≥ 18 years.
- Planned transcatheter valve placement in native RVOT.
- Individuals < 18 years.
- Non-TOF related variants (i.e., pulmonary stenosis, PA-IVS, etc.).
- Prior catheter or surgical ablation of ventricular tachycardia (VT).
Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.
Minnesota Regional SCIMS (SCIMS)
Spinal Cord Injury Model Systems for Minnesota Region (SCIMS)
- Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
- Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
- Admission to the system within one year of injury.
- Discharge from the System Rehab as:
- Having completed inpatient acute rehabilitation;
- Deceased.
- Signed informed consent and HIPAA authorization forms.
- Reside in the geographic catchment area of the system at the time of the injury. Patients may be injured outside of the catchment area.
- A US citizen or non-US citizen who is expected to stay in the catchment area.
- Must not have previously been treated at another model system for the injury.
- Ensures that patients are enrolled into the database by only one model system.
- Must not have completed an organized rehabilitation program prior to the admission to the system.
Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.
Assessing the Experiences of LGBTQ patients in the ICU (LGBT in ICU)
Assessing the Experiences of LGBTQ Patients in the ICU
- Is 18 years old or older.
- Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
- Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.
- Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.
Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.
A Phase 3, Multicenter, Randomized, Controlled, Open-Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
- Adults ≥18 years of age;
- Patients who are anticipated to require >12 hours of invasive mechanical ventilation
and continuous sedation in the ICU; and
- Receipt of continuous sedation due to clinical need for sedation to RASS <0.
- Need for RASS -5;
- Sedation for invasive mechanical ventilation immediately prior to Baseline for >72
hours;
- Severe neurological condition before ICU admission that causes the patient to lack
ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
- Ventilator tidal volume <200 or >1000 mL at Baseline;
- Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal
(ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive
ventilation (HFPV) at Screening;
- Comfort care only (end of life care);
- Contraindication to propofol or isoflurane;
- Known or family history of MH;
- Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min
(or equivalent vasopressor dose) to maintain blood pressure within acceptable range,
assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
- Allergy to isoflurane or propofol, or have propofol infusion syndrome.
- History of ventricular tachycardia/Long QT Syndrome;
- Requirement of IV benzodiazepine or barbiturate administration for seizures or
dependencies, including alcohol withdrawal
- Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal
cord injury, amyotrophic lateral sclerosis, etc);
- Concurrent enrollment in another study that, in the Investigator's opinion, would
impact the patient's safety or assessments of this study;
- Participation in other study involving investigational drug(s) or devices(s) within 30
days prior to Randomization;
- Anticipated requirement of treatment with continuous infusion of a neuromuscular
blocking agent for >4 hours;
- Female patients who are pregnant or breast-feeding;
- Imperative need for continuous active humidification through mechanical ventilation
circuit;
- Attending physician's refusal to include the patient; or
- Inability to obtain informed consent.
The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer (NSCLC)
Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer
Patient
- Adults ≥ 18 years with biopsy proven resected NSCLC.
- Appointment to discuss adjuvant treatment of resected NSCLC.
Patient
- Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment).
Clinician
- Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC.
Clinician
- None.
PAG Member
- Adults ≥ 18 years.
- Member of the KER Unit PAG.
PAG Member
- None.
Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.
Outcomes of Treatment with Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study (VNS-PoCoS)
Vagal Nerve Stimulation for Post-COVID Fatigue
- Age ≥ 18 years old.
- Presence of fatigue and post exertional malaise.
- Presence of headache
- Clinical diagnosis of post COVID syndrome.
- They have consented to participate in the study
- They have the ability to participate in all aspects of the study.
- Age < 18 years old.
- Pregnant.
- Prior adverse reaction to 14FDG.
- Active implantable medical device e.g. pacemaker, hearing aid implant
- Metallic device e.g. stent, orthopedic hardware in neck
- Using another electronic device at the same time e.g. TENS, mobile phone.
- Any other condition deemed exclusionary by the study principal investigator
Eligibility last updated 1/26/22. Questions regarding updates should be directed to the study team contact.
A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Spinal Cord Stimulation to Treat Chemotherapy-Induced Peripheral Neuropathy
- Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater
than six months after stopping chemotherapy
- Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower
extremities at enrollment
- Failed conventional medication management with at least two neuropathic pain
medications
- Have electrophysiological evidence of length-dependent peripheral neuropathy
- Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and
reported a successful trial of at least 75% reduction in pain intensity
- Have stable neurological status
- Be on a stable analgesic regimen
- Be an appropriate candidate for surgical procedures required in this study
- Be able to read and understand English-written questionnaires and sign an informed
consent form in English
- Be willing and capable of giving informed consent
- Be willing and able to complete study-related requirements, procedures, and visits
- Patient refusal to be included in study
- Presence of lower limb mononeuropathy
- History of lower limb amputation or ulceration
- Presence of another painful condition that is unrelated to CIPN and that is not
intended to be treated in this study
- Body mass index (BMI) >= 40
- Omeprazole (OME) > 120 mg
- Progressive neurological disease (multiple sclerosis, chronic inflammatory
demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord
tumor, central deafferentation syndrome, complex regional pain syndrome, acute
herniating disc, severe spinal stenosis)
- Certain comorbidities: coagulation/bleeding disorders, diminished capacity from
cardiac/pulmonary disease
- Obtaining another interventional procedure unrelated to SCS to treat limb pain
- Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm.
Included patients must be deemed as in remission per discretion of treating oncologist
- Have a life expectancy of less than one year
- Have untreated addiction or dependency to medications, alcohol, or illicit drugs
- Have active, disruptive, and/or unstable psychological or psychiatric disorder
Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.
Normative Biomechanical Measures of Reaching in Able-Bodied Adults
Reach Normal Controls
- 20-59 years of age at time of enrollment
- Failure to give consent or follow simple commands
- Score of 7 or above on the QuickDASH Outcome Measure
- Score of 5 or above on the Oswestry Low Back Disability Questionnaire
- Score of 76 or below on the Lower Extremity Functional Scale
- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis,
fibromyalgia)
- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional
vertigo)
- Insufficient active range of motion of bilateral shoulders or hips that results in
inability to perform forward or lateral reaching tasks
- Any illness or condition which, based on the research team's assessment, will
compromise the patient's ability to comply with the protocol, patient safety, or the
validity of the data collected during this study
Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.
Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)
Cell Saver During Tumor Resection
- Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.
- Patients undergoing surgery with an expected blood loss of less than 135cc.
- Provisions for inclusion of minorities:
- Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.
Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.